Q&A Part II: How Protocol Feasibility Assists in Promoting Compliance

Dr. Wendy Tate
Director, Research Operations, Forte
December 19th, 2019

In November, Forte’s Director of Analytics Wendy Tate presented the webinar “How Protocol Feasibility Assists in Promoting Compliance”. She discussed adding a protocol feasibility committee to improve trial compliance and ethics through proper resource allocation, ensuring objectives can be met through proper accrual. After a wide-ranging post-webinar Q&A session, Wendy helped answer some attendee questions we weren’t able to address during the webinar.

Have you experienced a site actually denying a study because the site staff load was higher?

Yes, at my previous institution we put in place a review process and deferred studies for a later start-up for that reason. I also have spoken to other organizations with this process that will deny studies for this reason and also use it as leverage to leadership to vie for more staff.

You mentioned that the first decision to start a project needs to be a business decision and revolves around resources. Do we have the means, is it scientifically valid, is it ethical? I realize that you are discussing feasibility, but this approach totally negates the trend towards patient/participant centricity, meeting the patients’/participants’ needs from their perspective and empowering them. If the first decision is a “business decision,” I see that path as very one-sided. How can you also engage patients/participants as empowered stakeholders in the process? If they are not part of the first decision, then how can we expect them to participate in the research?

Great point! I would actually say that the patient/participant part comes way before any of this.  By the study activation stage, the protocol is written, the objective, procedures and outcome are determined. Participants and patients should be involved in that step to ensure that the research being developed and proposed is meaningful to them. They should have the means to help drive research conduct at the fundamental stage, including what should be studied and have input into how things are studied. Participants are critical to the protocol development stage. At the stage where a protocol is coming to a site, I think there is always room to consider special protocols that may be affecting a rare disease or special patient population. That doesn’t mean you can’t run those protocols if you have a feasibility committee, but in the interest of maximizing the ability to serve the patient population that the organization sees, those protocols need to come through as special considerations. If you use a feasibility committee for decision on more “common disease” protocols (e.g. breast cancer, heart disease, diabetes) that, in theory, have high chances for success, then you can have a reserved section for more “pro bono” or “hard-to-accrue” protocols that may not be as “successful” on the accrual or financial route, but are important to run due to scientific or patient population concerns. The main thing to consider is that you have to run a research program that can be available for the long-term. Opening every single protocol because it seems “neat” or “novel” sounds great but isn’t financially viable. If the organization has to close their clinical research operation because it can’t pay the bills to maintain staff or turn on the lights, then no one gets helped.

Compliance and Regulatory Efficient Clinical Trials