Three Pillars to Transform Clinical Trial Design & See Exponential Improvement in Patient Participation Rates

Three Pillars to Transform Clinical Trial Design & See Exponential Improvement in Patient Participation Rates

It is not new news to any clinical trial professional that more than 80% of clinical trials do not meet their patient recruitment timelines. Furthermore, up to 50% of research sites fail to enroll even one patient. How can clinical trial design be transformed to change this situation? How about 1) be transparent, 2) pay for everything, and 3) treat patients like they are guests at a five-star resort.

Well, although seemingly an exaggerated and unrealistic approach to improve clinical trial patient enrollment and retention during clinical trials, author Andrea Wilson Woods taps into what is a growing “patient-centric” movement within clinical research. Making it better for the patient so that they can participate in clinical research could improve results. What follows is a summary of the three proposed rules, as reported in Oncozine.

Transparency

The author worked on a five-year clinical trial at UCLA that ended in 2007. The results of the trial were not released for a decade! The participants in the intervention group want to know the outcome of the trial. When patients commit to something big like a clinical trial, why wouldn’t they be notified of the results? Why not take them on as partners and share all with them?

Pay for Everything

Yes, how about making it easy for patients to participate. Cover not just the costs of the drug, but also transport, lodging, childcare, etc. It is commonsense and makes sense. Right now, most Americans have enough financial stress. In many cases, people can’t afford to participate in a study, even if they would like to. Why not change this?

Treat Patients like they are Staying at Five-Star Resort

Rather than being treated like a number (in some cases, that is how we feel even as standard patients in leading health systems), the sponsor/site should treat patients as if they are staying in a top-notch resort. And why not, without the patient, there will be no results and no study. This experience would come down to A) Outstanding Service, B) Amazing Comfort, and C) Delightful Amenities.

What is the Outcome

Well, the author suggests trying to meet these objectives, even half-way, and patient enrollment and retention rates will be markedly higher, leading to fewer delays involved with clinical research. After all, patients would be the biggest proponents of spreading the word about this new type of trial—“they would tell everyone.”

As it turns out, the patient is at the nexus of the clinical trial, not necessarily the sponsor, site, or the investigator. Perhaps the investigator (doctor) could realize the most important thing about a clinical trial: that without patients, there won’t be anyone for the research.