Seeking the latest results from clinical trials?
By Herb Drill
If you or someone you hold dear is seriously ill, you want to do everything you can to help, including offering pertinent data from clinical trials.
Lending a hand in this regard, was an article in The Wall Street Journal concerning the current push to require drug companies to disclose results from unpublished clinical trials. That data “could unleash a flood of new information for doctors and patients,” The Journal stated; meanwhile, there is a growing effort by medical publishers, scientific groups, and government agencies aimed at helping people find and interpret clinical trials results online.
Existing registries are run by the National Institutes of Health and many private organizations. Web sites like MedlinePlus.gov offer direct links to most published medical studies. Some are free or can be purchased directly from the mentioned medical journal. More help is being developed; i.e., a guide from the National Library of Medicine on understanding such reports.
Most efforts highlight published studies; unpublished research is sometimes available on the Web sites of medical specialty conferences, where researchers may present work which isn't published later. A study in the 1990s of research submitted to a meeting of the Society for Academic Emergency Medicine noted that of 223 unpublished investigators studied, only 20% had submitted manuscripts to a journal.
At present in the U.S. alone, there are close to 50,000 clinical trials ongoing. Much of the research is in dense medical language, but there are resources which can help consumers find information on trial results in plain language, plus tips on how to weigh their legitimacy by assessing factors such as how many patients were involved and who paid for the research.
The American Medical Association has recommend the U.S. Dept. of Health and Human Services develop a registry of all clinical trials and their outcomes.
Editors of some medical journals say they have discussed requiring companies to register in a trial database as a condition of publication in the journals, The Journal reported.
Among the most comprehensive sources for clinical trial data is the Cochrane Collaboration, a U.K.-based nonprofit group which advocates broad disclosure of evidence from clinical trials. It has volunteers who search the world's medical literature to find randomized clinical trials. Consumers can sift through free reports at www.trialscentral.org. The National Cancer Institute's cancer.gov site reports regularly on findings from published cancer clinical trials.
At the National Library of Medicine's ClinicalTrials.gov site, users can click on the "What's New" icon, then have the search include all completed trials submitted in the past seven or 30 days. By law, all trials of drugs for life-threatening conditions must be entered in this government registry. The library is developing an online guide to help consumers understand reports from clinical trial research.
MedlinePlus.gov, the consumer-oriented version of the National Library of Medicine's site, helps distill much of the data from drug tests in drug dictionaries, encyclopedia and glossary which makes it easier to understand risks and benefits.
For more information, these sites are helpful:
· Clinicaltrials.gov - A service of the National Institutes of
Health; largest register of federally- and privately-supported clinical research in human volunteers.
· Cancer.gov - National Cancer Institute's registry of cancer
clinical trials, with 1,900 open trials listed and links to latest clinical trial results for breast cancer, colon cancer, lung cancer, and others, with easy-to-understand summaries.
· Centerwatch.com - Free listings of more than 41,000 active
industry and government-sponsored clinical trials; sponsored by company which recruits participants/
· Trialscentral.org – Trial listings Web site of the Center for
Clinical Trials and Evidence-Based Healthcare at Brown University Medical Center. It’s affiliated with the U.K.-based Cochrane Collaboration, pioneer in development of "evidence-based" medical guidelines; links to summaries of reviews of evidence from trials.
· Medlineplus.gov - National Library of Medicine consumer site with
link to PubMed, its bibliographic database site with citations and abstracts from nearly 4,500 journals worldwide.
· FDA.gov/medwatch - Offers safety information on drugs and other
medical products regulated by the U.S. Food and Drug Administration.
· Drugs.com - Free advertiser-supported drug information. Free
access to medical studies from hundreds of journals. Supported by unrestricted grants from several drug companies.
Here are some guidelines to evaluate such studies:
What's the source? Studies in peer-reviewed journals such as the American Medical Association or Lancet have editorial boards who review studies for publication. Specialty journals often contain the best studies on specific diseases and conditions, such as circulation for heart conditions.
Studies conducted by university teaching hospitals or funded by the National Institutes of Health are often the most reliable.
Who was studied? "If the study says it looked at white males 34-50, it isn't going to have a lot of relevance for a 64-year-old white woman," says John Schneider, an internist who is chairman of the AMA's council of scientific affairs.
How was the study conducted? Double-blinded randomized controlled trial studies are usually considered the most valid. That means neither the
investigator nor the trial participant know who is receiving a drug and who is receiving a placebo.
What do the statistics mean? In general, trial results are considered statistically significant if there is a less than 5% probability the difference observed would occur by chance alone. A primer from Englewood, CO-based Craig Hospital for Spinal Cord Injuries (www.craighospital.org), titled Those Scary Statistics, helps explain statistics used in research.