Clinical Trials and Informatics

The National Cancer Institute (NCI) is reforming its clinical trials program to make both cancer information and the trials themselves more accessible to all Americans.

This new effort, called the Cancer Informatics Infrastructure (CII), will transform the current system over the next two years beginning in fiscal year 1999. As the system evolves, data management techniques in clinical trials will be upgraded and information exchanges among researchers, physicians and the public will be facilitated. CII is expected to greatly speed the application of research discoveries to the daily practice of medicine.

The management and conduct of prevention, diagnosis and treatment studies will be simplified and accelerated. For the first time, all NCI-sponsored cancer clinical trials will have common terminology and reporting requirements, thus increasing the efficiency of conducting a trial and the efficient analyzing and disseminating of results. Common data sets also are intended to reduce the complexity and variety of forms that doctors and patients must complete. The CII will use the best technology available to protect the privacy of personal cancer information.

Cumbersome paper-based systems of collecting data for multi-center studies will give way to electronic communication, linking sites of care (hospitals, doctors' offices and clinics) with the secure, research databases of investigators. For example, the physician will complete simplified, computerized forms, submit them, and -- if the physician and patient meet certain standards and criteria -- the patient will be entered into the clinical trial, receive the therapy and remain in the care of his or her physician.

Industry and the academic sector will play a principal role in building the CII. NCI will promote communications among participating organizations, help develop appropriate standards, and fund initial projects. But the infrastructure will expand significantly as cancer centers, physicians in private practice, managed care organizations, pharmaceutical companies, patient advocates, and consumers work together to put in place the actual standards and technology. NCI has requested $20 million in fiscal year 1999 for this effort.

At the same time, NCI and the U.S. Food and Drug Administration are modernizing information links and establishing standards that will allow collaboration and sharing of results with researchers in North America, Europe, and Japan. An agreement has been established between the U.S. Office of Protection from Research Risks and the European Organization for Research and Treatment of Cancer to accelerate trans-Atlantic cancer clinical research. It will make accrual of patients to trials faster, help harmonize international collaborative cancer treatment research, and speed transfer of knowledge from research to clinical practice.

CII will help patients, families, at-risk individuals, and health professionals learn about clinical trials and where they are being conducted. By using a computer, patients and their oncologists can determine treatment options and clinical trials for a patient's specific cancer.

The CII will provide easy access to information on current cancer research opportunities, new research results, and availability of clinical trials in the areas of diagnosis, treatment and prevention. As a key part of this initiative, NCI has begun expanding and modernizing the Physicians Data Query (PDQ), its widely used cancer database, and has developed a comprehensive clinical trials Web site (http://cancertrials.nci.nih.gov), which is designed to help the public find clinical trials information quickly and easily.

The CII will use the World Wide Web to disseminate information and facilitate enrollment of patients on clinical research studies. It also will reach more Americans with vital cancer information through a variety of mechanisms, including telephone, fax, and printed media to provide the greatest access possible.

For more information about cancer visit NCI's Web site for patients, public and the mass media at http://rex.nci.nih.gov or NCI's main web site at http://www.nci.nih.gov.