Abstract
Researchers and institutional review boards often consider it inappropriate for patients to be asked to consent to more than one study despite there being no regulatory prohibition on co-enrollment in most countries. There are however ethical, safety, statistical, and practical considerations relevant to co-enrollment, particularly in surgery and perioperative medicine, but co-enrollment can be done if such concerns can be resolved. Preventing eligible patients from co-enrolling in studies which they would authentically value participating in, and whose material risks and benefits they understand, violates their autonomy - and thus contravenes a fundamental principle of research ethics. Statistical issues must be considered but can be addressed. In most cases each trial can be analyzed separately and validly using standard intention to treat principles; selection and other biases can be avoided if enrollment into the second trial is not dependent upon randomized treatment in the first trial; and valid interaction analyses can be performed for each trial by considering the patient’s status in the other trial at the time of randomization in the index trial. Clinical research with a potential to inform and improve clinical practice is valuable and should be supported. The ethical, safety, statistical, and practical aspects of co-enrollment can be managed, providing greater opportunity for research-led improvements in clinical practice.
Highlights
Large, investigator-initiated randomized clinical trials are able to more fully evaluate the overall effectiveness of new drugs and other treatments in routine practice [1,2,3,4]
Obtaining adequate funding for large clinical trials is, difficult [7] and they often compete for researcher interest and patient recruitment with local research projects and/or pharmaceutical industry-sponsored trials
Of greater importance is that both researchers and institutional review boards (IRBs) often consider it inappropriate for patients to be asked to consent to more than one study despite there being no regulatory prohibition on co-enrollment in most countries [8,9]
Summary
Investigator-initiated randomized clinical trials are able to more fully evaluate the overall effectiveness of new drugs and other treatments in routine practice [1,2,3,4]. For the simplified setting considered above of an initial Trial S followed by potential co-enrollment in Trial T, for co-enrollment to have a large detrimental effect on the sample size of the initial Trial (S), there needs to be a large antagonistic interaction, substantial co-enrollment, and patients not co-enrolled receive treatment T1 at a lower frequency than 50%. Whether this is likely to occur will depend on the particular clinical circumstances of the trials and treatments under consideration. More studies can be done in a timely fashion and more information to guide clinical practice can be generated [3,6,35,36]
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