CRO and AMC Collaboration

It's true. What many have pitted as perennial foes in the battle for industry-sponsored drug trials—with the Academic Medical Centers (AMCs) as underdog—is changing. What history may show in regard to the use of AMCs in industry-sponsored drug trials remains to be seen. But in just the past few years, there has been a recent upswing among CROs and AMCs that are collaborating. This requires an adaptation to business relationships on both sides of the fence, but is occurring to meet the needs of the evolving drug development market.

Lisa Henderson

And what are the drivers of collaboration? For the CRO, drivers of collaboration with AMCs may include greater access to specialized expertise for specific therapeutic areas, the ability to take advantage of certain AMC-developed tools, or the opportunity to provide sponsors with additional benefits through expanded access to investigator sites and patients. For the AMC, the ability to be on the cutting edge of drug development remains paramount. For the industry at large, most have recognized that the blockbuster drug is becoming a business model of the past. "The world is realizing it is very expensive to get drugs to market," Josef von Rickenbach, chairman and chief executive officer of Parexel told Applied Clinical Trials.

"In order to develop drugs more effectively, the industry needs to identify where more efficiencies can be gained." He said that the trend toward targeted treatments combined with the constricting health care dollar, means that more fragmented markets don't have the resources to absorb development costs.

In early December, Parexel announced its alliance with the Safe Implementation of Treatments in Stroke (SITS) International, a network of clinical sites specializing in stroke. In a release, the CRO included the following benefits of the alliance to its clients: accelerated study start-up, patient recruitment, and specialized capabilities to execute stroke-related studies on a global basis. "In joining forces with Parexel, SITS looks forward to furthering the growing field of stroke research and speeding the introduction of important treatments to patients," said Nils Wahlgren, MD, PhD, and Chairman of SITS in the release.

Von Rickenbach, commenting prior to the announcement of the alliance, told us that the CRO intended to continue its relationships with AMCs in many forms. Specifically of the SITS alliance, von Rickenbach noted that it "highlights an approach we are applying, a more constructive way we have developed to work with academia." Parexel has had numerous successful relationships with AMCs over its 25 plus years. "The collaborations between CROs and academic medical centers have waxed and waned over the past couple decades," von Rickenbach noted. "But the number of these relationships has grown in the past few years." The company will continue to identify strategic opportunities to create alliances with effective AMCs.

Cutting-edge research

"In order for us to keep our edge as a tertiary medical center, we have to do research," said Janis M. Orlowski, MD, senior vice president and chief medical officer, Washington Hospital Center (WHC) located in Washington, DC, and part of the MedStar Health System.

FDAs Angle

"We are looking to partner into higher impact, high quality trials," Dr. Orlowski told Applied Clinical Trials. "Our investigators have done a study here, one study there. With Quintiles, they bring us a portfolio of studies they are working on, and let us choose from that portfolio." Orlowski maintains this is different from the investigator-initiated or industry-initiated trials where "you're either in or you're out." Orlowski was impressed with both the quality of investigators that would be involved as well as the quality of the clinical research Quintiles was doing.

Oren Cohen, MD, senior vice president of clinical strategies at Quintiles, and consulting professor of medicine at Duke University School of Medicine, believes the benefits of collaboration for the AMCs with which Quintiles partners—such as the MedStar Health System—do have a different value, as Orlowski mentioned. "Clinical research can raise the profile of the institution, and a lot of partners tend to find attractiveness in the steady stream of cutting edge clinical studies we can provide."

In regard to the types of trials CROs and AMCs are currently involved with, Cohen noted that as early as five years ago, CROs were getting knocked for just being contracted by pharma for the "me-too" drugs. "Now, that's changed dramatically," said Cohen. "We are involved in biologics, immunology, cutting-edge cancer treatments...and that is attractive to the AMC as well."

Orlowski is looking forward to using the connections that Quintiles has to get the studies the hospital needs to support its community, as well as its internal research desires. "We ask them to keep their eye out for a certain type of study (WHC has a high interest in cardiology) and they have the ability to look for these studies."

Although its partnership with Quintiles is only a little over six months old, Orlowski reports she is very happy. "We have other relationships with pharmaceutical companies, and we have worked with other CROs, but not as a primary research site," she said. "It will be interesting to see how it develops."

Community investments

"I call us a 'megasite' but I don't think Quintiles uses that term," said Neil J. Weissman, MD, president, MedStar Research Institute and professor of medicine, Georgetown University. MedStar Research Institute is the centralized clinical trials and medical research services function of MedStar Health. MedStar Health includes WHC, as well as Georgetown University Hospital, National Rehabilitation Hospital also in DC, Franklin Square Hospital Center, Good Samaritan Hospital, Harbor Hospital, and Union Memorial Hospital in Baltimore. As such, they could be considered a megasite in the case of subject recruitment, where as Weissman explained, Quintiles could go to 50 sites and enroll 10 people, or go to five sites and enroll 100.

MedStar Research Institute (MRI) was initially formed in the 1960s under a different name and was the research division of the WHC. According to Weissman, 10 years ago when the MedStar Health System was formed from the merger of two previous systems, MRI grew fast. "Academic medicine and community medicine came together in our diverse hospital system," says Weissman. "It gives us the potential to tie together translational research from lab bench to bedside to community." Like other AMCs who noticed the need to centralize certain aspects of the clinical trial initiation, MRI provides one IRB, one place for contracts, investigator support in terms of personnel, training, budgets, and more. Specific to the success of the Quintiles alliance, MRI is providing a medical scientific director and project manager dedicated to Quintiles' studies.

The ties to community that exist with the AMCs can't be overemphasized in the new model CRO–AMC collaborations. Cohen cites a March 2008 Archives of Internal Medicine article titled "Better Outcomes for Patients Treated at Hospitals That Participate in Clinical Trials" (Vol. 168, No. 6, March 24, 2008, pp. 657-662; http://archinte.ama-assn.org/cgi/content/abstract/168/6/657 links to the abstract, you need to purchase one time, full-text access), which presented its supported hypothesis that hospitals that perform clinical trials have certain elements that carry over into better overall care (i.e., patient outcomes) in the community. Cohen called it the "halo" effect in the community.

"We are using our strength as a multisite hospital system to look at novel and innovative ways to develop research. We can bring the clinical investigator and community-based research together," said Weissman. The issue is that what works in the isolated academic hospital setting doesn't necessarily work in the community. Weissman envisions a Primary Care Based Research Model with community researchers bridging the gap on an outpatient basis. As Weissman says, "Clinical research is changing and we need to stay ahead of those changes to be successful."

Lisa Henderson is editor-in-chief of Applied Clinical Trials. She can be reached at lhenderson@advanstar.com