Trial Participants: Informed Consent, GCP, Patient Involvement

3. How Are Patients Informed About A Trial?

3.1. Information Used To Recruit Participants For Clinical Trials

Regardless of the route used to reach out to potential participants, all advertisements for trial participants should be included in the CTA (as part of the protocol) to be reviewed by the REC.

The format used to recruit participants in the advertisements can be diverse; however, the advertisements should always:

  • Include the contact details for the organisation running the clinical trial.
  • State the disease studied and purpose of the trial.
  • Give the criteria to determine when a patient can take part in the trial.
  • Mention the time needed for completing the trial.
On the other hand, advertisements must not:

  • Promise a good outcome or a cure for the disease the patient has.
  • Be coercive, especially when a trial is trying to recruit vulnerable patients, such as those with learning difficulties.
  • State that the medicine being tested is safe or that it works. In the UK the ‘OK to ask’ campaign is run by the National Institute for Health Research and is aimed at promoting the fact that it’s good to ask about clinical research (here).