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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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Cancer - Non-randomised studies
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Pam - Interview 21
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Pam has breast cancer which spread to her bones and liver. Taking a trial drug seemed‘a lifeline’ she could not refuse, despite serious side effects.
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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Mental health trials
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Anton - Interview 28
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Anton says nothing has helped his depression, and he is desperate to try anything. He hopes by taking part in trials he will one day find an effective
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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Long term conditions
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Kate - Interview 13
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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
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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 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
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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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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
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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 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
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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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Screening, prevention other medical interventions
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Amanda - Interview 22
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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
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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.
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