Patients want a greater say in clinical trials. Health regulators want sponsors to incorporate patient-centricity into the drug development process. Sponsors want to get on board, too. Now they have the tools to do it.
Benefits of patient involvement
Mary Elmer is executive director of Patient, Caregiver, and Consumer Experience at Merck & Co., and a member of the TransCelerate Biopharma consortium. In the Oct. 10, 2019, Clinical Leader she wrote about collaborating with patients. She says, “Improved patient involvement is beneficial to the entire clinical trial process: Better patient experiences lead to increased study participation and reduced dropout rates, which can, in turn, speed up the delivery of medicines to market.”
Elmer cites a study in Therapeutic Innovation & Regulatory Science. None of the 14 sponsors surveyed had “a consistent, company-wide process for soliciting feedback from clinical study participants.” A major obstacle may be the difficulty of allocating internal resources and cross-functional collaboration required to develop the necessary framework, which must take into account:
- Institutional review board (IRB)/ethics committee (EC) reviews
- Patient experience/engagement teams
TransCelerate BioPharma’s recent launch of its Patient Experience initiative could make a positive difference. It provides a set of tools—including user guides, resource guides, questionnaires and templates—that sponsors, sites and others can use to obtain the patient feedback they need to understand patient experiences and to clinical trials more patient-centric.
Considerations for patient collaborations
Elmer offers some considerations for sponsors who want to incorporate patient voices into their clinical trials. She recommends:
1. Gathering information directly from patients and patient advocates when developing a patient engagement plan. The same is true for other stakeholders such as sites and clinical research organizations.
2. Understanding current regulations, including the 21st Century Cures Act in the United States and the General Data Protection Regulation in the European Union.
3. Building long-term trust with patients and partners through “a level of shared alignment, clarity, and respect between invested groups.”
We would add a fourth critical recommendation: In order to eliminate the potential for bias and get the most useful patient experience data, consider using the TransCelerate tools in partnership with an independent vendor who has expertise in facilitating and moderating panels designed to elicit the voice of the patient in clinical trials, as well as experience working successfully with IRBs/Ethics Committees and maintaining compliance in the current regulatory environment.
If you want to jump-start your organizations use of the TransCelerate Patient Experience tools to incorporate patient-centricity in your clinical trials, please email Ross Weaveror call (484) 202-6630.
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