Clinical Trials Are Not all Getting Published In the Government Data Base
Posted Sep 05 2009 10:21pm
This report might help explain why companies, such as Outcome are in existence today. You can read more at the link below and why the company has received stimulus funds to continue their work. Once the trial is done, Outcome creates patient registries to report back on medications in how they are working in the real world, so if investigators change the reporting on the outcome, we have this to fall back on, although it does take time to gather, it is a big step towards transparency and finding out what is really happening.
Goals are to have real time information to decision makers; the patients, physicians and insurers. The information is available and stored with “cloud technology”. BD
“This is a very informative article/interview to find out what Outcome Sciences does, clinical outcomes and using patient registries. It is a public company and received stimulus funds. Outcome was a spinout from Harvard a few years back. Part of the work studies real world results andcompares them to clinical trials/studies. As we all know clinical trials are a small limited group, so once the medication is out in the real world they collect even more data as everyone wants to know if it works, what are the real or other side effects that may not have shown in a trial.
Safety, effectiveness and and quality are the three focuses with their studies.”
Many researchers are ignoring a 2005 requirement that they register proposed clinical trials in a government database as a condition for publishing their results in medical journals. And the journals are publishing the papers anyway, a new study reveals.
The study, a review of 323 articles published last year in leading medical journals, found that only 147 of the clinical trials — 45.5 percent — were properly registered before the end of the trial in a way that clearly stated the main outcomes being assessed. Even among the articles that were registered, almost a third had discrepancies between the outcomes described in the registry and the ones ultimately reported.
Dr. Moher added that bias could easily be introduced when investigators changed the primary outcome they were measuring — moving the goalpost, so to speak. That might happen, for example, if a clinical trial is designed to determine whether a drug increases survival rates but investigators change the primary outcome to assessing if the drug improves quality of life.