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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
Topic
Medical research
>>
Clinical Trials
>>
What are clinical trials and why do we need them?
>>
What are clinical trials and why do we need them?
What are clinical trials and why do we need them?
Medical research
>>
Clinical Trials
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Non-randomised trial designs and other studies
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Non-randomised trial designs and other studies
Non-randomised trial designs and other studies
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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 - Non-randomised studies
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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
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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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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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Cancer - Non-randomised studies
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Tom - Interview 14
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Joining a trial when you have a serious illness is very different to ‘healthy volunteer’ trials. People need more information and education about tria
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 - Non-randomised studies
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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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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
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Cancer - Non-randomised studies
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Shirley - Interview 16
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The surgical study Shirley was invited to join was to check that local surgeons could perform a particular procedure accurately. She had to have surge
Shirley was invited to join a surgical trial of sentinel node biopsy after she had been diagnosed with breast cancer (DCIS, ductal carcinoma in situ). (You can read more of Shirley’s experience on the healthtalkonline DCIS site, Interview 22).
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 could only get lapatinib through an open-label expanded access study. She’d have joined a randomised trial if necessary, but feels NICE should app
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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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
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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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Judith was asked about a trial of a new fibre-optic camera to be used by the anaesthetist during surgery to give a better view of her larynx.
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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Long term conditions
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Kate - Interview 13
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Kate took part in an experimental non-randomised study of a new type of hip surgery. It is only available as part of an audit run by NICE of how safe
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 - Non-randomised studies
>>
Shirley - Interview 16
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The sentinel node biopsy involved little apart from being injected with a dye which showed through her skin for some time after. She is not sure she w
Shirley was invited to join a surgical trial of sentinel node biopsy after she had been diagnosed with breast cancer (DCIS, ductal carcinoma in situ). (You can read more of Shirley’s experience on the healthtalkonline DCIS site, Interview 22).
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