Having a patient-centered approach is a positive trend in sponsored clinical trials as more companies reach out to seek input from patients. Pa­tient feedback can assist protocol developers in the creation of clinical trials that are more appealing to study volunteers. The input that patients are providing may be just as expected or it may be completely surpris­ing, yet incorporating the feedback into a fully developed strategy or protocol is not an easy task.

According to IMS Consulting Group, which surveyed life science executives in the U.S. and EU, although the majority of companies have attempted patient-centric initiatives, 68% reported that the attempts have not been successful. There are multiple reasons that patient-centric initiatives may be perceived as unsuccessful. Inadequate resources, timing of the initiative or lack of process can all be major stumbling blocks.

It is not easy to determine the return on investment from patient-centric initia­tives, which explains why so many of the initiatives may be underfunded. Fifty-eight percent of those surveyed by IMS believed that “their companies did not adequately resource their patient centricity efforts.” Ask­ing patients for their opinions can increase funding needs if you actually implement the feedback. For example, putting patient re­cruitment materials in front of patients may result in a total re-work of the materials. The re-work will cause a scope increase, yet the effectiveness of having materials more relat­able to patients is not easily measurable.

Timing can also lead to limited success for patient-centric initiatives. Getting patient input as early as possible is always ideal, but because patient input is valuable at any juncture, the impact of the feedback may be minimal depending on the timing of the study. Obtaining patient insights on a pro­tocol is easier than changing the protocol to incorporate it. For instance, if you have a protocol that is final and you realize that a procedure is not feasible for half of your study population (e.g., fasting visits in type 2 diabetes patients), there is no easy way to change the protocol to match the patient input. There are operational things that can be done in this case, such as having meals for study volunteers at the site, but the op­portunity to impact the actual design of the study is not realistic.

When embarking on new initiatives, new processes must be developed. In order to get patient-centric initiatives off the ground in time to have the most impact, implemen­tation is likely occurring without the benefit of established processes. Implementing something new and designing processes simultaneously is not an ideal situation for success. Fifty percent of the people sur­veyed in the IMS study admitted that they had encountered a lack of organizational structure and processes regarding patient-centric initiatives. Furthermore, nearly 60% stated that their organizations don’t have a consistent understanding of, or definition for, “patient centricity.” This clearly speaks to a need for education and processes.

The good news is that 38% of those surveyed had reported success. Another encouraging point is that although barriers such as funding, timeline and processes ex­ist, these barriers can certainly be overcome. While implementing something new is always hard, with a little initial success, we have learned lessons that will enable more robust funding, early involvement and defined processes to allow for successful implementation of future patient-centric initiatives.

Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment exper­tise, strategy and leadership as Principal Consul­tant of Accelerate Clinical Enrollment LLC. Email tointon@icloud.com or tweet @AshleyTointon.

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