Studies show that those with a good understanding of the clinical trial process are more likely to take part.
When speaking with potential participants
Explain a clinical trial using this series of steps, making sure the potential participant understands what each step involves before moving to the next:
- Explain the disease or condition.
- Describe current best proven treatment.
- Present the option represented by the clinical trial.
Break the informed consent conference into 2 separate meetings if your patient would prefer this or you think 2 sessions would improve understanding.
Use the Participant Information and Consent Form as a communication tool during meetings by:
- providing copies
- encouraging reading
- referring to sections of the document.
Discuss treatment options outside of the clinical trial and explain how the trial intervention differs from established interventions and current standard care or treatment.
Explain at least 3 times that trial participation is voluntary.
Make it clear that they have the right to withdraw at any time and what withdrawal might mean at different stages in the trial.
For randomised trials, explain the randomisation process and what this means regarding access to the new intervention.
Discuss any potential conflict of interest you have as a researcher.
Be prepared to answer if the prospective participant asks if you would:
- personally enrol in the trial
- advise one of your family members to enrol.
See a list of questions that potential participants may ask.