This is the eighth installment in the series (Change is in the Air) on changes coming to the clinical research enterprise that John Neal, CEO of PCRS Network, began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.”
Prediction 8: Fewer study visits will be conducted at research sites.
In Part III of this series I touched on some issues related to this prediction in stating that “As individual patients are identified, prescreened, and in many cases ‘assigned’ to a site, the dynamics behind where study visits occur, and who should conduct them will begin to change.“ Here I want to elaborate, because where, when, and who collects study data is going to radically change study conduct as we know it today.
The changes I see coming that will cause a decrease in the number of study visits conducted at study sites will result not from a single factor but from a combination of many factors. Each will contribute slightly to the changes, but together, they represent a major change to the industry.
In no particular order, the primary factors I see coming together include, but are not limited to,
- increased use of “in-home” visits
- adoption of remote visits (visits conducted at locations other than the Principal Investigator’s (PI) location), and
- virtual visits
My definition of Home visits (HV) are and study visits conducted by a clinical trial professional who goes to where the study volunteer is located, as opposed to the volunteer traveling to the research site. This is not a new idea. In fact, many such visits are already occurring. For the most part, these types of visits have been limited to volunteers who are non-ambulatory. In order to attract volunteers who otherwise would not volunteer to participate in a study because of the inconvenience of traveling to the research site, I believe an increasing number of studies will allow for HVs for ambulatory people.
My definition of remote visits (RM) may vary slightly than others. I define them as those research visits where the visit is conducted at a medical facility location other than that of the PI. These are visits requiring the attention of a medical professional, but that do not necessarily require the PI to be present. This is a departure from the conventional model, and could represent an avenue to access additional volunteers from the patients of Primary Care Physicians (PCP) and Specialists who do not otherwise conduct research.
While speaking with Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) recently, she told me:
My theory is that, for some studies, we could relax a little bit and allow community doctors to complete some of the study visits at their office rather than the PI’s office. It would be better for the patients and would probably increase the speed of enrollment.
Such flexibility by the FDA to modify where and by whom certain study visits occur could open avenues to access volunteers that has been virtually untapped to date.
RVs can be supported by “mobile” research staff, such as having a CRC travel to the PCP or Specialists office for the conduct of the visit. In some respects, that is commonly employed in some Site Management Organization (SMO) models today, although they typically establish the PCP or Specialist as the PI for the studies conducted at their location. In that model, the SMO provides all research related staff and infrastructure, so the PI does not have the burden of adding and managing staff.
The ACRP Online Community is an exclusive platform for the exchange of information, ideas, tools, and resources among ACRP Members.