Given the growth in electronic medical records, online patient forums and sophisticated data analysis techniques, why is locating, randomizing and maintaining clinical trial participants still one of the most cumbersome and time consuming clinical trial tasks? It is not for lack of effort. Nearly every sponsor and CRO has assembled internal focus groups—in some cases multiple groups over the years—to determine how best to solve this conundrum. Some past or current groups have been named Study Start-Up, Rapid Start and Enrollment Focus, but all had the same goal: to efficiently and quickly kick-off a study and enroll patients. However, even with all of the time, energy and money devoted to the issue, finding and randomizing patients remains a challenge for the industry.

Technology used to identify eligible clinical trial participants is improving and will continue enabling better patient recruiting. However, the landscape continues to change as well. One of the more substantial forces is the movement toward personalized medicine and the demands that it will place on the sector.

Smaller and smaller target populations for medicines, by definition, require sponsors and CROs to find needles in haystacks around the world. It will be challenging to locate patients to participate in trials, and it will be expensive to monitor these patients as they are less likely to be geographically clustered together. Sponsors will likely need to look farther and wider to source a statistically significant sample, and this will add time and costs to an already costly process.

In response, sponsors and CROs have developed a number of tools to continue making progress toward lowering costs and improving efficiency of study launch and trial subject enrollment. Some are focusing on technology; some are focusing on providing services; others are focusing on a combination of both. Below are a few of these companies and their approaches to solving the clinical trial participant conundrum.

BioClinica Inc. BioClinica is a specialty clinical trials services provider that improves the development of new medical therapies by delivering expertise and technologies that enhance clinical research data and analytics, worldwide. The company offers industry-leading medical imaging services, enterprise eClinical technologies, patient recruitment and retention, clinical research centers and cardiovascular safety solutions that bring quality and efficiency to every phase of clinical development. In July 2015, BioClinica acquired MediciGroup Inc., a global patient recruitment and retention firm. Medici recruits patients around the world for clinical trials across a number of therapeutic areas, with particular focus in orphan diseases and unique patient populations for hard-to-recruit clinical trials. 

Mayo Clinic. In September 2014, Mayo Clinic and IBM announced plans to pilot Watson, the IBM cognitive computer, to match patients more quickly with appropriate clinical trials, beginning with research studies in cancer. At that time, the chairman of Mayo Clinic’s medical oncology unit said, “In an area like cancer, where time is of the essence, the speed and accuracy that Watson offers will allow us to develop an individualized treatment plan more efficiently so we can deliver exactly the care that the patient needs.”

PMG Research Inc. PMG is an Integrated Site Network of clinical research facilities in the southeast region of the U.S. with locations in North Carolina, Tennessee and South Carolina. The company has extensive experience conducting all phases of trials across a comprehensive list of conditions. PMG’s facility relationships allow it to accelerate clinical trial subject identification and randomization. Since 1979, PMG has worked on over 6,000 research studies for more than 100 customers.

Radiant Research Inc. Radiant is one of the largest clinical trial site management organizations. The company has over 75 investigative sites that it leverages to identify possible clinical trial participants and conduct clinical trials. The services provided by Radiant allow trial sponsors to engage with a large number of sites by entering into only one contact. This avoids time generally spent negotiating numerous site contracts and improves speed of study start-up and randomization. Radiant has access to over 2.5 million participants and has successfully completed more than 12,000 clinical trials.

Synexus Limited. Synexus is a multi-national company dedicated to the recruitment and running of clinical trials at its owned research centers. Synexus operates a global network of 25 dedicated research centers in eight countries—UK, Germany, Poland, South Africa, Romania, Bulgaria and Ukraine—focusing on cardiovascular, metabolic, musculo skeletal, respiratory and CNS trials. In February 2015, Synexus completed a management buyout from Lyceum Capital with the backing of LDC. LDC is a leading private equity company in the UK and is affiliated with Lloyds Banking Group.