At the annual meeting of the American Society of Clinical Oncology, a large cancer research meeting, which was held in Chicago this week, Merck & Co. (Whitehouse Station, NJ) announced the launch of the Merck Oncology Collaborative Trials Network, a clinical-trial network focusing on the development of Merck drug and vaccine candidates being investigated for the treatment and prevention of cancer. Although the initiative is centered on improving clinical-trial management, it is also important for development and manufacturing organizations that supply clinical-trial materials.

Merck said it is launching the network in response to an April 2010 report by the Institute of Medicine (IOM) that recommended changes to transform the National Cancer Institute’s (NCI) Clinical Trials Cooperative Group, the program responsible for conducting collaborative large-scale cancer clinical trials at institutions and community-based practices in the US and aboard. The review of the NCI’s clinical-trial program was initiated because of concerns by NCI stakeholders, which included clinical investigators, patient advocates, leadership within NCI’s Clinical Trials Cooperative Group, industry participants, and the NCI that “the program is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care,” said the report.

In its statement, Merck noted that according to the IOM report, about half of collaborative cancer studies are never completed due to cumbersome procedures, bureaucracy and poor coordination. The report suggested that collaborative-research approaches could be improved by reducing the number of sites, properly funding research efforts, setting strict deadlines and prioritizing studies. Merck says its new oncology collaborative trials network embodies many of these principles and “could serve as a blueprint for how industry and research institutions can work together more efficiently and effectively to expedite the delivery of innovative cancer therapies to patients.”
Merck’s oncology network site currently consists of 15 sites across North America, South America, Europe, and Asia. Through a proposal and feedback process, the research sites will lead the design and conduct of Phase 0 to IIa clinical studies of Merck’s investigational oncology candidates. Every year, the network will enroll approximately 1200 patients in 30 to 40 clinical trials. These studies will include investigator and company-sponsored trials. Infrastructure to consolidate data, specimen-testing results, imaging-testing results, and patient outcomes is being developed, according to the company. “This approach will lead to more informed, data-driven, and rapid decision-making regarding the efficacy and safety profile of compounds and the utility of biomarkers developed by Merck or its collaborators,” said Merck in it statement.

Although focusing on clinical-trial administration, the network, if successfully executed and indeed becoming a model for improving clinical-trial administration for cancer treatments, as Merck intends, would be important for suppliers of clinical-trial materials as well. Delays and logistical difficulties in clinical trials translate into problems for the supply chain of clinical-trial materials and the development and manufacturing organizations that supply those materials. Oncology therapies are a crucial area of development not only for Merck, but for other drug companies as well. An organized effort by a pharmaceutical company to specifically address problems in clinical-trial administration is valuable for potentially accelerating development in a therapeutic area of critical medical need. But the approach also offers, if successfully executed, the potential for other drug companies to apply the approach to cancer trials and potentially to other areas of drug development. This would be a win-win situation for all stakeholders in clinical trials: the suppliers, the pharmaceutical company, and ultimately, the patient.

[orig. published June 8, 2010]