Gaining Velocity: New site organization aims to solve age-old problem
Velocity Clinical Research recently acquired its first three research sites in the US, including the Clinical Research Institute of Southern Oregon (CRISOR) in Medford, OR and New Horizons Clinical Research (NHCR) in Cincinnati, OH. In December 2018, it also acquired FL-based MD Clinical.
Following the transactions, Dr. Paul Evans has made the move from the UK to the US, joining the Durham, NC-headquartered company as the president and chief executive officer (CEO).
Evans – previously the corporate vice president of global site solutions at Parexel – told us the company’s aim is “to become one of the leading site groups in the world.” As such, Velocity plans to acquire further sites, establish new ones, and continue expanding.
“We obviously aim to scale because a large part of the value proposition of any site organization is to be able to offer operational efficiencies from recruiting large numbers of patients,” he added.
Challenges and opportunities: It's 'all about the last mile'
According to Evans, the site business is on the precipice of several changes that will bring both opportunities and challenges.
“Adapting to the use of EMR with its attendant technology and confidentiality challenges in the Facebook age where everybody is become increasingly sensitized to the use of their personal data; the age of the patient-centric trial where patients become more involved in the research endeavor; the possibility of virtual studies supported by technology,” he noted as among these changes.
However, during his 26 years in the industry, Evans said the one thing that has remained constant is the biggest cause of delays in clinical development: Patient recruitment. This, despite changes in the way sites operate driven in part by advances in technology.
Earlier in his career, Evans saw the emergence of electronic data capture (EDC) and interactive voice response (IVRS), and now, data driven monitoring (DDM), investigator portals, online training, e-consent and electronic medical records (EMR).
“With the exception of EMR you could argue that all of those increase the efficiency and real-time functionality of the clinical trials ‘back office,’ but to sites, they can often look like added burden at a time when protocols themselves have become more complex so the workload is inextricably increasing,” he said.
Read: How to reduce clinical trial site investigator turnover
Consequently, sites have struggled with employee turnover, with many investigators leaving after one or two studies, a challenge that Evans said has also not improved during his quarter of a century in clinical research.
“We should be as concerned with what has not changed as with what has changed because these are fundamental problems,” he added.
“Managing the increasing operational complexity that modern-day clinical studies demand of sites has to result in an increased specialization of site activities and increased focus on how best to resolve site-based inefficiencies.”
Previously accountable for patient recruitment at Parexel and Quintiles (now Iqvia), Evans said he lost track of the numerous approaches used to “get the message out to patients about clinical trials and engage them in the idea of participating.”
“Unfortunately that engagement often did not convert into a randomized patient because it’s what the sites do when they see a patient face to face that counts,” he said. “At Velocity, we will partner with patient recruitment vendors to make sure the last mile is effectively managed to improve the outcome of patient outreach campaigns.”
Key for the company will be having control over patients and data – “too many models aren’t able to achieve that which is why we don’t see them as part of the long term solution,” said Evans.
For patient recruitment, “it’s all about the last mile.”