New Agreement Helps to Improve Transatlantic Cancer Clinical Research

National Cancer InstituteFor Response to InquiriesFOR RELEASE, Monday, May 19, 1998NCI Press Office, Sabine Steimle, sst@eortc.be

A major step toward improving and speeding up transatlantic cancer clinical research has been achieved through an agreement between the U.S. Office for Protection from Research Risks (OPRR) and the European Organization for Research and Treatment of Cancer (EORTC), Brussels. The Brussels-based EORTC was awarded an International Cooperative Project Assurance (ICPA) in January, 1998.

"Collaboration between the EORTC, other international cancer research groups and the 12 U.S. cooperative groups funded by the U.S. Government's National Cancer Institute (NCI) can now be expanded," said Richard L. Mowery, Ph.D., chief of the Clinical Trials Monitoring Branch of NCI's Cancer Therapy Evaluation Program (CTEP), Bethesda, Md.

For many years, joint trials between the EORTC and NCI-funded cooperative groups were hampered because the OPRR requirements did not apply to EORTC organizations. The ICPA covers the research activities of the entire international group and can be cross-referenced to cover multiple protocols, thus reducing administrative burdens for international and U.S. Cooperative Groups.

"We will avoid duplication of research, and therefore save money and time," said Patrick Therasse, M.D., director of the EORTC Data Center, Brussels. "We consider the ICPA a step further toward improving transatlantic cancer research."

"The ICPA was created to facilitate protection of patient-subjects in international collaborative trials," said Tom Puglisi, Ph.D., director of the Division of Human Subject Protections at OPRR.

Research organizations awarded the Assurance meet the strict regulations of protection required by U.S. legislation and by established international standards, such as the Declaration of Helsinki and the Guidelines of the Council for International Organizations of Medical Sciences (CIOMS).

The Office for Protection from Research Risks (OPRR) was created in 1979 as part of the National Institutes of Health in the U.S. Department of Health and Human Services (DHHS) in Washington, D.C. (the American Ministry of Health). It aims to protect patients enrolled in clinical trials by setting up regulations on review of ethical issues, such as informed consent, justification of risks, safety, and confidentiality.

Patients and investigators on both sides of the Atlantic will benefit from OPRR's International Cooperative Project Assurance (ICPA). It will make recruitment to trials on rare cancers easier and faster. Moreover, the agreement facilitates the harmonization of cancer treatment worldwide and also speeds up its transfer from research into clinical practice.

"As a result patients in Europe and the United States will have access to state-of-the-art-treatment in a much shorter period of time," said Therasse.

In addition, recruitment to so-called mega-trials, including several thousands of patients, will be much easier. Large-scale trials such as these enable investigators to discover small, but clinically significant, differences in adjuvant treatment which will help to improve the survival time and quality of life of today's cancer patients.

The National Cancer Institute (NCI) is the U.S. Government's main agency for cancer research. The NCI's mission is to conduct and support research, training and information dissemination on the cause, detection, treatment and prevention of cancer, and on the rehabilitation of cancer patients. In addition to a Clinical Trials Cooperative Group Program comprising 12 groups nationwide, the NCI's research network also includes Specialized Programs for Research Excellence, Community Clinical Oncology Programs (including Minority Based Community Clinical Oncology Programs), and a variety of other programs which fund clinical research, involving thousands of investigators at approximately 2,000 sites.

The European Organization for Research and Treatment of Cancer (EORTC) is an international non-profit research organization under Belgian Law. It conducts, promotes and coordinates multidisciplinary, independent cancer research through 20 cooperative groups in 300 cancer centers and clinics in 38 countries.