Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Stopping Clinical Trials Early Often Exaggerates Treatment Effects

24.03.2010
An international study of nearly 100 clinical trials that were stopped early due to positive treatment effects has found that many of those effects were exaggerated.

The authors of the study -- published in the current issue of the Journal of the American Medical Association -- recommend that researchers resist pressures to end clinical trials early and continue trials for longer periods before even considering premature termination.

“Our research shows that in most cases early stopping of clinical trials resulted in misleading estimates of treatment effects. These misleading estimates are likely to result in misguided decisions about the trade-off between risks and benefits of a therapy,” says Victor Montori, M.D., Mayo Clinic endocrinologist and corresponding author of the study. “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials. Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent.”

The clinical trials that Dr. Montori and colleagues studied were ended early because of a convincing -- and usually large -- apparent difference between an experimental treatment and an existing standard therapy. The studies were ended so participants taking a placebo or less effective medications could also take the studied drug. It usually also allows physicians to prescribe the therapy sooner because it will reach the market earlier.

Dr. Montori says almost everyone involved benefits from a trial ending early -- doctors, researchers, funding sources, pharmaceutical firms, scientific journals, even reporters -- everyone except the patient, who may end up receiving a therapy on the basis of misleading information about its benefits.

The researchers examined 63 medical questions regarding 91 truncated trials and compared them to 424 comparable trials that were not stopped early. Results showed that the studies that were stopped -- especially smaller trials of a few hundred participants -- had exaggerated or misleading treatment effects. Those misleading findings are often compounded downstream because researchers are less likely to return to the topic after what is perceived as a significant successful finding.

The authors recommend that researchers use restraint and truncate clinical trials only near the end of a study and then only with “a very good reason.” Otherwise, says Dr. Montori, patients and physicians will be making treatment choices based on inaccurate information, or worse, opting for one treatment when another may be more appropriate.

The study was supported by the Medical Research Council of the U.K. Other authors include Dirk Bassler, M.D.; Matthias Briel, M.D.; Qi Zhou, Ph.D.; Stephen Walter, Ph.D.; Gordon Guyatt, M.D.; and Diane Heels-Ansdell, all of McMaster University, Ontario; Melanie Lane, Mayo Clinic; and Paul Glasziou, M.B.B.S., Ph.D., University of Oxford, England.

About Mayo Clinic
For more than 100 years, millions of people from all walks of life have found answers at Mayo Clinic. These patients tell us they leave Mayo Clinic with peace of mind knowing they received care from the world's leading experts. Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. At Mayo Clinic, a team of specialists is assembled to take the time to listen, understand and care for patients' health issues and concerns. These teams draw from more than 3,700 physicians and scientists and 50,100 allied staff that work at Mayo Clinic’s campuses in Minnesota, Florida, and Arizona; and community-based providers in more than 70 locations in southern Minnesota, western Wisconsin and northeast Iowa. These locations treat more than half a million people each year. To best serve patients, Mayo Clinic works with many insurance companies, does not require a physician referral in most cases and is an in-network provider for millions of people. To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. For information about research and education, visit www.mayo.edu. MayoClinic.com (www.mayoclinic.com) is available as a resource for your general health information.

Robert Nellis | Newswise Science News
Further information:
http://www.mayo.edu

Further reports about: Cancer treatment Mayo Medical Wellness premature termination

More articles from Studies and Analyses:

nachricht A sudden drop in outdoor temperature increases the risk of respiratory infections
11.01.2017 | University of Gothenburg

nachricht Urbanization to convert 300,000 km2 of prime croplands
27.12.2016 | Mercator Research Institute on Global Commons and Climate Change (MCC) gGmbH

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

Im Focus: Studying fundamental particles in materials

Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales

Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...

Im Focus: Designing Architecture with Solar Building Envelopes

Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.

As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...

Im Focus: How to inflate a hardened concrete shell with a weight of 80 t

At TU Wien, an alternative for resource intensive formwork for the construction of concrete domes was developed. It is now used in a test dome for the Austrian Federal Railways Infrastructure (ÖBB Infrastruktur).

Concrete shells are efficient structures, but not very resource efficient. The formwork for the construction of concrete domes alone requires a high amount of...

Im Focus: Bacterial Pac Man molecule snaps at sugar

Many pathogens use certain sugar compounds from their host to help conceal themselves against the immune system. Scientists at the University of Bonn have now, in cooperation with researchers at the University of York in the United Kingdom, analyzed the dynamics of a bacterial molecule that is involved in this process. They demonstrate that the protein grabs onto the sugar molecule with a Pac Man-like chewing motion and holds it until it can be used. Their results could help design therapeutics that could make the protein poorer at grabbing and holding and hence compromise the pathogen in the host. The study has now been published in “Biophysical Journal”.

The cells of the mouth, nose and intestinal mucosa produce large quantities of a chemical called sialic acid. Many bacteria possess a special transport system...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

Nothing will happen without batteries making it happen!

05.01.2017 | Event News

 
Latest News

Water - as the underlying driver of the Earth’s carbon cycle

17.01.2017 | Earth Sciences

Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

17.01.2017 | Materials Sciences

Smart homes will “LISTEN” to your voice

17.01.2017 | Architecture and Construction

VideoLinks
B2B-VideoLinks
More VideoLinks >>>