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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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Organising trials
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Sir Iain Chalmers - Interview 30
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Treatment for prostate cancer can have unpleasant side effects. Because the best way of treating it is uncertain, a trial comparing different treatmen
Iain is a keen advocate for well-designed randomised controlled trials to test treatments.
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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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
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Clinical Trials
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Trials involving surgery
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Ronny - Interview 42
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Ronny agreed to be screened for a prostate cancer trial because he thought it might help his brother who had the condition. He never imagined he too w
Ronny was invited by his GP to be screened for prostate cancer as part of a trial. He discovered he had cancer. He was randomised to have radical surgery (rather than monitoring or radiotherapy) and is pleased with how it went.
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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Trials involving surgery
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Ronny - Interview 42
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Ronny was prepared to let the computer decide which treatment he would have for prostate cancer, but if he had been allocated to radiotherapy he would
Ronny was invited by his GP to be screened for prostate cancer as part of a trial. He discovered he had cancer. He was randomised to have radical surgery (rather than monitoring or radiotherapy) and is pleased with how it went.
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Charles - Interview 29
>>
Charles volunteered for a trial involving prostate cancer testing. He was pleased to discover he was at low risk, as he thinks there is a family histo
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
>>
Trials involving surgery
>>
Ronny - Interview 42
>>
Waiting to hear which group he was in was ‘a long few minutes’. Ronny hoped he’d be in the active monitoring group, but it turned out to be surgery. H
Ronny was invited by his GP to be screened for prostate cancer as part of a trial. He discovered he had cancer. He was randomised to have radical surgery (rather than monitoring or radiotherapy) and is pleased with how it went.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Julian - Interview 33
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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
>>
Julian - Interview 33
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Julian describes the high quality of care and monitoring in his Phase 1 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
>>
Clinical Trials
>>
Cancer - Non-randomised studies
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Julian - Interview 33
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Julian opted to get copies of any letters to his GP, and asks for updates on his own test results. He’d like more opportunities to meet other patients
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
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Julian - Interview 33
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He has sometimes picked up mistakes in the letters sent to his GP from the trial. This is a good reason for patients to see copies of the letters.
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
>>
Organising trials
>>
Sir Iain Chalmers - Interview 30
>>
Iain explains why he thinks randomised trials are the only ethical way to make progress when we don’t know which treatment is best, for example in pro
Iain is a keen advocate for well-designed randomised controlled trials to test treatments.
Medical research
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
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
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
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
>>
Organising trials
>>
Sir Iain Chalmers - Interview 30
>>
Iain explains the worry that screening tests may raise anxiety, especially if it is unclear what to do once a problem is found, as in prostate cancer
Iain is a keen advocate for well-designed randomised controlled trials to test treatments.
Medical research
>>
Clinical Trials
>>
Organising trials
>>
Sir Iain Chalmers - Interview 30
>>
Iain explains the worry that screening tests may raise anxiety, especially if it is unclear what to do once a problem is found, as in prostate cancer
Iain is a keen advocate for well-designed randomised controlled trials to test treatments.
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