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:12/6/2016)... Greifensee, Switzerland (PRWEB) , ... December 06, 2016 ... ... Library, a one-stop portal for all the knowledge resources, including white papers, ... instructions, certificates, and more. , To access more than 9,000 documents, webinars ...
(Date:12/6/2016)... ... ... 'Tis the season for family, festivity, food and fun! Temptation abounds, and ... eating healthy, staying active, and taking medication and doing daily foot health checks (a ... "Shopping trips, parties and family gatherings can take their toll on our feet during ...
(Date:12/6/2016)... ... December 06, 2016 , ... Specialty ... newly updated International Audit Protocol Consortium (IAPC) EHS audit protocol for Great ... understand the scope of their EHS regulatory obligations and rapidly collect, share, archive, ...
(Date:12/6/2016)... Aliso Viejo, California (PRWEB) , ... December 06, 2016 , ... ... which allows users to flicker, flash, and flare from clip to clip with high ... , TransFlare 4K Jewel contains 44 lens flares filmed on the RED ...
(Date:12/5/2016)... ... December 05, 2016 , ... "FCPX Overlay Glare is a tool that ... without heavy rendering or complicated compositing," said Christina Austin - CEO of Pixel Film ... organic spectrum of lights that simulates the look of a glare. Just drag ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... -- Spain Glaucoma Surgery Devices Market Outlook to 2022 ... Devices Market Outlook to 2022", provides key market data ... provides value, in millions of US dollars, volume (in ... Canaloplasty Micro Catheters and Glaucoma Drainage Devices. The ... for each of these market segements, and global corporate-level ...
(Date:12/5/2016)... NEW YORK , Dec. 5, 2016 Special ... collection of samples such as fluid and cells from organs ... advanced features, shapes, and sizes. The global market for special ... increasing geriatric population. In terms of revenue, the global special ... of 7.4% during the forecast period (2016–2026) and is expected ...
(Date:12/5/2016)... RATON, Fla. , Dec. 5, 2016 /PRNewswire-USNewswire/ ... Public Research (the Florida Institute) announced today ... LLC, an Orlando -based company ... The Florida Institute supports new company creation based ... for companies spinning out of Florida-based universities and research ...
Breaking Medicine Technology: