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Alternative Medicine in Cancer: Opening Doors to Research
NCI's Best Case Series Program

WHAT IS THE BEST CASE SERIES PROGRAM?

If you are an alternative medicine practitioner who treats cancer patients, the Best Case Series Program is your opportunity to share your successes and have them evaluated by a panel of experts in both conventional cancer therapies and alternative medicine. Approaches that show solid evidence of effectiveness may undergo further study with support from the National Cancer Institute (NCI) and/or the National Center for Complementary and Alternative Medicine (NCCAM).

The NCI is committed to finding innovative, promising therapies for people with cancer. In 1998, NCI established the Office of Cancer Complementary and Alternative Medicine (OCCAM) to support promising research in complementary and alternative medicine related to cancer diagnosis, prevention, and treatment.

The OCCAM communicates with the public, the complementary and alternative medicine (CAM) practitioner community, and the oncology community about cancer research involving CAM. It also develops NCI's CAM agenda, and serves as NCI'S liaison with the NCCAM. Both NCI and NCCAM are part of the National Institutes of Health (NIH) in Bethesda, MD. The OCCAM operates the NCI's Best Case Series Program.

The Best Case Series Program is focused on treatment approaches used for patients with quantifiable disease and is designed to evaluate evidence of tumor shrinkage. However, NCI is interested in approaches that improve quality of life as well. The OCCAM would be glad to discuss a Best Case Series review of data for these approaches on a case-by-case basis.

An unbiased, expert panel of advisors will review the data presented in a Best Case Series. The 15-member panel, called the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM), is composed mainly of non-federal members, including medical and surgical oncologists, an oncology nurse, CAM specialists, a statistician, epidemiologists, a patient advocate, a radiologist, and other medical and scientific experts. Based on the efficacy shown by the data presented, the CAPCAM will advise the director of the NCCAM on whether and how additional research should be supported. The director of the OCCAM also uses the results of the Best Case Series reviews in developing NCI's CAM research priorities and funding proposals.

Development of effective cancer therapies requires uncompromised standards of evidence. Evaluation of CAM research is no exception. NCI has expanded its support of CAM research, and has awarded many high-quality CAM-related research projects. Studies include: the effects of a nutritional regimen on pancreatic cancer, shark cartilage for advanced cancers, green tea compounds for precancerous skin lesions, and studies of stress and pain management to enhance the quality of life for cancer patients.

THE PROCESS

PRESENTING A BEST CASE SERIES TAKES THREE STEPS:

1. Submit required documentation.
   
   Contact the OCCAM for a detailed listing of the elements required for each case report. OCCAM staff will help you determine if you have sufficient data on at least 4 or 5 patients for a Best Case Series or if it is necessary to collect more information. For each patient, you will be asked to submit a Case Report, including:

• Clinical history-patient's signs and symptoms, detailed treatment history, and a statement of any other treatment the patient received before, during, and after the CAM therapy.
• Copies of the pathology reports.
• Copies of medical imaging reports (e.g., x-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI). ultrasound scans).

2. Submit pathology and radiology materials.
   
   Once the paper documentation submitted in Step 1 is complete, the OCCAM will request radiology films and pathology slides for review. An NIH Clinical Center pathologist and radiologist will review the materials.
   If the case is rejected, you will be informed and given the reason for the rejection. If a minimum of 4 or 5 cases are complete and accepted, you will be scheduled to present your Best Case Series to the CAPCAM.
   
3. Present your Best Case Series to the CAPCAM.
   
   The CAPCAM meets twice a year, in early June and early December. Travel and accommodations for practitioners presenting a Best Case Series to the CAPCAM will be paid for by the NCI.

VIDEOTAPED PATIENT INTERVIEWS

Practitioners may submit videotaped interviews of patients whose cases are part of their Best Case Series. Videotapes should be sent only after a Best Case Series has been fully reviewed and scheduled for presentation to the CAPCAM.

Videotapes are optional and will not take the place of the required written documentation and pathology materials. Contact the OCCAM for more information on videotape requirements.

ANSWERS TO YOUR QUESTIONS

What are the potential benefits of presenting a Best Case Series to the CAPCAM?

• Feedback on the strengths and limitations of the data presented.
• Recommendations for further research.
• Broadened awareness of your therapy's effectiveness among the clinical research community.
• Successful approaches may undergo further study with support from the NCI and/or the NCCAM.

What if my expertise is as a clinician, not as a researcher?

When you contact the OCCAM, you will receive a detailed description of the requirements for completing a Case Report. OCCAM staff can answer any questions you have about the requirements.

Can I submit a Case Report for a patient who has received other therapies?

We recognize that many patients who use alternative therapies have received conventional therapies as well. Prior treatment is not a problem for submitting a Best Case Series. In your submission, please note all treatments the patient has received and provide contact information for any other healthcare practitioners the patient was seeing before, during, or after your treatment. You will need to show that there was a biopsy-proven diagnosis of cancer after any prior treatment was completed, and that the alternative therapy had a measurable impact on the disease. In order to determine if the effects on the tumor are due to the alternative therapy under study, the patient should not have received other therapies at the same time that he or she was using the alternative therapy being evaluated. If you claim that the alternative therapy must be given with a conventional therapy for a response to occur, or to reduce side effects, discuss your approach with the OCCAM staff.

What if I only have complete data on a handful of patients?

The Best Case Series Program is an effort to find promising alternative therapies that provide early clues of effectiveness to justify further study. If you have complete documentation of any cases of patients with cancer who have responded to an alternative medicine approach, the OCCAM would like to hear from you. However, all Best Case Series submitted for review by the CAPCAM must have a minimum of 4 completed cases.

What if I don't have all of the information you require?

Contact the OCCAM to find out what data you should be collecting. The CAPCAM meets twice a year and reviews Best Case Series at each meeting. You will have the opportunity to present your Best Case Series once you have collected all of the necessary data and it is found acceptable by the OCCAM. Your willingness to pull the information together for a Best Case Series and present it for scientific review may result in further analysis of your approach and broader dissemination of your therapy to help more patients with cancer.

Will NCI protect my patients' confidentiality?

All efforts will be made to protect patient confidentiality. Documents you send must have full patient identifiers to allow validation of the data. All materials submitted with patient identifiers will be kept in locked files in the OCCAM with limited access. These materials will be viewed by selected NCI and other NIH staff. The patient's name will be deleted from all copies of the documents sent to the CAPCAM members or consultants. Best Case Series presentations to the CAPCAM will be performed in closed session so that patient identifiers may be discussed if necessary. Patient identifiers will not be used in the CAPCAM meeting minutes or any summaries of the session. Although all NCI files are potentially subject to Freedom of Information Act (FOIA) requests, patient identifiers will not be released with routine FOIA requests. Unaltered materials with patient identifiers could possibly be obtained via court order.

Do you accept reports in languages other than English?

Yes. Please inform the OCCAM as soon as possible so that arrangements can be made for translation. Depending on the language and the volume of materials, translation can add anywhere from two to several weeks to the review process.

For More Information or a Submission Package

If your therapy is helping cancer patients and you've got the data to make your case, we encourage you to submit a Best Case Series to:

Office of Cancer Complementary and Alternative Medicine
National Cancer Institute, NIH
Executive Plaza North, Suite 102
Bethesda, MD 20892
phone: 301-435-7980
fax: 301-480-0075
e-mail: ncioccam-r@mail.nih.gov
Web site: http://cancer.gov/cam

NATIONAL INSTITUTES OF HEALTH
National Cancer Institute
NIH Publication No. 01-4808
July 2001

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institutes of Health P616

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