With patient-driven clinical trials being a focal point of the 15th Annual Outsourcing in Clinical Trials East Coast conference, experts discussed the value of patient-centricity in clinical trials. The conference was held on 21 – 22 May in King of Prussia, US.

The key to patient centricity is knowing your population and not losing sight of the human side when developing a clinical trial protocol, said Kelly Franchetti, global head of growth and Insights at patient-owned cooperative Savvy Cooperative.

“Are you talking to that patient population? And actually talking to them, not the ecosystem that surrounds them?” she asked.

She also explained that it is important to understand everything a sponsor is offering within that clinical trial is meeting their expectations.

“It is important to understand the distribution of prevalence of disease worldwide and craft an inclusive strategy because not defining the patient population at the human level without geographic boundaries is a fundamental challenge, said Harsha Rajasimha,” founder and executive chairman of Indo-US Organization for Rare Diseases.

“We have an industry where 90% of clinical trials are conducted in 5% of the countries.”

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While patient feedback is often sought after the implementation of a trial protocol, patient insights should be known at the earliest time for a study to be truly patient-centric, said Franchetti.

Experts also agreed that another point of consideration is that patient centricity and patient advocacy are not the same. In the context of rare diseases while advocacy begins with the identification and diagnosis of the first patient, and subsequently a collective push towards legislative acts, centricity revolves around clinical trial stakeholders acting to benefit patients but using different approaches, said Rajasimha.

“Different stakeholders of a clinical trial need to keep the house in order with operational efficiency so patients not only feel invited but included,” explained Rajasimha.

“In the vaccine space, where clinical trials are conducted in a general population, patient centricity means mitigating vaccine hesitancy, boosting vaccine confidence and alleviating vaccine fatigue,” said PMP, Associate Director of Clinical Research at Merck Research Laboratories, Rosanne Petros.