Government Registry of Clinical Trials Necessary, Marcia Angell States in Opinion Piece
"[S]uppressing unfavorable research results is fairly standard practice in the pharmaceutical industry," but with the creation of a public registry of clinical trials, some "abuses" could be eliminated, Marcia Angell, former editor of the New England Journal of Medicine, writes in a Washington Post opinion piece. Currently, drug companies must submit all trial results to FDA, but neither the drug companies nor FDA are required to make them public. FDA could approve a medication based on "a few trials that make it look good, even though other trials may indicate it is not effective," Angell writes. In addition, researchers can set up trials to "make drugs look good," through tactics such as enrolling younger people in trials to test medications for older patients to decrease side effects or comparing new drugs to older drugs administered at lower doses, she continues. Angell notes that drug companies also engage in "data dredging," or sifting through trial results to highlight positive data, often changing the stated purpose and duration of the study in the process. Angell supports the creation of a public registry, which she maintains should contain all trials and should be administered by a "publicly accountable agency," such as NIH.
Before drug companies are allowed to enroll human subjects in trials, they should be required to register the trial, she continues. To avoid any bias in the study design, registration should include "a brief description of the design of the trial, including the kinds of patients to be enrolled, the drugs and doses to be tested, what the new drug will be compared with, the duration of the trial, the endpoints that will be measured and the methods of measurement," Angell writes. She adds that the registry should "identify the main researchers and disclose any financial ties they have to the companies whose drugs they are studying." Angell concludes, "The establishment of a government registry of clinical trials is a good way to begin, but it must be done right" (Angell, Washington Post, 8/13).