Comment on “Ready-to-Recruit” or “Ready-to-Consent” Populations?

A good introductory piece by Jill Fisher, and too much to comment on in 250 words. I’ve decided to focus on the significance of recruitment times and the state of accrual. In the clinical trial context, meeting accrual targets is make-or-break, regardless of the trial phase. The state of being: “ready-to-recruit” is valuable to the success of any given clinical trial. Investigators are under much pressure to accrue subjects. Sometimes there are financial gains in the form of per-case-funding, in other instances, investigators might have an invested interest in the success of the study and so they are eager to accrue. In all cases, if a trial doesn’t accrue quickly enough then it will likely stop before meeting its accrual targets. Sometimes the data can be salvaged, and sometimes currently enrolled subjects can continue receiving experimental treatment, but these are optimistic outcomes.

Potential subjects create an ethical dilemma in the clinical trial context. If a patient is terminally ill, and has exhausted standard treatment options, then participating in a clinical trial may be one of the few remaining options. There may be ‘promising data’ that suggests that this particular patient may benefit. An investigator is also likely aware of the significance this patient may have to the overall success of a trial. Technically, other patients who are currently participating are counting on more patients to join. Perhaps those patients aren’t aware of this, but they are in a way participating in a groupon like system, where the subjects only ‘benefit’ if others join in. It’s conceivable that an investigator’s role can be conflicted when balancing the interests of currently participating subjects, the potential success of a study, and the potential enrolment of a patient.

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