The 3 stages of decentralized trial maturity
It is well evidenced that the clinical trials industry is experiencing unprecedented change. Patients are increasingly seeking trials relevant to their specific needs and lifestyles, patient advocacy groups are driving for more representative and inclusive trial processes, and regulators have begun actively advocating for clinical trials that place the research patient at the center of the study.
Decentralized clinical trials (DCTs) offer a way to improve the patient experience, with a growing body of evidence showing that they can offer increases in patient recruitment and retention and faster time to market. The road to mainstream implementation of DCTs has been long but it is increasingly becoming standard practice within clinical trial design; for example, the Heads of Medicines Agencies, European Commission, and European Medicines Agency’s newly published “Recommendation Paper on Decentralized Elements in Clinical Trials” has the stated aim of “facilitat[ing] the use of decentralized elements in clinical trials in the EU/EEA.”
The challenge that sponsors are facing is how to deliver the innovative organizational transformation that this requires, while also meeting the often-competing needs of stakeholders such as the site, ethics committees, CRO partners, and other parts of their organizations. What is clear is that differing approaches to solving this problem have led to an industry landscape that varies in its ability to have a human-centric response to decisions.
For industry leaders, it can be difficult to know how to address this challenge. A framework approach will enable you to assess your organization’s current clinical trial innovation maturity and build a plan from there.