There is no one definition of a patient-centric clinical trial that has resulted in a whole lot of buzz — and cynicism — within the pharma industry. There are, however, essentially 4 elements that all patient-centric clinical trials have in common. Find out what tangible steps sponsors can take to achieve patient centricity within their drug development process—no matter what technology or methodology they use.
By Michael Keens, COO, Firma Clinical Research
EDITORS NOTE: An extended version of this article originally appeared in Applied Clinical Trials under the title Why Patient-centric Clinical Trials Are Easier Said Than Done. It was so popular we updated it and reposted it here for your convenience.
For years the phrase “patient centricity” has been infiltrating the lexicon of the clinical research space, following quickly on the heels of its rise to prominence in hospital-based care, where more engaged and informed patients have been found to have fewer problems and/or readmissions following everything from surgery to emergency room visits.
Within the drug development industry today, it is nearly impossible to avoid mention of patient centricity. The topic has overtaken conference keynotes and sessions, appears faithfully in industry publications, and is often a documented goal for sponsors and CROs alike.
While the industry is significantly citing patient centricity, only a few seem to be taking real, impactful action when it comes to implementing patient-centric clinical trials. Patient centricity shouldn’t be treated as a box to be checked off in a static, one-time act. So, what is it and what should it be? In this article, we offer a definition and then the:
4 Elements of a Patient-centric Clinical Trial
Though the science behind drug development and clinical trials has rapidly increased in complexity, it’s the digital age that has catalyzed patient centricity. Easy access to credible medical information has reduced or removed many of the barriers previously separating pharmaceutical companies, physicians and patients. Physicians and pharmaceutical companies no longer have exclusive access to information regarding illnesses, diseases, and medical conditions, enabling even those patients with the highest respect for their physicians to undertake their own layman’s research, supplementing physician-provided information.
Patient expectations have changed as a result. With the advent of enhanced point-of-location services (i.e., Amazon delivery vs. traveling to shopping malls) and consumer-direct measurement of health (ie., FitBit and Apple Watch health metrics), patients expect to be active participants in their health care and expect participation in clinical trials to be less transactional and more partnership-oriented.
Patient centricity, in short, is about reducing the patient burden.
Innovation is important but shouldn’t be the only avenue we explore as an industry when there is a collection of solutions that have proven to be effective and efficient support for patients and can be implemented immediately. Likewise, while considering the expense of a patient-centric clinical trial is important, it shouldn’t prohibit sponsors and CROs from implementing cost-efficient and effective approaches.
Regardless of how you examine it, a few truths remain:
- 50% of sites are unable to enroll more than a single patient and 85% of clinical trials fail to retain enough patients to continue.
- Those incorporating and supporting patient engagement have a 20% higher rate of drug approval in Phase 3 trials.
It is critical the long-term benefits of a patient-centric approach are included in any cost accounting and proactive trial planning and that patient-centric organizations provide data and information to Sponsors to support the value of the investment.
So how do Sponsors benefit from the successful integration of patient-centric approaches in their clinical trials?
4 Elements of a Patient-centric Clinical Trial
Change isn’t easy. But creating a patient-centric clinical trial doesn’t have to be overly complex or expensive. Here are four approaches Sponsors, CROs and sites can do right now to make a clinical trial more patient-centric.
Patient advisory boards are the most common “first step” on the path to integrating patient centricity and patients (or a proxy advocacy group) the opportunity to review the protocol before finalization. Most Sponsor companies are familiar with this step, which is good but integrating the patient advisory board into trials is less common. Sponsors can advance a more involved approach by fully examining how much the patient advisory board is included in establishing a patient-centric protocol, and balance that against budget and corporate comfort level.
As a Global Patient Advocacy speaker noted at DIA, “Does your company have the appetite, resources, and support to really do patient engagement? Your company needs to baseline their appetite for investment in patient engagement before stating ‘we’re patient-centric.’” Examining team and corporate comfort level when considering a Patient Advisory Board as a singular step or the platform for additional engagement is a true success factor to downstream understanding and clarity.
Communicate to patients the efforts being undertaken and solicit feedback from patients and sites continuously during creation and implementation of the protocol process itself. While many Sponsor companies undertake item #1 above and involve patients within the protocol drafting process, almost none inform trial participants of the efforts already undertaken to include the patient perspective. This lack of communication, and worse, lack of continuous engagement, often results in Sponsors falling into the Minimalist Trap listed above.
Creating an avenue for communication and continuous feedback enables ongoing dialogue and interaction at the site and patient level to increase awareness of trial items through the trial lifecycle. Establishing and nurturing this ongoing feedback allows more rapid response to feedback, increases trial efficiency, and demonstrates a higher degree of overall trial engagement.
Protocols are growing more complex by the minute. Advances in science, including greater diagnostic and biomarker abilities, have made the inclusion of new research additive and further exploratory rather than streamlined. To prevent overburdening patients with tests, visits, and procedures, Sponsors should ensure anything included within the protocol and requested of the patient–a sample, a visit, a process–is tied directly to the primary or secondary endpoint. If it’s not helping answer a scientific question, it’s inclusion should be seriously reconsidered or, at the very least, strongly discussed and justified.
Outside of the patients themselves, patient advocacy groups are the individuals most committed to the value of patient centricity. Engage with them early and often, and recognize the experience, enthusiasm, and support they bring to the patients you’re seeking to serve with your clinical trial. Outside of a medical perspective, Advocacy organizations know these patients better than the Sponsor. As Jessica Riviere noted in a session at DIA, “you can’t learn and read about advocacy, you need to have direct experience and exposure to build that knowledge and skill set.”
Many Sponsor organizations have existing relationships with Advocacy organizations, but often only within their Commercial departments and not within Research & Development. R&D team members should explore any internal connections with the advocacy community as a first step to establishing similar relationships and involvement to enhance their R&D efforts and patient support.
The idea of patient centricity isn’t a fad and it’s not going away. If anything, the drug development industry, and more importantly patients, have come to expect integration and continued enhancement of the patient perspective within drug development. The challenge to the industry now is to better respond to meet these increasing expectations and better serve the needs of our patients. They are, after all, the sole reason clinical trials exist, and we are responsible for serving them as they participate in the drug development process. To do so would not only benefit trial patients, but the overall health system as well.