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Clinical Trials
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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
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Medical research
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Clinical Trials
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Not taking part in a trial
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Marie - Interview 25
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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 She was worried about side effects, the fact that the drug might be withdrawn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
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Clinical Trials
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Not taking part in a trial
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Lesley - Interview 44
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She felt this was a decision she had to make for herself. The research assistant accepted her decision and did not try to change her mind.
Lesley slipped and fractured her heel. She was invited to take part in a trial comparing surgery with letting the bones heal naturally. She decided not to take part because she wanted the consultant to make a decision about treatment.
Medical research
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Clinical Trials
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Not taking part in a trial
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Marie - Interview 25
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Marie’s GP spent time discussing her concerns about the trial and her consultant contacted the trial on her behalf to say she was not happy to take pa
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
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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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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
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Clinical Trials
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Not taking part in a trial
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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
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Clinical Trials
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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
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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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Marie - Interview 25
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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
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Clinical Trials
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Cancer drugs and radiotherapy - randomised trials
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Judith - Interview 24
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A relative with multiple sclerosis was upset to find he’d been in the placebo group in a trial. She would not like to be in a placebo-controlled trial
Judith agreed to take part in a randomised trial comparing different intervals of chemotherapy treatment for non-Hodgkin’s lymphoma. She was allocated to the standard treatment and responded well.
Medical research
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Clinical Trials
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Not taking part in a trial
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Lesley - Interview 44
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When Lesley fractured her heel, she wanted to be told by a doctor what to do. She felt being in the trial would make her responsible for choosing, eve
Lesley slipped and fractured her heel. She was invited to take part in a trial comparing surgery with letting the bones heal naturally. She decided not to take part because she wanted the consultant to make a decision about treatment.
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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When his son was dying, Lester wouldn’t have wanted anything to be intrusive. He knows trials are essential, but at the time it was about helping his
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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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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Screening, prevention other medical interventions
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Jenny - Interview 40
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Jenny can’t imagine any condition where she’d be willing to think about a placebo-controlled trial. She recognises the possibility of benefiting from
Jenny is in a trial of different ways of treating heavy periods at her GP surgery. The trial compares standard treatment with a new kind of coil or intrauterine device which releases a hormone in the womb.
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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Even with experience of helping run a trial, he is unsure if he would volunteer if he was terminally ill. Maybe people should carry something like a d
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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Not taking part in a trial
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Hazel - Interview 05
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Hazel felt she did not know enough about the condition or the facts of her own case to make an informed choice about the trial, especially as the four
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
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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Lester advises people to get lots of information. Now he knows more about trials he’d be more likely to take part if his doctor offered one, especiall
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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Long term conditions
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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
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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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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
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Screening, prevention other medical interventions
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Rosamund - Interview 18
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Involving people in research can seem tokenistic, but it’s still useful to have comments on leaflets and questionnaires to make them more understandab
Rosamund is taking part in a large trial testing the effectiveness of screening for ovarian cancer. She is in the control group, so she has no screening tests but completes regular questionnaires.
Medical research
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Clinical Trials
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Not taking part in a trial
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Hazel - Interview 05
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She later discovered some doctors disagreed with radiotherapy as a treatment for DCIS, and were entering their patients only for the tamoxifen or no t
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
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 asks clinicians to treat each person as an individual, respect their choices and give them time to think.
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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Not taking part in a trial
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Hazel - Interview 05
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Staff put no pressure on her to take part, but once she declined they could advise her and reach a shared decision about treatment. In ‘researcher mod
Hazel learnt she had breast cancer (DCIS) after screening in 1991. After surgery she was asked to be in a trial comparing no further treatment with radiotherapy, tamoxifen, or radiotherapy and tamoxifen combined. She declined to take part. (You can see Hazel talking more about her experiences on the Healthtalkonline site on Breast cancer screening, Interview 17 & DCIS, Interview 26).
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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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.
Topic
Medical research
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Clinical Trials
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Deciding not to take part
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Deciding not to take part
Deciding not to take part
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