maceutical research member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) (2006) reached $39.4 billion in 2005, up from $2 billion in 1980.
In recent years there have also been increasing investments in the synthesis of the available clinical evidence in the United States, for example, with the establishment of AHRQ’s Evidence-based Practice Centers (EPCs), as well as private-sector activities (Atkins et al., 2005a; Garber, 2001). Appropriations for health services research made to all federal agencies—AHRQ, the NIH, the Veteran’s Health Administration, the U.S. Department of Defense, the Centers for Medicare & Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention—has now reached approximately $1.5 billion annually. However, research on clinical effectiveness receives only a small part of that investment (IOM, 2007a). In general, vastly more funding is available for primary medical research than for the synthesis of the available evidence.
A number of public- and private-sector organizations are involved in the collection, analysis, and dissemination of clinical effectiveness information. In addition to the NIH and the private-sector groups that fund primary research, many other organizations are involved in assessing that information and synthesizing it in ways that inform decision making. Some of the many organizations that conduct these activities are described below.
In deciding whether particular drugs or devices should be allowed to enter the market, the FDA plays a central role in assessing clinical efficacy data. The FDA consists of eight offices. One of these, the Center for Drug Evaluation and Research (CDER), evaluates the safety and efficacy of all new drugs before they are sold on the market and monitors the safety of drugs after they have been approved. Other offices within the FDA include the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health.
In deciding on drug approvals, the CDER relies on advisory committees to obtain outside opinions and advice. Advisory committees review the evidence and provide input on new drugs; major new indications for previously approved drugs; and requirements for new drugs, such as boxed warnings on drug labels. The CDER takes advisory committee recommendations under consideration, but they are not binding (CDER, 2007). The CDER follows many of the same procedures when it evaluates its portfolio