About CERTs
Annual Report Year 1
Steering Committee Letter | Introduction | The CERTs Program | Year 1 Progress | Year 2 and Beyond | Conclusion | CERTs Organization | CERTs Projects | Publications
Letter from the Steering Committee
Dear Fellow Citizens:
Neither patients nor their caregivers should have to guess which therapies are the best, or live in fear that a mistake was made in treatment. This is the basis of the CERTs program.
The U.S. system of developing and marketing medical products has produced great benefits. This system requires that adequate, well-controlled studies show that products are safe and effective for their intended use.
The system has some drawbacks, however. For example, to meet the requirements for marketing approval, clinical studies of a new therapy may have a very narrow focus—testing it, say, only in male adults. Information often is lacking about how it may work in other groups.
Further, studies may not test medical products in combination with other therapies often used by the same patients, with occasionally fatal results.
Once approved, drugs and devices often are used for purposes other than those for which they were approved. Sometimes these uses are supported by studies, but not always. It is hard for caregivers and patients to find information about such uses, except through personal experience, which can be risky.
Finally, some side effects of medical products emerge only after they have been approved for sale, when large numbers of people begin to use them. The systems used to capture these events may not be as effective as they could be.
No wonder caregivers and patients in the real world are left with doubts about therapies.
The CERTs program fills several gaps. It aims to answer important questions that have not been addressed. It provides its results, positive or negative, for all to see. It sets out to develop a learning curriculum for current and future caregivers. Finally, it represents a major step toward giving people the information they need to make the best choices possible.
The participants in CERTs—government agencies, academic organizations, managed-care organizations, drug and device companies, practitioners, commercial research groups, and consumer groups, among others—have voluntarily committed to seeking answers together, putting society's interests first.
People of all ages deserve the benefits of the CERTs program. We are committed to establishing a national network of centers that will investigate and educate. We hope that this collaboration will improve health for us all.
—Hugh Tilson, MD, DrPH (chair); Lynn Bosco, MD, MPH;
Robert M. Califf, MD; William H. Campbell, PhD; Lisa Egbuonu-Davis, MD;
Linda Golodner; Peter Honig, MD, MPH; Judith M. Kramer, MD, MS;
Richard Platt, MD, MSc; Wayne A. Ray, PhD; Kenneth G. Saag, MD, MSc;
Marcel Salive, MD, MPH; Brian L. Strom, MD, MPH;
Karen Williams; Raymond L. Woosley, MD, PhD