Traditional, Hybrid, or Decentralized: What Actually Works?

Every indication and every patient is unique. So, trying to develop a therapy that will safely and efficiently treat patients while considering the parameters of the therapeutic indications as well as the patient’s needs is a daunting task. Yet somehow, year after year, researchers manage to develop therapies and treatments that improve the lives of millions across the globe.

The final hurdle is to prove that what works for a few, works for many. This requires data indicating that the treatment demonstrates efficacy in people or varying ages, ethnicities, genders and even socio-economic backgrounds.

It is at this hurdle that many clinical trials in phase 2 and 3 either stumble or fail entirely. Over 80% of all trials are delayed and 55% are terminated due to low recruitment, enrollment and high attrition rates.

A combination of factors can lead to this: overly specific inclusion/exclusion criteria can lead to protocol amendments being required, a failure to demonstrate efficacy and safety which can stem from inadequate patient education and patient dropout, and, of course, the struggle to actually recruit and retain patients throughout a study.

These challenges highlight how critical clinical trial design can play. Sponsors have to consider each of these factors when determining what approach will allow them to best meet their study endpoints and objects, while simultaneously ensuring that sufficient patient recruitment, enrollment and retention levels are reached and maintained. And while one approach may work well in one therapeutic area, it can create barriers in another.

It is clear that selecting the right trial delivery model has become an increasingly important consideration during study design.

Trial delivery decisions can make or break study success. Complete the form below to read the full article and learn how the right study model can improve recruitment, retention, and overall study success: