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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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Trials involving surgery
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Merilyn - Interview 41
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Merilyn gets on really well with the research nurse and feels comfortable talking to her. That helped when she had to decide quickly whether to take p
Merilyn took part in a randomised trial of different procedures for carrying out a heart bypass operation. She was in the group which had the new procedure.
Medical research
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Clinical Trials
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Trials involving surgery
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Merilyn - Interview 41
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Merilyn was quite pleased when she found out which type of by-pass surgery she had been allocated to, but she didn’t really mind either way.
Merilyn took part in a randomised trial of different procedures for carrying out a heart bypass operation. She was in the group which had the new procedure.
Medical research
>>
Clinical Trials
>>
Trials involving surgery
>>
Merilyn - Interview 41
>>
Follow-up after the trial doesn’t include questions about the surgical scar and post-operative pain, or about wider lifestyle issues, which Merilyn fi
Merilyn took part in a randomised trial of different procedures for carrying out a heart bypass operation. She was in the group which had the new procedure.
Medical research
>>
Clinical Trials
>>
Trials involving surgery
>>
Alex - Interview 45
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Alex understood doctors were unsure whether to recommend surgery for heel fracture or not. He had a slight preference for surgery but random allocatio
Alex fractured his heel in 2007. He agreed to take part in a trial comparing surgery with letting the bones heal naturally. He was randomised to the group having surgery, and his heel is slowly recovering.
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.
Topic
Medical research
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Clinical Trials
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Different types of clinical trial
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Different types of clinical trial
Different types of clinical trial
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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It was hard being asked about a trial when she was feeling shocked and worried. But she understands that timing is important when treatment decisions
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
>>
Clinical Trials
>>
Trials involving surgery
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Alex - Interview 45
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Alex wonders if he got faster access to diagnostic tests because he’d agreed to be in the trial, but he thinks the quality of care overall was no diff
Alex fractured his heel in 2007. He agreed to take part in a trial comparing surgery with letting the bones heal naturally. He was randomised to the group having surgery, and his heel is slowly recovering.
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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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
>>
Clinical Trials
>>
Not taking part in a trial
>>
Lesley - Interview 44
>>
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
>>
Clinical Trials
>>
Trials involving surgery
>>
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
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Clinical Trials
>>
Trials involving surgery
>>
Ronny - Interview 42
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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
>>
Trials involving surgery
>>
Merilyn - Interview 41
>>
Since the bypass surgery she has had pain for several years. She wonders whether it was because of the new way the operation was done as part of the t
Merilyn took part in a randomised trial of different procedures for carrying out a heart bypass operation. She was in the group which had the new procedure.
Medical research
>>
Clinical Trials
>>
Trials involving surgery
>>
Merilyn - Interview 41
>>
She has found it hard to deal with how the scar looks. She’d have liked to talk to other women patients about how they felt. The hospital could not of
Merilyn took part in a randomised trial of different procedures for carrying out a heart bypass operation. She was in the group which had the new procedure.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Jayne - Interview 03
>>
Jayne is in favour of more trials in surgery and her own field (dentistry), but explains why it is more complex when the outcome of treatment is depen
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
>>
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.
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