Premature End to Drug Tests may Not Give Out Precise Results: Study

A study published in the Journal of the American Medical Association has revealed that the results of clinical trials that ended early may not be precise and could often be exaggerated.

The conclusion was based on an international study by a team lead by Victor Montori, an endocrinologist at the Mayo Clinic in Rochester, Minnesota.

Clinical Trials | Drug Trials - Types Protocol Development and Approval FAQs
Clinical trials are experiments that yield useful information to clinicians if a particular treatment is of any value to a patient.

The team studied 91 clinical trials that were ended early, and compared them to 424 trials that were completed.

The trials that were ended early were cut short because of what appeared to be convincing evidence that the experimental treatment was markedly better than the existing therapy.

Test subjects taking a placebo could then also take the drug that was being tested, and the item could be on the market sooner, the researchers said.

Clinical Trials and Its different Phases
Clinical trials serve as a vital component for improving the treatment of medical conditions as they lead to higher standards of patient care.

Almost everyone -- doctors, researchers, funding sources, pharmaceutical firms, scientific journals, even reporters -- benefits from a trial ending early, Montori said.

Patients, however, may end up with a treatment that may not be as beneficial as it appears.

Gays and Lesbians Excluded From Some Clinical Trials: Study
Some clinical trials financed by the US federal government and pharmaceutical labs exclude gay and lesbian participants, finds a study published Wednesday.

"Our research shows that in most cases early stopping of clinical trials resulted in misleading estimates of treatment effects," Montori said.

"These misleading estimates are likely to result in misguided decisions about the trade-off between risks and benefits of a therapy."

New Law on Clinical Trials on the Anvil
The Union Health Ministry of India has revealed that it will be reviewing the Bill for Research on Human Subjects

Montori and the authors urged researchers to resist pressure to end clinical trials early and continue the tests for longer periods before they consider early termination.

Source-AFP
SAV