Navigation Links
Cancer Drug Trials Often Halted Early
Date:4/11/2008

Without thorough review, Italian study says the trend poses risks to patients

FRIDAY, April 11 (HealthDay News) -- An increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated, say Italian researchers, who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.

The researchers looked at 25 randomized, controlled clinical trials that were stopped early because the treatments had started to show benefit to patients.

"When we analyzed 25 trials over a 10-year period between 1997 and 2007, we found a consistent increase in prematurely stopped trials -- more than 50 percent were stopped within the last three years," study co-author Giovanni Apolone, said at a news conference Tuesday.

Of 14 trials halted early and published between 2005 and 2007, the researchers found that 11 (79 percent) of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S. Food and Drug Administration.

"This suggests a strong commercial component in stopping trials prematurely. In fact, this strategy could guarantee quicker access to the market for companies. On the other hand, a quicker clinical drug development may lead to an 'immature' benefit/risk balance of new drugs," Apolone said.

He and his colleagues "are aware that trials stopped early because they are showing benefit may result in identification of promising new treatments for patients. However, findings obtained following this strategy should be considered to be preliminary results that require subsequent confirmation. We believe that only untruncated trials can provide the full level of evidence required to safely translate treatments into clinical practice. Without such evidence, unsafe and ineffective drugs could be marketed and prescribed, and patients' health could be jeopardized."

It can take several years for the long-term benefits or harmful side effects of a new treatment to become apparent, Apolone noted, but the average duration of the 25 studies he and his colleagues analyzed was 30 months, with a range from 12 to 64 months.

They also found that at the time five of the studies were stopped, they'd enrolled less than 40 percent of the total number of patients planned for final analysis.

The findings were published online April 9 in the Annals of Oncology.

"Clinical trails need to stop early for superior benefit whenever there's proof beyond reasonable doubt that the new treatment really is superior. That would be an ethical obligation," Stuart Pocock, a professor of medical statistics at the London School of Hygiene and Tropical Medicine in the United Kingdom, said at the news conference. "However, too many trials are stopped early claiming efficacy without strong evidence being available."

Pocock wasn't involved in the study.

More information

The U.S. National Cancer Institute has more about clinical trials.



-- Robert Preidt



SOURCE: European Society for Medical Oncology, news release, April 8, 2008


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Mammography plus sonography can help rule out breast cancer in patients with palpable lesions
2. Newly diagnosed breast cancer patients benefit from use of USFNA of lymph nodes
3. New technique in treating patients with liver cancer proves effective
4. McCarty Cancer Foundation Awards $50,000 Grant for Myeloma Research Program at Karmanos Cancer Institute
5. MRI changes breast cancer treatment choice; increases time to treatment
6. A diagnosis of triple-negative breast cancer doesnt always mean cancer spread
7. MRI best for looking at breast cancer and more
8. 3T MRI plays significant role in detecting prostate cancer, study says
9. MRI and PET/CT can prevent unnecessary treatment of some cervical cancer patients
10. Stem cells and cancer: Scientists investigate a fine balancing act
11. Mayo Clinic identifies treatment target for liver cancer recurrence and survival
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... FLA (PRWEB) , ... February 12, 2016 , ... Miami ... dental implants to their Miami dental office. Beginning in January, Miami Dental Specialists ... titanium. Miami Dental Specialists are the first office to be chosen by the dental ...
(Date:2/12/2016)... ... February 12, 2016 , ... Atlantic ... for Health Plans and PBMs,” an upcoming Feb. 24 webinar that will discuss ... in big-dollar therapeutic categories, such as the $1,000-per-pill hepatitis C treatment Sovaldi and ...
(Date:2/12/2016)... ... ... Coast Autism Spectrum Center (CCASC) invites teens ages 11-18 to its annual Winter Teen Dance. ... and without special needs to gather in a safe and supportive environment. Volunteers will be ... place on Saturday, Feb. 13 from 7 to 9:30 p.m. at Elks Lodge, 322 Elks ...
(Date:2/12/2016)... ... February 12, 2016 , ... With the exception of restorative dentistry, to date there has ... With the recent approval by the FDA, there is a now a new protocol in ... SDF is very simple and quick to apply. The application is as simple as ...
(Date:2/11/2016)... ... February 11, 2016 , ... SPH Analytics announced ... analytics leader’s population health solutions, MDinsight® and IndiGO®, for its primary care clinicians. ... system. Details of the contract were not disclosed. , As the healthcare market ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... FRANCISCO , Feb. 11, 2016  Kindred Biosciences, ... on saving and improving the lives of pets, today ... Section of the New Animal Drug Application (NADA) for ... pivotal field study (KB0120) of Zimeta for the control ... the Company. --> --> ...
(Date:2/11/2016)... Feb. 11, 2016  Governor Andrew M. Cuomo today ... 1,400 jobs throughout Western New York ... the SUNY Polytechnic Institute, includes a major expansion of ... Buffalo , as well as the ... in Dunkirk . The combined projects ...
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016 Potrero ... system, is pleased to announce the appointment of George ... San Antonio, TX , WellMed is ... servicing over 200,000 patients and HMO members in ... founding WellMed in 1990 out of his own internal medicine ...
Breaking Medicine Technology: