NEWS

Initiative to Focus on Boosting Enrollment in Clinical Trials

Charles Marwick

The chronic problem of obtaining sufficient numbers of patients to expeditiously evaluate new treatments for cancer is getting renewed attention. A new collaborative partnership between the public and private sectors has been developed that researchers hope will increase the numbers of participants in early-stage clinical trials and thus speed the advent of new therapies for cancer.

The collaboration includes the National Institutes of Health, the Foundation for the National Institutes of Health (a group that builds relationships with industry, academia, and philanthropy), a number of advocacy organizations, and the pharmaceutical industry. The move has the blessing and some funding from the Department of Health and Human Services, which oversees NIH and the National Cancer Institute.

The new venture plans to provide up to $6 million to be awarded to between 6 and 8 cancer centers that will design and implement new approaches aimed at increasing the number of the patients participating in phase I and II clinical trials. Currently only 3% to 4% of eligible adult patients participate in such trials. These trials evaluate such factors as safety and efficacy and determine dose-response levels, evidence that is necessary before mounting the larger clinical studies needed for drug approval by the U.S. Food and Drug Administration.

Ellen Sigal, Ph.D., founder of Friends of Cancer Research, an organization that aims to mobilize public support for research in cancer, played a role in helping to bring the collaboration to fruition. "We can only accomplish this by working together," Sigal said. "No single person has all the answers."

The step was announced with considerable fanfare by HHS Secretary Tommy G. Thompson at a meeting held at the NIH on July 22. Thompson described the move as a public–private partnership that will speed progress toward new cancer therapies. He predicted that increasing the numbers of patients participating in early-phase clinical trials will shorten the time it takes for promising therapies to move from the laboratory bench to the patients’ bedside.

The pharmaceutical industry will also take part in this collaboration. The five drug companies participating in the project are GlaxoSmithKline, Aventis, Bristol-Myers Squibb Company, Eli Lilly and Company, and Novartis Pharmaceuticals Corp.

The project "holds great promise for cancer patients," said John T. Kelly, M.D., senior vice president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, the drug industry’s trade association. He pointed out that there are 68 drugs for lung cancer, 59 for breast cancer, 55 for colon cancer, and 52 for prostate cancer that are either in clinical trials or awaiting FDA approval. Overall, he said, there are more than 400 new cancer medicines being developed. This, he said, "indicates how vital it is to recruit patients for clinical trials. Our common goal is to promote the recruitment of patients for clinical trials and thus accelerate the development of new medicines for cancer patients."

NIH Director Elias Zerhouni, M.D., said that the collaboration was prompted by the biomedical and scientific developments of recent years. There are, he said, an enormous number of new biological targets that have been identified and that offer the potential of cure. "At the same time we are incurring a difficulty in the sense that the amount of discoveries we have made is so large that we do not have the translational answer to be able to bring these findings to use as effectively as we would wish," he said.



View larger version (129K):
[in this window]
[in a new window]
 
Dr. Elias Zerhouni

 
NCI Director Andrew C. von Eschenbach, M.D., said he believes that the new partnership will improve the situation. "Together, we will build a bridge that rapidly translates new discoveries into life saving interventions," he said. "Together the government and the private sector will bring new hope and new reality to accelerate this process so that patients who today are destined to suffer and die from this disease will not do so tomorrow."



View larger version (116K):
[in this window]
[in a new window]
 
Dr. A. C. von Eschenbach

 



             
Copyright © 2002 Oxford University Press (unless otherwise stated)
Oxford University Press Privacy Policy and Legal Statement