White Papers

DCT Planning Checklist: Your Guide to Ensuring a Successful Decentralized or Hybrid Trial

Even before the COVID-19 pandemic spotlighted the benefits of decentralized clinical trials (DCTs), their use was becoming more commonplace. After witnessing the ability of DCTs to rescue a number of clinical trials that were in jeopardy as a result of participants being unwilling or unable to safely travel to clinical sites, more sponsors and CROs are taking note of how a mobile approach could benefit their trials.

Decentralized Trials Are Better Understood, But 5 Misconceptions Persist

Even though decentralized clinical trials (DCTs) have existed for almost 20 years, many sponsors and CROs hesitated to employ them for a variety of reasons, including discomfort due to a lack of familiarity. But the COVID-19 pandemic changed that.

The FDA Steps Up Pressure on Sponsors to Increase Diversity in Clinical Trials: How Decentralized Trials Can Help

The FDA has been advocating for increased diversity in clinical trials for decades but, by its own account, little progress has been made and certain groups remain woefully underrepresented in many studies. But could we now be at a turning point where talk about increasing diversity and inclusiveness translates into action and real change occurs? All indications point to “yes”, with the FDA issuing a second set of guidelines for how study sponsors can increase racial and ethnic diversity in clinical trials.

How Sponsors and CROs can Fully Benefit from the Permanent Shift to Decentralized Clinical Trials Brought About by the COVID-19 Pandemic

To aid sponsors and CROs in fully realizing the benefits of decentralized clinical trial methods moving forward, this whitepaper extracts the lessons learned from the pandemic and their implications for clinical trials now and in the future.