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Consent in clinical trials: what do patients know?
Pilar Hereu1, Eulàlia Pérez, Inma Fuentes
1Fundació Institut Català de Farmacologia, Spain. pilar.hereu@telefonica.net
Contemporary Clinical Trials
|May 14, 2010
Summary
Patients in clinical trials often lack knowledge about key aspects like random allocation and potential adverse effects, despite formal consent processes. Investigators also de-prioritize crucial information, highlighting a gap in participant understanding.
Area of Science:
- Clinical Research
- Patient Education
- Informed Consent
Background:
- Informed consent is crucial for ethical clinical trial participation.
- Assessing patient comprehension of trial details is vital for ethical research conduct.
Purpose of the Study:
- To evaluate patient understanding of critical clinical trial elements.
- To describe the informed consent process from the patient's perspective.
- To ascertain the importance investigators place on specific trial information during consent discussions.
Main Methods:
- A prospective study involving structured interviews with 140 clinical trial participants.
- Anonymous questionnaires were administered to 51 clinical trial investigators.
- Data collection occurred within three months of participant enrollment.
Main Results:
- While participants understood the trial's purpose and right to withdraw, knowledge gaps existed regarding random allocation (23%), placebo possibility (57%), and adverse effects (42%).
- Participants who read the information sheet demonstrated better overall knowledge, except for adverse effect risks.
- Investigators ranked compensation, insurance, placebo, and treatment allocation as least important for informing candidates.
Conclusions:
- Formal consent procedures are common, yet significant patient knowledge deficits persist regarding essential trial aspects.
- A disconnect exists between patient understanding and the information investigators deem important.
- Improving participant knowledge may be achieved by encouraging information sheet review and delaying consent form signature.
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