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Clinical Trials
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Full list of topics
Finding out about a trial :
What are clinical trials and why do we need them?
Different types of clinical trial
Being asked about taking part in a trial
Information and questions
Difficulties finding a trial to join
Deciding whether to take part – risk and benefits :
Reasons for wanting to take part – personal benefit
Reasons for wanting to take part – helping medical science
Deciding not to take part
Thinking about withdrawing from a trial
Why people may not be eligible to join a trial
Being in a trial :
Feelings about being allocated (randomised) to a treatment group
Feelings about being in a placebo-controlled trial
Blinded trials
Non-randomised trial designs and other studies
Side effects and queries
Time commitment, money and other practical issues
Appointments, monitoring, questionnaires
Communication between different health professionals
At the end of a trial :
Feelings when a trial ends
Feedback of trial results
Other issues :
Attitudes to taking part in another trial
Funding and publishing trials
Public awareness and involvement
Under-researched topics/priorities for other research
Messages to other people
Messages to professionals
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Clinical Trials
Subject index
Topic
Medical research
>>
Clinical Trials
>>
What are clinical trials and why do we need them?
>>
What are clinical trials and why do we need them?
What are clinical trials and why do we need them?
Medical research
>>
Clinical Trials
>>
Different types of clinical trial
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Different types of clinical trial
Different types of clinical trial
Clip
Medical research
>>
Clinical Trials
>>
Long term conditions
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Phil - Interview 11
>>
Phil explains what the blood pressure trial was comparing and how people were allocated at random to different groups. He felt safe because he knew th
Phil took part in a trial of medication for high blood pressure and cholesterol. He had some side effects early on, so the medication was changed. He has been very happy with the care provided as part of the trial.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
>>
Wendy felt well-informed and the decision was left entirely up to her. She had two weeks to go away and think about it - more than that might have bee
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Marie - Interview 25
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Marie did not realise at first the doctor talking to her about the trial worked for a drug company and that the drug company was running the trial, no
Marie was diagnosed with chronic lymphocytic leukaemia in 1992. She was recently invited to take part in a clinical trial of a new monoclonal antibody. At first she thought she would take part but after reading all the details decided against it.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Tom - Interview 14
>>
He knew he could stop if the side effects became too bad. He felt the staff explained it well, but not everyone wants as much information as he did.
Tom took part in a phase 2 trial of a new chemotherapy drug for lung cancer in 1993. Without the trial, the only other option at the time would have been palliative radiotherapy.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
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Julian - Interview 33
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Julian asked to be referred to a specialist hospital to take part in a Phase 1 trial. His consultant was a bit worried about the risks, but they discu
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
>>
Amanda wanted to run a trial on herself to see if a change of drug made any real difference to her arthritis, but was held up by the ethics approval p
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Charles - Interview 29
>>
Charles volunteered for two trials on prostate cancer screening and a new treatment for erectile dysfunction. He mainly hoped it would benefit him, an
Charles volunteered for two trials, but ended up unable to take part in either of them. The first time he did not meet the eligibility criteria. The second time was because of an administrative mix-up about his age, and he feels it was not well handled.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Kate - Interview 13
>>
Kate and her husband hoped a trial of grass pollen immunotherapy would improve their hay fever, and also help others in future. Free medication was an
Kate and her husband took part in a trial comparing injections of grass pollen antigen against a placebo as a way to reduce hay fever. Kate was in the experimental group and her husband in the placebo group.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
David - Interview 34
>>
David joined a trial of treatments for asthma because he wanted to learn more about the condition, as well as to help medical research. The expenses p
David volunteered for a placebo-controlled trial of a new treatment derived from mouse DNA to improve asthma symptoms. He later discovered he was in the group taking a lower dose of the treatment, but he would not have minded being in the placebo group.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Phil - Interview 11
>>
Phil joined a trial of medication for high blood pressure mainly to see staff who specialised in his condition and had more time than his GP. Helping
Phil took part in a trial of medication for high blood pressure and cholesterol. He had some side effects early on, so the medication was changed. He has been very happy with the care provided as part of the trial.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Danny - Interview 26
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Danny’s husband learnt he had diabetes when he was being monitored during a previous trial. They both volunteered for another trial because it helps t
Danny joined a trial of high blood pressure medication, but stopped because of side effects. She has concerns about the way some staff communicated with her and a lack of rapport and respect for her as a volunteer interested in her own health.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
>>
She thought being in the trial would mean she would be really well looked after by experts. But after agreeing to take part she never saw the professo
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Anthea - Interview 39
>>
Anthea was determined to give herself the best possible chance of beating cancer after other treatments had failed, but even if the trials don’t help
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Jayne - Interview 03
>>
Jayne is strongly committed to the value of research and wanted something good to come out of her illness – not for herself but for others, including
Jayne had breast cancer aged 33. She wanted to join a clinical trial but her consultant was not interested, so she transferred to another hospital and took part in a trial comparing tamoxifen with tamoxifen plus goserelin (Zoladex).
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
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Julian - Interview 33
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Testing treatments that target people with cancer who have the BRCA genetic mutation may be of direct benefit to his daughters. Julian wants to help t
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
>>
Clinical Trials
>>
Long term conditions
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Elvan - Interview 15
>>
Elvan joined a trial mainly because he hoped it would benefit him but it made little difference to his health. Now looking back he is still glad it ma
Elvan took part in a trial of medication for hypertension. His blood pressure did not improve much, but he felt well cared for and is glad to have taken part. He has since joined another trial in the same unit.
Medical research
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Clinical Trials
>>
Screening, prevention other medical interventions
>>
Tony - Interview 36
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Tony says medical advances cannot be made unless people volunteer. He has benefited from drugs trialled by others in the past, and if he can do the sa
Tony took part in a double-blind, placebo-controlled trial of Viagra (sildenafil) for erectile dysfunction following a prostate operation. He was in the placebo arm but was given Viagra after the trial ended. (Husband of Pam, Interview 21).
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Rose - Interview 17
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Rose volunteered to ‘give something back’. She knew both treatments were tried and tested, and was happy to be in the control group. But she would hav
Rose took part in a trial for people with inoperable lung cancer, comparing radiotherapy alone with radiotherapy plus chemotherapy. She had just radiotherapy. The trial was stopped early because so few people agreed to take part.
Medical research
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Clinical Trials
>>
Long term conditions
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Harry - Interview 07
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Having already completed one trial, Harry didn’t want to join another one run by the same research group. He felt his blood pressure was now fine and
Harry took part in a trial of medication for high blood pressure. He had some side effects early on, but otherwise has been very happy with his care and how well he feels.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Polly - Interview 09
>>
Polly decided not to take part in a placebo-controlled trial of tamoxifen because she felt there was already enough evidence it worked for breast canc
Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
Medical research
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Clinical Trials
>>
Not taking part in a trial
>>
Polly - Interview 09
>>
Polly never felt she got a straight answer about why the trial was needed and whether the doctor would have offered her tamoxifen outside the trial. A
Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
Medical research
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Clinical Trials
>>
Not taking part in a trial
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Elizabeth - Interview 27
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When she told the consultant her decision, he seemed angry, which made her feel vulnerable and upset. She worried that if she had dropped out after ra
Elizabeth was invited to join a trial of chemotherapy for ovarian cancer, but decided not to take part as she knew which treatment she would prefer and did not want to be randomised to another group. She felt the consultant was cross about her decision.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Marie - Interview 25
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She didn’t like the idea that the trial could be stopped whenever they had enough data. She would have felt like a guinea pig.
Marie was diagnosed with chronic lymphocytic leukaemia in 1992. She was recently invited to take part in a clinical trial of a new monoclonal antibody. At first she thought she would take part but after reading all the details decided against it.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Marie - Interview 25
>>
She feels you have to be desperate to go on a trial. She wants to live, so she can look after her sick daughter, but she was not desperate enough to t
Marie was diagnosed with chronic lymphocytic leukaemia in 1992. She was recently invited to take part in a clinical trial of a new monoclonal antibody. At first she thought she would take part but after reading all the details decided against it.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Tom - Interview 14
>>
Tom encourages other patients to think about taking part in a trial if it is offered. You can always withdraw if there are problems, and you will have
Tom took part in a phase 2 trial of a new chemotherapy drug for lung cancer in 1993. Without the trial, the only other option at the time would have been palliative radiotherapy.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Angela - Interview 23
>>
Angela had some distressing side effects. She told staff but kept going because she had made a commitment and wanted to honour it. She knew it was onl
Angela was diagnosed with Parkinson’s disease after taking part in a trial on nerve conduction. She has since been in a randomised trial of different drugs for Parkinson’s and would happily take part in another trial, despite having had side effects.(Angela is also on our Parkinson’s disease site, Interview 10).
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
>>
It was always made clear she could withdraw at any time. She thought about it because of the side effects, but felt it would have been a waste of time
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Harry - Interview 07
>>
After the dose of the drug was increased, Harry had bad side effects. He almost gave up, but the senior clinician explained what had happened and enco
Harry took part in a trial of medication for high blood pressure. He had some side effects early on, but otherwise has been very happy with his care and how well he feels.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
David - Interview 34
>>
After he’d started the trial, there were scare stories about the type of treatment being tested. He felt it was too late to stop, but might have thoug
David volunteered for a placebo-controlled trial of a new treatment derived from mouse DNA to improve asthma symptoms. He later discovered he was in the group taking a lower dose of the treatment, but he would not have minded being in the placebo group.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Danny - Interview 26
>>
Danny stopped taking the trial tablets when she developed side effects, as she thought might happen. She felt staff reacted as if ‘I was no good to th
Danny joined a trial of high blood pressure medication, but stopped because of side effects. She has concerns about the way some staff communicated with her and a lack of rapport and respect for her as a volunteer interested in her own health.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Sarah - Interview 38
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Sarah found it quite inconvenient continuing the injections even when she was on honeymoon – perhaps if she had been braver she might have said no ear
Sarah volunteered for a placebo-controlled trial of a drug intended to help women at risk of osteoporosis. It involved daily injections and eventually she dropped out of the trial. (You can see Sarah talking more about her experiences on the healthtalkonline site osteoporosis, Interview 27).
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Sarah - Interview 38
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She withdrew from the trial when a family member was taken into hospital. The smell of the injections started to upset her because it reminded her too
Sarah volunteered for a placebo-controlled trial of a drug intended to help women at risk of osteoporosis. It involved daily injections and eventually she dropped out of the trial. (You can see Sarah talking more about her experiences on the healthtalkonline site osteoporosis, Interview 27).
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Sarah - Interview 38
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Sarah wouldn’t take part in another trial involving anything invasive. She started a trial of lipids medication, but was disappointed to learn she was
Sarah volunteered for a placebo-controlled trial of a drug intended to help women at risk of osteoporosis. It involved daily injections and eventually she dropped out of the trial. (You can see Sarah talking more about her experiences on the healthtalkonline site osteoporosis, Interview 27).
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Sabiha - Interview 19
>>
As a diabetic, she knew she was at risk from high cholesterol. She was glad to learn her cholesterol levels were too low to join the trial, but disapp
Sabiha took part in a trial of breast screening for younger women (under 50). More recently she volunteered for a trial of cholesterol-lowering drugs but was not eligible because her cholesterol level was too low.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Charles - Interview 29
>>
He volunteered for another trial, testing a nasal inhaler for erectile dysfunction. He checked at the first appointment that he was in the eligible ag
Charles volunteered for two trials, but ended up unable to take part in either of them. The first time he did not meet the eligibility criteria. The second time was because of an administrative mix-up about his age, and he feels it was not well handled.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Charles - Interview 29
>>
After a lengthy second appointment, an administrator spotted that he had just turned 66, so he was told he was ineligible. He felt it was badly handle
Charles volunteered for two trials, but ended up unable to take part in either of them. The first time he did not meet the eligibility criteria. The second time was because of an administrative mix-up about his age, and he feels it was not well handled.
Medical research
>>
Clinical Trials
>>
Mental health trials
>>
Anton - Interview 28
>>
Anton does not take no for an answer and will go to great lengths to persuade staff to include him in a trial, even if he does not meet the eligibilit
Anton has a long history of depression and has volunteered for several different trials in mental health, including trials of talking therapies as well as drug trials.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Danny - Interview 26
>>
When it was discovered her summer holiday clashed with the next trial appointment, Danny was told she might be excluded. The word ‘excluded’ made her
Danny joined a trial of high blood pressure medication, but stopped because of side effects. She has concerns about the way some staff communicated with her and a lack of rapport and respect for her as a volunteer interested in her own health.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
>>
It was an anxious time waiting to hear which trial group she was in. She’d have felt cheated if she had been in the control group, but would have stay
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Phil - Interview 11
>>
Phil explains how the cholesterol-lowering drug and placebo were blinded, but he guessed he might be taking the active drug because his cholesterol le
Phil took part in a trial of medication for high blood pressure and cholesterol. He had some side effects early on, so the medication was changed. He has been very happy with the care provided as part of the trial.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Julian - Interview 33
>>
Julian joined a Phase 1 prostate cancer trial hoping it would benefit him, but also to help find out if the drug is safe for others. Phase 2 trials of
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Anthea - Interview 39
>>
The doctors explained very honestly their uncertainty about the treatment and the risks. Careful monitoring is important.
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Anthea - Interview 39
>>
The drug company running the trials paid petrol money for people driving to the hospital, but Anthea would have taken part anyway.
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Marie - Interview 25
>>
The information leaflet was complicated and reading it made Marie angry. She was worried about side effects, the fact that the drug might be withdrawn
Marie was diagnosed with chronic lymphocytic leukaemia in 1992. She was recently invited to take part in a clinical trial of a new monoclonal antibody. At first she thought she would take part but after reading all the details decided against it.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Anthea - Interview 39
>>
Anthea completed a 12-month trial of interferon. When the melanoma returned, she joined a trial of Taxol (paclitaxel), but was advised to stop early b
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
>>
Amanda’s main motivation is to contribute to medical knowledge and test whether there really is evidence for treatments we assume are effective.
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Sarah - Interview 38
>>
Doing your best to help others is important – if being in a trial also helps you as an individual, so much the better.
Sarah volunteered for a placebo-controlled trial of a drug intended to help women at risk of osteoporosis. It involved daily injections and eventually she dropped out of the trial. (You can see Sarah talking more about her experiences on the healthtalkonline site osteoporosis, Interview 27).
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Phil - Interview 11
>>
At the end of the trial participants were invited to a big meeting where the results were presented and explained. It felt very satisfying to be part
Phil took part in a trial of medication for high blood pressure and cholesterol. He had some side effects early on, so the medication was changed. He has been very happy with the care provided as part of the trial.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Elizabeth - Interview 27
>>
It is important that trial results are explained to participants, whether they are positive or negative. People will find out one way or another, and
Elizabeth was invited to join a trial of chemotherapy for ovarian cancer, but decided not to take part as she knew which treatment she would prefer and did not want to be randomised to another group. She felt the consultant was cross about her decision.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Anthea - Interview 39
>>
Anthea always asks lots of questions about how the trial is going, but that’s a personal choice to have lots of information. She’s not sure if she wou
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
>>
Clinical Trials
>>
Organising trials
>>
Sir Richard Doll - Interview 31
>>
Sir Richard Doll, a pioneer of clinical trials, explains an early attempt to run a randomised trial with wounded soldiers during WWII, and the lack of
Sir Richard Doll was one of the doctors who first demonstrated the link between lung cancer and smoking. He was Warden of Green College, Oxford. He was interviewed shortly before his death, in 2005.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
>>
She experienced many of the side effects she was told might happen. It was a worrying list, but she’s glad she was well prepared before agreeing to ta
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Anthea - Interview 39
>>
Anthea knew she could withdraw if she had bad side effects, but in fact they were generally mild. Only once at the beginning she had to stop for a wee
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
>>
Clinical Trials
>>
Mental health trials
>>
Fenella - Interview 20
>>
Every trial has some risk, but medical research is carefully regulated to protect patient safety, and not all trials are about drugs.
Fenella took part in a randomised trial of partial hospitalisation compared to standard community treatment for borderline personality disorder. Results showed the group she was in (partial hospitalisation) had better outcomes.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Harry - Interview 07
>>
Trials are designed to find out things that don’t work. Doctors are there to help, and if you have any problems you should tell them straight away and
Harry took part in a trial of medication for high blood pressure. He had some side effects early on, but otherwise has been very happy with his care and how well he feels.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Danny - Interview 26
>>
Danny noticed there seemed to be a pattern that the side effect of coughing happened when she hadn’t eaten for a while. The researcher wasn’t interest
Danny joined a trial of high blood pressure medication, but stopped because of side effects. She has concerns about the way some staff communicated with her and a lack of rapport and respect for her as a volunteer interested in her own health.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Pam - Interview 21
>>
Pam was told grapefruit, evening primrose oil and antibiotics can interact with the trial drug (lapatinib). She had bad side effects when she took an
Pam has breast cancer which spread to her bones and liver. She joined an open-label expanded access study of lapatinib and capecitabine, before lapatinib was licensed for general use. She left the study after lapatinib stopped working. (Wife of Tony, Interview 36)
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Marie - Interview 25
>>
She had heard bad things about commercial trials. She thought a trial in an NHS hospital would be run by the NHS and was worried to discover it was ru
Marie was diagnosed with chronic lymphocytic leukaemia in 1992. She was recently invited to take part in a clinical trial of a new monoclonal antibody. At first she thought she would take part but after reading all the details decided against it.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Kate - Interview 13
>>
There are strict regulations in place to protect patient safety, so the risk of something going seriously wrong in any trial is very small. Lessons ha
Kate and her husband took part in a trial comparing injections of grass pollen antigen against a placebo as a way to reduce hay fever. Kate was in the experimental group and her husband in the placebo group.
Medical research
>>
Clinical Trials
>>
Organising trials
>>
Lester - Interview 06
>>
Drug companies will of course research products in order to make money, but the UK has a good system of regulation. Lester is more worried about wheth
Lester’s son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Celia - Interview 12
>>
Celia argues for more government research funding. She feels drug companies tend to fund research into small refinements to existing treatments, so th
Celia took part in a randomised controlled trial comparing different periods of radiotherapy for lymphoma. She was would have preferred the shorter course; she was allocated to the longer course but took part anyway.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Julian - Interview 33
>>
The costs of developing new drugs are high, so Julian thinks investment from drug companies is inevitable. But it worries him that there are few incen
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Caroline - Interview 08
>>
Caroline argues that the research agenda is partly driven by the interests of drug companies and popular charities. As a result preventive medicine an
Caroline’s first baby was born by emergency caesarean. In her next pregnancy she took part in a trial comparing different types of information and decision aids about birth choices for women after a previous caesarean. She chose to attempt a natural birth.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Tony - Interview 36
>>
Tony thinks there are conspiracy theories about the role of the pharmaceutical industry, but he keeps an open mind and does not begrudge them their pr
Tony took part in a double-blind, placebo-controlled trial of Viagra (sildenafil) for erectile dysfunction following a prostate operation. He was in the placebo arm but was given Viagra after the trial ended. (Husband of Pam, Interview 21).
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
>>
Amanda worries that commercial trials may suppress ‘negative’ findings. Good research is not cheap, and she feels it should be nationally funded, with
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Screening, prevention other medical interventions
>>
Amanda - Interview 22
>>
Amanda was a member of a research ethics committee and was surprised it was not seen as not part of their role to insist on full publication as a cond
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
>>
Clinical Trials
>>
Long term conditions
>>
Kate - Interview 13
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Kate’s charity worked on a study with a drug company, and they found it really difficult to get the results published. She felt the reviewers were pre
Kate and her husband took part in a trial comparing injections of grass pollen antigen against a placebo as a way to reduce hay fever. Kate was in the experimental group and her husband in the placebo group.
Medical research
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Clinical Trials
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Organising trials
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Lester - Interview 06
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It takes a long time for most trial results to be published. Sometimes when results seem disappointing, researchers may want to carry on, hoping a tre
Lester’s son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.
Medical research
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Clinical Trials
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Mental health trials
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Fenella - Interview 20
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More mental health research is important, including into depression after a physical illness has been diagnosed, and into treatments which are not dru
Fenella took part in a randomised trial of partial hospitalisation compared to standard community treatment for borderline personality disorder. Results showed the group she was in (partial hospitalisation) had better outcomes.
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Julian - Interview 33
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Julian argues that basic biology research is essential, and may come up with more targeted ways to tackle cancer, rather than our current ‘blunderbuss
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Amanda - Interview 22
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Amanda has worked on reviews of evidence about medical treatments, and is still shocked sometimes to find out how little evidence we have for some thi
Amanda has taken part in a trial of pro-biotic yoghurt for irritable bowel syndrome, and withdrew from a trial about early interventions to prevent diabetes. She is setting up a website for the public to design their own trials.
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Anthea - Interview 39
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Anthea describes what a Phase 1 trial is. No-one knows what the side effects will be and whether it will work, but she is very closely monitored.
Anthea was diagnosed with malignant melanoma in 2000. She has been in a randomised trial of treatment with interferon and is now in a phase 1 trial of a combination of drugs which attack the DNA of cancer cells.
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Tom - Interview 14
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Tom was invited to join a non-randomised Phase 2 trial of chemotherapy for inoperable lung cancer. He knew it might not help him, but might help other
Tom took part in a phase 2 trial of a new chemotherapy drug for lung cancer in 1993. Without the trial, the only other option at the time would have been palliative radiotherapy.
Medical research
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Clinical Trials
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Cancer drugs and radiotherapy - randomised trials
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Wendy - Interview 02
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Wendy was asked to take part in a year-long trial of chemotherapy for bowel cancer. She thought it might be ‘too selfish’ to take part if it affected
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Leslie - Interview 43
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Leslie thinks there is too much secrecy around drug company trials, and feels they are more interested in profit than safety.
Leslie took part in a placebo-controlled drug trial of rofecoxib (Vioxx) for prostate cancer prevention. He became extremely ill, but doctors monitoring his progress did not pick up his symptoms. He took the drug company to court, and won compensation.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Leslie - Interview 43
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During the trial, Leslie became more and more ill, but the trial staff didn’t seem to connect his symptoms with an effect of the trial drug estimated
Leslie took part in a placebo-controlled drug trial of rofecoxib (Vioxx) for prostate cancer prevention. He became extremely ill, but doctors monitoring his progress did not pick up his symptoms. He took the drug company to court, and won compensation.
Medical research
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Clinical Trials
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Screening, prevention other medical interventions
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Tony - Interview 36
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Tony explains why he took part in an early placebo-controlled trial of Viagra (sildenafil) for erectile dysfunction, and why testing against a placebo
Tony took part in a double-blind, placebo-controlled trial of Viagra (sildenafil) for erectile dysfunction following a prostate operation. He was in the placebo arm but was given Viagra after the trial ended. (Husband of Pam, Interview 21).
Medical research
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Clinical Trials
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Long term conditions
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Sergio - Interview 37
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Sergio was told at the end of the trial he had been taking the active drug, but his diabetes symptoms had not changed. He always understood the trial
Sergio has taken part in several trials, including a placebo-controlled trial of diabetes medication, and a trial of talking therapy for depression. He likes to volunteer to support medical research.
Medical research
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Clinical Trials
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Not taking part in a trial
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Charles - Interview 29
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He did not mind the idea of a placebo, and would have been curious to see if he was susceptible to the placebo effect. He might have dropped out if he
Charles volunteered for two trials, but ended up unable to take part in either of them. The first time he did not meet the eligibility criteria. The second time was because of an administrative mix-up about his age, and he feels it was not well handled.
Medical research
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Clinical Trials
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Mental health trials
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Anton - Interview 28
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Anton has taken part in many trials comparing different treatments, but would never agree to be in a placebo-controlled trial.
Anton has a long history of depression and has volunteered for several different trials in mental health, including trials of talking therapies as well as drug trials.
Medical research
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Clinical Trials
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Not taking part in a trial
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Polly - Interview 09
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She would probably have taken part if tamoxifen had been available only through a clinical trial. She is not against placebo-controlled trials in prin
Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
Medical research
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Clinical Trials
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Long term conditions
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Harry - Interview 07
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Harry had two unexpected drug interactions when he started taking other drugs alongside the trial drugs. He doesn’t remember anything about it in the
Harry took part in a trial of medication for high blood pressure. He had some side effects early on, but otherwise has been very happy with his care and how well he feels.
Medical research
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Clinical Trials
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Cancer drugs and radiotherapy - randomised trials
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Wendy - Interview 02
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The extra side effects meant she had to give up work and lost money as a result. There was a lot of disruption to family life, but they found a new ro
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Pam - Interview 21
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Remembering to take the trial tablets is quite daunting. Pam has to save the empty packets and take them back, though that doesn’t prove she actually
Pam has breast cancer which spread to her bones and liver. She joined an open-label expanded access study of lapatinib and capecitabine, before lapatinib was licensed for general use. She left the study after lapatinib stopped working. (Wife of Tony, Interview 36)
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Julian - Interview 33
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The tablets Julian takes are very large and patients find them hard to take, but this is something that can’t be changed half-way through a trial.
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
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Clinical Trials
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Long term conditions
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Danny - Interview 26
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Danny put her tablets into a dosage box from a previous trial. Staff were very concerned that unused tablets were out of the original packets. If this
Danny joined a trial of high blood pressure medication, but stopped because of side effects. She has concerns about the way some staff communicated with her and a lack of rapport and respect for her as a volunteer interested in her own health.
Medical research
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Clinical Trials
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Long term conditions
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Phil - Interview 11
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Phil was happy with his first experience of a trial, and has recently volunteered for a similar trial. He values the expert supervision.
Phil took part in a trial of medication for high blood pressure and cholesterol. He had some side effects early on, so the medication was changed. He has been very happy with the care provided as part of the trial.
Medical research
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Clinical Trials
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Not taking part in a trial
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Elizabeth - Interview 27
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Elizabeth declined to take part in a trial in early stage ovarian cancer. She felt she did not need extra treatment and was worried about side effects
Elizabeth was invited to join a trial of chemotherapy for ovarian cancer, but decided not to take part as she knew which treatment she would prefer and did not want to be randomised to another group. She felt the consultant was cross about her decision.
Medical research
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Clinical Trials
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Cancer drugs and radiotherapy - randomised trials
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Jayne - Interview 03
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Jayne did not mind being in the control group, even though the new treatment tested in the trial has now become the standard treatment, so she was not
Jayne had breast cancer aged 33. She wanted to join a clinical trial but her consultant was not interested, so she transferred to another hospital and took part in a trial comparing tamoxifen with tamoxifen plus goserelin (Zoladex).
Medical research
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Clinical Trials
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Long term conditions
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Sergio - Interview 37
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Sergio was not worried about whether he got the placebo or the active drug. Since the case at Northwick Park, he has been more wary of the possible ri
Sergio has taken part in several trials, including a placebo-controlled trial of diabetes medication, and a trial of talking therapy for depression. He likes to volunteer to support medical research.
Medical research
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Clinical Trials
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Cancer - Non-randomised studies
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Julian - Interview 33
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He can see that often a placebo might be safer than the trial drug. But in his case, he feels the evidence is already so strong he would not be happy
Julian has prostate cancer. He is in a Phase 1 trial of a drug (a PARP inhibitor) which may stop cancer cells regrowing in people like him who have the BRCA2 genetic mutation. This mutation increases the risk of prostate and other cancers.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
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Wendy would like to have been told in advance that she wouldn’t see the professor every time. There was little continuity of care and staff always see
Wendy was invited to take part in a chemotherapy trial after being diagnosed with bowel cancer. She decided to take part, and was allocated to the experimental group. She experienced quite severe side effects but continued to the end of the treatment.
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