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It’s Time to Give Patients a Seat at the Table


Clinical trials represent a critical path to innovative treatments, life-changing cures, and medical progress. But for all their scientific rigor, most trials fail to include one crucial element: input from the very people they aim to help.

In the past, patients have had little say in how clinical trials are designed. The responsibility of trial design is usually left to academics, clinicians, statisticians, and industry experts. However, a recent study by the Health Stories Project found that 97% of patients believe it is important for biopharmaceutical companies to include patient feedback when designing clinical trials. Additionally, 83% of patients expressed interest in providing feedback. Unfortunately, most trials do not incorporate the patient voice, which leads to 85% of clinical trials failing to retain enough patients to reach completion. This lack of patient involvement has resulted in many trials providing minimal real-world benefits at best and causing harm at worst.

Fortunately, the landscape is evolving. The past decade has seen rising patient advocacy hand-in-hand with regulatory guidance that makes the message clear: patients need and deserve a seat at the table.

Trials that are poorly designed often fail when patients scrutinize them or when real-life pressures are applied. For instance, a treatment that requires daily medical visits might show success under ideal trial conditions. However, when the same constraints are placed on patients who must also balance jobs, families, and comorbidities, adherence often drops to unsustainable levels.

Excluding patients from clinical trials can have a significant impact on engagement. Patients and clinicians have different perspectives when it comes to treatment success and outcomes. Patients, who live with their conditions on a daily basis, are better equipped to determine which outcomes matter most compared to traditional experts. For instance, while mortality reduction may be statistically significant to researchers, clinical treatments that produce such effects may leave patients bedridden and unable to work or take care of their families. By tapping into these experiences and exploring the benefit-risk trade-offs, we can gain valuable insights for designing clinical trials that address the needs of patients effectively.

Involving patients from the very start

To optimize trial meaningfulness and success, researchers must engage with patients and caregivers – who are experts in their own right – through authentic conversations from the onset of trial design.

One way to ensure that a clinical trial is relevant to the everyday lives of patients is to conduct a comprehensive elicitation process. This can be done by organizing meet-and-greets between researchers and patients, during which researchers can gain a deep understanding of the individual stories and experiences of patients with the condition being studied. Additionally, researchers can benefit from self-completion exercises, which involve patients creating their own personal condition timelines and exploring techniques to express both the conscious and unconscious manifestations of their condition.

Patient involvement in clinical trials should not be limited to just participating in the study. Patients should also be involved in defining the trial endpoints to capture their experience during the trial. Factors like the impact of the treatment on their functional limitations, emotional well-being, and social function may provide an additional perspective into the effectiveness of a treatment. To ensure that clinical trials are accessible to a wider demographic and avoid creating barriers, clinicians may consider using decentralized technologies such as wearables and smartphone apps, so that patients can easily report data from wherever they are.

Looking ahead

In the future, there will be a greater effort made by clinical trial providers to facilitate the connection of patients and healthcare providers with relevant clinical trials. For medical professionals and patients, it is important to ensure continued access to diverse healthcare systems that share de-identified data to fuel research and connect patients with suitable trials. This will enable the acceleration of groundbreaking insights and therapies, by involving patients in the development of clinical trials.

Patients are seeking cures, just like the industry and science are striving for breakthroughs. Game-changing advances can be achieved by integrating patient collaboration and priorities into the full span of trial design. In order to guide clinical trials as partners, patients must be given equal footing with research teams, rather than being treated as passive subjects. It is important for the industry to recognize that patients are both beneficiaries and creators of scientific knowledge.

Photo: 9amstock, Getty Images


Christopher P. Boone, Ph.D., is a global executive, strategist, professor, and social scientist with a unique passion for revolutionizing healthcare and life sciences through clinical research informatics, real-world evidence, and health equity. As the Group Vice President of Life Sciences Research Services at Oracle Corporation, Chris steers the function responsible for conducting research that accelerates the discovery, development, and deployment of extraordinary insights and therapies to help transform healthcare and improve patients’ lives. His academic contributions as an adjunct assistant professor at New York University’s Robert F. Wagner Graduate School of Public Service further amplify his impact.



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