CRAACO, Moving Trials Closer to Patients

For seven years, The Conference Forum has hosted the CRAACO® event, which, as stated on its website, through the collaboration of patient advocates, research physicians and nurses, FDA reps, pharma clinical operation executives, and technology companies has provided many case studies as pathways for industry to follow. The organization has also added a dedicated quarterly newsletter, podcasts, and webinars—all toward the forward motion of CRAACO.

It is no easy feat to get two huge behemoths to join together. Pharmaceutical drug development and healthcare systems are in the same pool of the overall healthcare industry. Treating people with approved therapies and medicines is only 14% of the overall healthcare spend, by some reports, but the overall benefits of medicines clearly cannot be doubted. However, the divide of clinical trials on one hand, and healthcare on the other, is fraught with challenges—data, terminology, process, education, and access.

But at the end of the day, it is the people who need these treatments as options to improve their health; that is the central concern, along with proving the efficacy and safety of the medicines.

It is no surprise that clinical trials, as an industry, has turned toward patient centricity, leaving the word “subjects” behind as too antiseptic and separating the person from the trial. “Patients,” for some, is too broad of a terminology, and most agree that “participants” is the best term to describe a person in a clinical trial. This is discussed in a recent podcast with executives from SMO Panthera Biopartners.

In a separate podcast, Christine McSherry and Mindy Leffler, the co-founders of the CRO Casimir, acquired in March by another CRO, Emmes, talk about the true meaning of patient-focused drug development. Though heart-wrenching, the two describe how genuine patient centricity can be achieved in clinical trials, when access to investigational therapies is the only real option for those patients with diseases that give them so little time.

In our lead feature this month, the topic of CRAACO is explored more toward the data piece of the puzzle. Not a bad place to start for researchers and health professionals, in the EHR. But the end story will always be the people.