C an you imagine having access to all of the latest data discovered in any clinical trial performed with a dermatologic drug? If a recent movement that’s been building among American Medical Association members gains the momentum it needs, then all practitioners could have access to valuable data that may guide their clinical decisions differently — and possibly more effectively. The American Medical Association endorsed a policy in June that calls for the Department of Health and Human Services to establish a comprehensive registry for all clinical trials, according to American Medical News. One company, Merck, is already behind the movement. More than 300 clinical trial registries exist; the largest is www.clinicaltrials.gov. However, the AMA wants one comprehensive registry of published and unpublished data from clinical trials. According to American Medical News, an estimated 50% of results from clinical trials are never brought to light. A Willy-Nilly System According to a July 6 Washington Post article, the system of registering clinical trials is anything but consistent. Within the last few weeks, noted the Post, the database ClinicalTrials.gov had a list of more than 5,700 studies that were underway. Of these, only 13% were sponsored by industry, and 55% were sponsored by the federal government (most often by the National Institutes of Health). The article also highlighted the following: • In 2002, only 48% of trials of cancer drugs were registered. • Listing rates for some drugs that treat serious diseases are in the single digits. • Some companies haven’t listed any studies. • In some cases, trials are listed but they don’t include the sponsor or mention the drug that’s being tested. Enforcing a Little-Known Law There’s already a law that requires companies to register trials, however, it’s not enforced — probably because the statute doesn’t give the FDA any authority to levy penalties or come down on violators. Of course, there’s another side to this issue. Researchers are concerned how lay people could interpret — or misinterpret — data, and members of industry are worried about uncovering trade secrets. What are your thoughts about a comprehensive registry? n Larisa Hubbs Executive Editor lhubbs@hmpcommunications.com
Opening the Floodgates
C an you imagine having access to all of the latest data discovered in any clinical trial performed with a dermatologic drug? If a recent movement that’s been building among American Medical Association members gains the momentum it needs, then all practitioners could have access to valuable data that may guide their clinical decisions differently — and possibly more effectively. The American Medical Association endorsed a policy in June that calls for the Department of Health and Human Services to establish a comprehensive registry for all clinical trials, according to American Medical News. One company, Merck, is already behind the movement. More than 300 clinical trial registries exist; the largest is www.clinicaltrials.gov. However, the AMA wants one comprehensive registry of published and unpublished data from clinical trials. According to American Medical News, an estimated 50% of results from clinical trials are never brought to light. A Willy-Nilly System According to a July 6 Washington Post article, the system of registering clinical trials is anything but consistent. Within the last few weeks, noted the Post, the database ClinicalTrials.gov had a list of more than 5,700 studies that were underway. Of these, only 13% were sponsored by industry, and 55% were sponsored by the federal government (most often by the National Institutes of Health). The article also highlighted the following: • In 2002, only 48% of trials of cancer drugs were registered. • Listing rates for some drugs that treat serious diseases are in the single digits. • Some companies haven’t listed any studies. • In some cases, trials are listed but they don’t include the sponsor or mention the drug that’s being tested. Enforcing a Little-Known Law There’s already a law that requires companies to register trials, however, it’s not enforced — probably because the statute doesn’t give the FDA any authority to levy penalties or come down on violators. Of course, there’s another side to this issue. Researchers are concerned how lay people could interpret — or misinterpret — data, and members of industry are worried about uncovering trade secrets. What are your thoughts about a comprehensive registry? n Larisa Hubbs Executive Editor lhubbs@hmpcommunications.com
C an you imagine having access to all of the latest data discovered in any clinical trial performed with a dermatologic drug? If a recent movement that’s been building among American Medical Association members gains the momentum it needs, then all practitioners could have access to valuable data that may guide their clinical decisions differently — and possibly more effectively. The American Medical Association endorsed a policy in June that calls for the Department of Health and Human Services to establish a comprehensive registry for all clinical trials, according to American Medical News. One company, Merck, is already behind the movement. More than 300 clinical trial registries exist; the largest is www.clinicaltrials.gov. However, the AMA wants one comprehensive registry of published and unpublished data from clinical trials. According to American Medical News, an estimated 50% of results from clinical trials are never brought to light. A Willy-Nilly System According to a July 6 Washington Post article, the system of registering clinical trials is anything but consistent. Within the last few weeks, noted the Post, the database ClinicalTrials.gov had a list of more than 5,700 studies that were underway. Of these, only 13% were sponsored by industry, and 55% were sponsored by the federal government (most often by the National Institutes of Health). The article also highlighted the following: • In 2002, only 48% of trials of cancer drugs were registered. • Listing rates for some drugs that treat serious diseases are in the single digits. • Some companies haven’t listed any studies. • In some cases, trials are listed but they don’t include the sponsor or mention the drug that’s being tested. Enforcing a Little-Known Law There’s already a law that requires companies to register trials, however, it’s not enforced — probably because the statute doesn’t give the FDA any authority to levy penalties or come down on violators. Of course, there’s another side to this issue. Researchers are concerned how lay people could interpret — or misinterpret — data, and members of industry are worried about uncovering trade secrets. What are your thoughts about a comprehensive registry? n Larisa Hubbs Executive Editor lhubbs@hmpcommunications.com
