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

Dr. Wendy Tate
Director, Research Operations, Forte
December 12th, 2019

In November, Forte’s Director of Analytics Wendy Tate presented the webinar “How Protocol Feasibility Assists in Promoting Compliance.” Her webinar 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.

We are a newer site, transitioning into more industry studies. Do you have any tips on feasibility reviews to determine which ones we take a hit on in order to get our foot in the door?

This is definitely a more institutionally-driven decision and really depends on the goals of your institution. Because of that, I will speak in extreme generalities. Organizations whose primary “business” is clinical research usually specialize in industry trials. These tend to “pay the bills” and can offer novel treatment options, but do not require a lot of scientific investment on the organization’s end. Organizations that want to contribute to the medical literature and engage in truly new science tend to prioritize the studies that are written by their own investigators. This takes a lot of investment in the protocol development phase, as well as fronting the money and resources to fund the study. These can be in conjunction with industry, so industry studies are still run to help maintain investigator-industry relationships that provide access to these new agents that could be used in institutional protocols for other original reasons. If the organization is looking to be NCI-designated, then there is an expectation of performing NCTN studies as a significant portion of their portfolio as well as contributing to the growth of medical literature by developing trials themselves. In the case of NCI-designated institutions, it is my experience that industry studies are most scrutinized on a resource level so that resources can be designated to institutional and foundation studies. For those organizations, a portfolio of industry studies is kept that represents the leading science in the field and fills in gaps for treatment offerings for the patient population that is served.

Early in the presentation, you mentioned that NCI might be considering a feasibility review requirement. Can you elaborate on this? Would this be part of their application processes or part of their cancer center grants?

That information was part of the NCI’s presentation on proposed changes to the CCSG PAR. So, it hasn’t been released officially or determined to actually occur. They were hinting at expanding the PRMC responsibility to have some sort of feasibility component, likely what is commonly done as part of disease team review for protocol consideration at the beginning of the study activation process. However, the requirements surrounding it (and really, the determination that it must be done) isn’t final.

What advice would you have to help central administration “sell” the process to investigators, who have for so long operated in a more decentralized environment?

Culture change is hard, and investigators can be difficult when it comes to “messing” with their research. I think a critical component is outlining the benefits to investigators when you draw out the scope of the committee. I highly recommend pushing for this committee to have the ability and authority to designate resources to protocols. So, when a protocol is approved to move forward, it is essentially guaranteed the proposed resources to complete the requirements (e.g. a dedicated CRC or ability to draw and process 8 PKs 2 hours apart). That way, it shows that this review is helping them secure what they need to be successful. Of course, that means that this committee must provide the information to know what resources are asked for. In reality, this committee should be one investigators are excited about – but they likely won’t be. When they argue that you are keeping them from doing research, be persistent in telling them, “We may not be approving the resources for this study, but that is so we can guarantee them for another study.” Studies have shown that upwards of 30% of coordinators are willing to leave their position within a year because of workload and stress. If this committee can look at whether there is coordinator workload to utilize in this proposed study, then you have a happier workforce. This will lead to consistent and highly trained staff that investigators can count on, with more effective and streamlined research conduct.

Learn More

Learn more about adding a protocol feasibility committee to improve trial compliance and ethics through proper resource allocation, ensuring objectives can be met through proper accrual in the webinar “How Protocol Feasibility Assists in Promoting Compliance.”

Compliance and Regulatory Efficient Clinical Trials