Specifically, Tufts found that soliciting input from clinical research sites on protocol design, providing payments directly to study patients, sharing their development plans, and providing feedback via quality metric scorecards can help sponsors and CROs mitigate challenges.
Patient recruitment remains the largest challenge clinical research sites face, with more than half of sites saying sponsors and CROs they work with don’t provide sufficient information about the studies they’re working on.
Also posing a burden on sites is the way sponsors/CROs pay them. According to the Society for Clinical Research Sites (SCRS), in 2014 about 65% of clinical research sites had less than three months of operating cash -- a slight increase from 57% in 2012. On average, sites also pay for patient visits as a study rolls out, but the sites don’t typically receive payment from sponsors/CROs until about five to six months after the work is completed.
And to help guard against unpredictable site performance, sponsors and CROs have reduced the average number of randomized patients per trial expected of each engaged investigative site, according to Tufts, though this has resulted in an unintended consequence of limiting sites’ ability to operate efficiently.
Participants in the roundtable said they are looking to solicit more input from investigative sites to guide study planning and execution; incorporate anticipated changes in the site landscape, such as the integration of clinical research into patient care at large health institutions; and establish new relationship support mechanisms.
Tufts gives the example of having a medical monitor available 24/7 to answer questions when patients are at an active trial site can help sponsors and CROs ensure strong site performance.
New Paradigm
A CRO that conducts clinical trials globally also suggested to Tufts that strategic site relationships are creating a “new paradigm” in site management because strategic partnerships between sponsors and CROs are adding to CROs’ responsibility to select and manage sites.
“Sites that want to build their business over the medium- to long-term are responding by adopting best practices, including better management of data and investing in their relationships with CROs,” Tufts notes. From a CRO’s perspective, criteria that make a site suitable for a strategic relationship include:
- The ability to solve problems quickly, provide effective protocol and technical training;
- Ensure clinical trial materials and investigational drugs arrive at the site on time; and
- Ensure that the clinical research associate is kept abreast of the protocol and therapeutic area.