H Clinical News

Life sciences organizations are paying closer attention to ways that improve the patient experience in clinical research trials, while also increasing trial participant enrollment and retention. According to an article by McKinsey & Company that says COVID-19 catalyzed a shift to decentralized clinical trials, typically 70% of potential trial participants live more than two hours from sites (source: Sanofi). Is there an opportunity for sponsors and CROs to step up and bring home clinical trial decentralization?

Bring Home Convenience

Conducting trial activities in participants’ homes became a necessity due to the pandemic. But the inadvertent benefit is that the paradigm shift to decentralization now “broadens trial access to reach a larger number and potentially a more diverse pool of patients” according to the McKinsey article.

Meeting patients where they are requires diverse options to effectively achieve support for hybrid and decentralized clinical trial designs. The article discusses numerous technology elements, including remote monitoring, telehealth and telemedicine, electronic consent, and online portals. However, it does state that “most clinical trials won’t be virtual but will use decentralization elements based on suitability for the end points.”

The article goes on to say that convenience is increasingly important to participant enrollment and retention, especially those in rare disease clinical trials. The expectation from participants and physicians is for sponsors to consider convenience in trial designs following the pandemic. Investigators in many countries have predicted an increase in these patient-centric trial features, including use of in-home nurse visits.

In-Home Trial Activities

The article states that in December 2019, only 38% of pharma sponsors and CROs were expecting virtual trial designs to be a major part of their portfolio with 48% expecting to run most trial activities in participants’ homes. Flash forward one year later following the onset of the pandemic, 100% of sponsors and CROs now have virtual trial designs with 89% expecting to run many trial activities at home.

Further, there are trends that point to heavy investment by CROs in the partner ecosystem necessary to scale decentralized trials, including the purchase of technology innovators and mobile and home health nursing providers. Biopharma leaders and CROs will need to decide how best to scale these approaches and which ones are better to develop in-house or source from partners.

The H Clinical View

While it looks as if decentralized and hybrid trials can help improve patient experiences, along with increase trial participant enrollment and retention—sponsors and CROs are now understanding the challenges to scale the necessary capabilities into their respective portfolios. While much focus remains on technology, it is extremely resource intensive to stand up the logistics infrastructure and thousands of GCP-trained home health nurses organically. As the leader in decentralized clinical trial support in Latin America, H Clinical is a strategic partner that empowers sponsors to reach and retain more patients to participate from the comfort of home.