The Imperative of Incorporating the Patient Voice in Clinical Trials
Brett L. Kinsler
Expanding the reach of scientific discoveries for University of Rochester, especially COAs, PROs & ObsROs | HealthIndexes.com
This week I again saw the release of exciting results from the early stages of a new drug study. It's great news and holds fantastic promise for people who are suffering from a disease with no current cure. Unfortunately, the study failed to include a patient-reported endpoint early on.
As healthcare professionals and researchers, we often turn to data, clinical expertise, and advanced technologies to guide the development of new therapies such as this one, but it is crucial to remember that the patient -- the one who lives with the condition every day -- brings an invaluable perspective. The patient is not just a data point; they are the ones experiencing the nuances of the lived experience, from its symptoms to its impact on daily life. The patient is the one with the disease.
Patients possess deep insights into subtleties that may not be immediately apparent, or even deemed important, through clinical observations. They can identify which treatments offer real relief, the side effects that affect their quality of life, and the practical challenges they face in adhering to a treatment regimen. Often, providers are surprised as to the patient's priorities.
For this reason, involving patients in the design and execution of clinical trials is not just beneficial, it is essential. Whether in protocol design, endpoint selection, or trial feasibility assessments, patient input leads to more relevant and effective trials, improved recruitment and retention, and ultimately, the development of therapies that better address the needs of those we aim to serve.
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One important step in the integration of the patient voice is including regulatory-grade patient-reported outcome measures in any interventional trial, and the more sensitive to the particular disease being studies, the better.
We live in an era of personalized medicine, and extending this to drug development is not an option; it’s a responsibility. We must recognize the patient as a core collaborator in order to accelerate innovation and ensure that clinical advances truly reflect the realities of those living with the disease.
#PatientCentricity #ClinicalTrials #PatientVoice #DrugDevelopment #PatientReportedOutcomes #HealthIndexes
President, Strategic Interests, LLC
5 个月Thanks Brett. Well done. Why NOT include patient perspective in designing clinical trials? Yet it is considered novel.
Board Member and Freelance Advisor with expertise in Patient Engagement for drug development.
5 个月Very nicely put! It is incredible to think that some people with serious decision making power, would rely on assumptions, rather than ask those living with the disease... Despite so much at stake.