WASHINGTON, DC—The Department of Veterans Affairs health care system provides both benefits and obstacles for anyone looking to conduct pharmaceutical trials in their patient population. While this patient population is one of the largest in the nation, challenges include navigating the bureaucracy, contacting individual VA facilities, and tracking down VA physicians interested in working on the trial. In the field of cancer research, a solution has emerged: VA’s Clinical Oncology Research Network (CORNET). Established in 1997, CORNET is a network of VA hematologists and oncologists working in facilities across the country.

They have organized to provide a VA system for industry cancer trials, and to help individual investigators with new research ideas partner up with industry sponsors.

Benefits to Industry

In the late 1990s, VA was a promising site for clinical cancer trials. Pharmaceutical companies looked to VA as a potential partner in new clinical trials where VA had a large amount of the relevant patient population. However, to do so, each company would have to approach VA facilities individually, sign multiple contracts with each facility, and spend considerable time and effort to contact VAphysicians. Dr Monica Spalding, a clinician working out of the Buffalo VA, originated the idea of a central location to act as an intermediary. Dr Spalding helped create CORNET, running it out of her VA location in Buffalo. The network’s primary function is to organize pharmaceutical sponsored, multi-centric trials within VA, as well as supporting investigator-initiated studies. In 2003, CORNET headquarters moved to the Minneapolis VAMC and is now directed by Dr Vicki Morrison, a clinical researcher specializing in oncology. “Most if not all VAs that provide oncology care—their physicians have memberships most often in one of the three large NCI sponsored cooperative groups. People will have cooperative group trials open at their sites. The function of CORNET was to bring in some additional studies that could be offered to the patients,” explained Dr Morrison “We provide a clear mechanism for these pharmaceutical sponsored trials [to find] potential implementation at VA sites. And we provide a mechanism in support for investigator-initiated trial ideas to be taken to industry for potential support as well as potential accrual across the VA system.”

The strengths of the network in terms of advantages to industry are considerable. CORNET has the capability to do screenings at multiple VA sites much more quickly than industry could. The network is also set up with a single contract for however many facilities a trial involves. “One of the big advantages of CORNET is that it can be fairly flexible,” Dr Morrison explained.

Benefits to Investigators

For individual investigators with new ideas, CORNET provides a direct link to potential industry partners in addition to significant support during the trial process. “CORNET can work to collect regulatory paperwork and work with an individual investigator in terms of developing case report forms,” Dr Morrison said. “We also can compile the clinical trial report data, collect other regulatory data such as adverse events, initial IRB approvals and annual renewal reports.”

Having CORNET support makes an investigator-initiated idea more attractive to pharmaceutical companies, since CORNET can help run the study across multiple VA sites. Thus, accrual is finished in a timely manner. For example, Dr Balkrishna Jahagirdar, a clinical researcher at the Minnesota VA, had an idea involving the use of oxaliplatin and docetaxel in treating recurrent and/or metastatic squamous cell carcinoma of the head and neck. Through CORNET, Dr Jahagirdar approached Sanofi-Aventis with his clinical trial concept. In collaboration with Sanofi-Aventis and CORNET, he was able to develop the Phase 2 protocol and get it activated at multiple VA sites across the country. Ultimately, CORNET has helped facilitate between 10 and 15 protocols in the decade it’s been operational, Dr Morrison said.