No Place Like Home: How To Make Decentralized Clinical Trials A Win For Patients, Sponsors & Investigators

Nearly three out of four biopharmaceutical firms modified traditional protocols to adopt a form of decentralized studies – also known as virtual or siteless trials – in an effort to keep drug development programs on course during COVID-19. The strategy proved successful. Now, having gained a foothold in the biopharma industry, decentralized trials are poised to play a major role in drug development post-pandemic.

To execute decentralized research strategies, sponsors are turning to an integrated supply chain solution known as Direct-to-Patient Services. Direct-to-Patient Services allow patients to participate in clinical trials from their homes by providing them with study drugs and care where they live. This eBook focuses on the integral role Direct-to-Patient Services play in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

INTRODUCTION

Decentralized clinical trials were on the rise for years before COVID-19, but it was their success in keeping drug development programs on course during the pandemic that won these studies a new leading role in mainstream clinical research.

Decentralized trials emerged as a remedy when COVID-19 shutdowns plunged the biopharmaceutical industry into emergency mode. Drug makers faced the prospect of watching costly clinical trials grind to a halt as the pandemic prevented study patients from accessing clinical supplies and care – either due to closed investigator sites or patients’ reluctance to visit open sites and risk possible exposure to the virus.

In an effort to keep their drug development programs on course, nearly three out of four biopharma firms modified traditional protocols to adopt a form of decentralized studies, also known as virtual or siteless trials.¹

To execute their decentralized strategies, sponsors are turning to an integrated supply chain solution known as Direct-to-Patient Services. Direct-to-Patient Services enable patients to participate in clinical trials from their homes by providing them with study drugs and care where they live.

In addition to the critical role decentralized studies have played during the pandemic, these patient-centric trials are earning praise thanks to the benefits they offer for patients, investigator sites and sponsors alike. Patients favor these studies because they gain access to novel therapies and customized care without leaving their homes. Investigator sites are pleased because decentralized studies make it easier for them to recruit study patients and they no longer have to store clinical and ancillary materials for the duration of trials.

Finally, sponsors benefit from the solutions posed by decentralized trials for longstanding research challenges. By facilitating patient enrollment and improving patient adherence and retention – issues that are central to the success of clinical research – decentralized trials can potentially reduce the length of trials and enable new treatments to reach the market sooner.

So, it isn’t surprising that more than 90 percent of respondents in a mid-2020 industry survey said they expect to see increased adoption of decentralized studies in the long term. Decentralized clinical trials have gained a foothold in the biopharma industry and are poised to play a major role in drug development after COVID-19 is history.¹

The focus of this eBook is the integral role Direct-to-Patient Services play in the execution of decentralized trials, including the options available and when and how to deploy these services for maximum impact.

Decentralized clinical trials have gained a foothold in the biopharma industry and are poised to play a major role in drug development after COVID-19 is history.