ACGT: What questions should a patient ask his physician, if he/she wants to be enrolled in a clinical trial?

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What questions should a patient ask his physician, if he/she wants to be enrolled in a clinical trial?

A few questions a patient should ask his treating physician are given below:

Regarding the Trial:

What are the objectives/ the purpose of the trial?
How to design a trial (e.g. Eligibility criteria's)?
What is the actual knowledge?
How is the patient's safety monitored?

Who is responsible physician, the principal investigator?
Who is the sponsor of the trial?
Is there an insurance covering the risks of the trial?
Which diagnostic procedures and treatment will be given?

How long will the trial last?
How can the patient get access to results of the trial?
What are the possible risks and benefits of the trial?

What are the short-term benefits?
What are the long-term benefits?
What are main side effects?
What are late effects of the disease, the treatment?

Are there other options for the individual treatment?
Are there other trials and how are the risks and benefits compared with the chosen trial?
Will blood or tissue be stored for research?

What type of research will be done?
Where are data stored?
Who has access to data?
Are personal data pseudonymised / anonymised?

Regarding personal issues

What treatment (homeopathy, alternative medicine) is allowed to use in addition to the trial?
What can the patient do in addition to increase treatment success and to prevent relapse?
What are additional costs?
How will the trial and treatment affect daily life?
What are the consequences for the family and friends?
Who can provide additional support during treatment (e.g. psychologist, supporting groups, self regulating groups??

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