Disclose Possibility of Early Termination in Informed Consent: IRB
(Thursday, April 6, 2023)
A clinical trial may terminate early for a number of reasons unrelated to the safety of the investigational product. A survey of informed consent documents found that most of them do not acknowledge the possibility of early termination of the trial and the potential direct or indirect consequences for the participants for the same. Should IRBs require the sponsor to include such elements in the informed consent? The regulations require disclosure of all potential risks in a given clinical trial to the study participants in the informed consent. Traditionally that includes all the potential adverse effects from the investigation product, and logistical and financial expectations. When a trial is terminated early due to inadequate participant enrollment or other nonscientific reasons, the participants may feel discouraged or disheartened which in turn may turn them off from future participation in similar trials. Many patient support groups, sponsors and physicians encourage patients to participate in clinical trials for societal benefits. It is common to include language indicative of overall benefits to the generation of new knowledge in the trial even if the participant does not benefit directly. This is a particularly important reason for participation in a placebo-controlled clinical trial where the participant knows that she/he may be randomized to the placebo arm of the study. For such patients, a major motivator is the successful completion of the trial. Knowing that the trial they are participating in may terminate for lack of accrual or other non-scientific reasons, may influence their decision to participate. For the sponsors, predicting the early termination of their trials is not only impractical but potentially hurtful. Although more than 50% of trials are affected by low recruitment issues, and any sponsor can face financial challenges that affect completion of their trial, no sponsor would want to discuss this practical aspect of their clinical trial operations in the informed consent. A compromise may be a general verbiage about the potential early termination of the trial without belaboring on the nitty-gritty. Participants should be aware that a trial may terminate for reasons beyond the controls of the sponsor, and that may not affect their decision to participate, just like knowing that the investigational drug may cause severe side effects does not deter a motivated patient to enroll.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC