Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
If clinical research were managed like a business, clinical sites would be rewarded for meeting or exceeding patient enrollment targets. But the issue is more complex for both ethical and operational reasons. Some research sites, even poorly performing ones, are appropriately coddled in the service of larger scientific or marketing objectives. And any elevation of a few strong research sites carries the risk of an implicit second-class citizenship for the other sites.
So while most sponsors have done nothing, at least four large pharmaceutical companies and one major contract research organization (CRO) have formal programs to elevate a few sites into preferred status. The efforts function as research versions of frequent flier programs run by airlines, with the main goal being to foster loyalty in a crowded marketplace.
Preferred sites are rewarded with a higher volume of trials. For sponsors, the main criterion for picking preferred sites is scientific excellence. Sponsors also seek especially well-trained investigators, a proven ability to tap into large patient populations, and rapid study startup.
Peter DiBiaso, newly installed as senior director of clinical planning and performance at Vertex Pharmaceuticals, says such relationships are not necessarily contractual or exclusive. The network itself can enlarge and contract in size according to the company’s research program.
On a global scale, elite sites can easily require the labor of two full-time sponsor personnel in addition to the time of regional affiliates near the partner sites. The expectation is that strengthening sponsor-site relations will help build capacity in key countries and institutions, as well as raise the number of investigators who participate in follow-up studies. Theoretically, a preferred site could already be planning for later studies when competing opportunities emerge.
As DiBiaso points out, tightly knit sponsor-site partnerships could, in theory, reduce upfront education and training by virtue of site familiarity with a company’s standard operating procedures (SOP), data provision needs, and other training.
For the sites themselves, such programs also hold out the possibility of truly collaborative relationships with sponsors. Rather than impersonal and transactional ties, preferred sites can enjoy a sense of ownership in studies and pride in being part of scientific advancement through participating in protocol design.
Sponsors generally do not provide additional funding to preferred sites. But they could consistently support sites with subject recruitment and retention materials to help investigators in their relationship with patients, says DiBiaso.
Culling Low Performers
Quintiles, meanwhile, has its own preferred partnership program that currently engages three large institutions in the U.K., U.S. and South Africa and targets operational inefficiencies. The goal is to boost physician interest in clinical research and place at least 40 studies per year at each location, according to Adam Chasse, Quintiles’ global head of prime sites.
One large U.S.-based pharmaceutical company confided that its preferred network currently includes ten sites in seven countries. Those sites are located in Asia, Eastern Europe, South America, Latin America, and North America. The sponsor stripped two additional academic sites of their preferred status when internal bureaucratic delays affected study startup.
The surviving preferred sites are being rewarded with an average of ten studies per site each year, up from four projects when the program began. About half of all studies offered are accepted, a remarkable ratio given that the sponsor company often has several studies for the same therapeutic area running concurrently.
In 2007, GlaxoSmithKline also started focusing its clinical trial activities within a narrower universe of sites to “reduce complexity,” says company spokesperson Melinda Stubbee. Forty nations comprise the current R&D country footprint. For each therapeutic area within each country, GSK has a three-year strategy regarding how to create “high-performance clinical trial hubs” through training of its employees and enhanced investigator relations. These strategies, she says, have “improved the quality and speed of our studies while reducing overall costs.”
The success of preferred partnerships may well depend on the cooperation of CROs and other study partners who regularly communicate with investigators and staff. Companies taking this approach also need to simultaneously broaden their base of new clinical research sites, says DiBiaso: “There’s a commercial and operational risk to relying too heavily on too few sites.”
Preferred site ties also require more adroit, nimble trial portfolio planning, something that can be difficult for sponsors running three trials per year or 300. The inability to coordinate and anticipate a sponsor firm’s needs for clinical sites on multiple time tables could leave sites with nothing to do—and thus make preferred site relationships little more than empty verbiage. Over the long haul, that could undermine the industry’s efforts to establish deeper and closer ties to the research community.