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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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Not taking part in a trial
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Gill - Interview 10
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She assumed her local hospital would have plenty of research going on she could join, but when she asked there was nothing suitable for her.
Gill discovered she had breast cancer in 2007. She would have liked to take part in a trial to help other women with breast cancer in future, but none was available.
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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When Jayne learnt she had breast cancer in 1994, she knew it was unclear which treatment was best and asked to join a trial. The consultant was dismis
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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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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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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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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Not taking part in a trial
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Polly - Interview 09
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Polly decided not to take part in a placebo-controlled trial of tamoxifen because she felt there was already enough evidence it worked for breast canc
Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
Medical research
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Clinical Trials
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Not taking part in a trial
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Polly - Interview 09
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Polly never felt she got a straight answer about why the trial was needed and whether the doctor would have offered her tamoxifen outside the trial. A
Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
Medical research
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Jayne - Interview 03
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Jayne explains that blinding to patients and staff is not always possible, but you can still make sure the person analysing the results is blinded to
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
>>
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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Pam - Interview 21
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Pam was told grapefruit, evening primrose oil and antibiotics can interact with the trial drug (lapatinib). She had bad side effects when she took an
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
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
Shirley - Interview 16
>>
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).
Medical research
>>
Clinical Trials
>>
Not taking part in a trial
>>
Polly - Interview 09
>>
She would probably have taken part if tamoxifen had been available only through a clinical trial. She is not against placebo-controlled trials in prin
Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
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
>>
Clinical Trials
>>
Cancer - Non-randomised studies
>>
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
>>
Clinical Trials
>>
Cancer drugs and radiotherapy - randomised trials
>>
Jayne - Interview 03
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Jayne did not mind being in the control group, even though the new treatment tested in the trial has now become the standard treatment, so she was not
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).
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