Chapter 12 - Working with Study Participants

How many clinical trials fail to enroll the desired number of subjects within the specified enrollment period?

Approximately two-thirds.

What is advertising?

Anything that is directed toward potential study subjects with the goal of recruiting them into the study.

What is generic advertising?

Advertising your site as a study site - doing studies in many different areas - instead of advertising for only one specific study (must also be approved by the IRB).

True or False: Most sponsors also require that sites submit advertising for their approval before it goes to the IRB.

True.

Why must advertisements be approved by the IRB?

To ensure that it is 1) not coercive and 2) does not make promises about a cure or favorable outcome or promise things other than what appears in the protocol or the consent.

True or False: Ads must explain that the test article is a “new treatment”.

False, “new treatment” implies it is a proven and approved product and is not appropriate. Instead, o   Ads must explain that the test article is investigational / C.

Does identification of patients with acute or chronic illnesses typically come from the investigator’s own practice?

Patients with chronic illnesses.P

Which Phase is most likely to attract subjects through the use of compensation?

Phase I, because that is the Phase with healthy volunteers who wouldn’t otherwise benefit.

Why must compensation be approved by the IRB (in advance of being used)?

To ensure that it is not coercive.

What are referral / finder’s fees?

Compensation paid by the investigator to other professionals to encourage them to find study subjects.

What are bonus payments?

Compensation paid by study sponsors to investigators and their staff to enhance enrollment.U

Are referral / finder’s fees and bonus allowed?

Usually, no. They encourage the enrollment of “borderline” subjects or subjects the investigator otherwise would not recruit.

True or false: There is no problem with a sponsor covering true extra costs for enrollment procedures.

True. This includes costs associated with additional personnel to screen potential subjects, advertising costs or other direct costs borne by the investigative site.

Are drop-outs considered in the statistical analysis?

Yes, they are known as “failures”.

How many times do you contact a non-compliant patient before they are considered “Lost to Follow Up”?

At least three times via phone call, followed by a registered letter (with a stamped return envelope included so the patient can reply easily).

Are gifts like mugs, tote bags, doughnuts between Investigator and subject allowed?

Yes (Note to self: I guess these aren’t considered coercive).

What is patient-centricity?

Designing and conducting studies with the patient’s needs, preferences, and experiences as the central focus.

What is the gold-standard for testing for compliance?

Checking blood levels. This is done in some studies, but mostly only in the very early (Phase I and II) studies. It is expensive and is not feasible to do most of the time.

Where should the site document details of non-compliance?

Both in the source documents and the case report form.