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Medical research
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
>>
Clinical Trials
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Cancer drugs and radiotherapy - randomised trials
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Rose - Interview 17
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It is important for staff not to try to influence you. If you say yes just because you like the researcher it could cause problems.
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
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Cancer - Non-randomised studies
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Tom - Interview 14
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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
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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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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
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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
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Judith - Interview 24
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Consenting to the trial was not a huge decision. Both groups had chemotherapy, one every two weeks and one every three weeks. She would have preferred
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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Cancer drugs and radiotherapy - randomised trials
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Wendy - Interview 02
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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
>>
Cancer - Non-randomised studies
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Anthea - Interview 39
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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
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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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It’s important to tell people about trials, but she wonders if clinicians always appreciate the commitment they’re asking people to make, the side eff
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 - 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
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
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
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Wendy - Interview 02
>>
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
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Pam - Interview 21
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Pam finds her regular scans reassuring. Talking to fellow patients helps keep her spirits up, and the nurses are very encouraging. Hospital feels like
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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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)
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