Navigation Links
Cancer studies often lack necessary rigor to answer key questions
Date:4/29/2013

DURHAM, N.C. Fueled in part by an inclination to speed new treatments to patients, research studies for cancer therapies tend to be smaller and less robust than for other diseases.

This raises some questions about how cancer therapies will work in practice, according to researchers at Duke Medicine, who published an analysis of nearly 9,000 oncology clinical research studies online April 29, 2013, in the journal JAMA Internal Medicine. The studies they looked at were registered on the ClinicalTrials.gov website from 2007-10.

The analysis is part of the Clinical Trials Transformation Initiative, a public-private partnership founded by the U.S. Food and Drug Administration and Duke University to identify and promote practices to improve clinical research.

"We need to understand the strengths and weaknesses of the clinical studies in oncology," said Bradford Hirsch, M.D., assistant professor of medicine and lead author of the study. "There are a lot of reasons for why cancer studies are different than those for other illnesses cancer is a very grave disease and for a long time there weren't a lot of treatment options. But what we're trying to understand is if those differences justify differences in the clinical research being conducted."

Hirsch and colleagues found that oncology clinical research studies were predominantly small, early phase trials that evaluate a single treatment without comparing it to other therapies. Larger, more rigorous trials randomly assign patients to different treatments, "blinding" both doctors and patients from knowing who received the investigational therapy in an effort to eliminate bias.

This orientation toward less robust design differs significantly from other areas of medicine. The trend is partially explained by the accelerated approval process embraced by the FDA since 1992 to improve access to treatments for life-threatening diseases such as cancer. As part of that process, early-phase clinical research studies often measure goals other than extending survival.

In addition, drugs marketed for one use and used "off label" for others have less stringent requirements for winning additional regulatory approvals.

"An inherent tension arises between the desire to use new, life-saving treatments and the imperative to develop the evidence that patients, clinicians, regulatory agencies, and advocacy groups need to make sound decisions." Hirsch said. "Unfortunately, the high prevalence of small studies that lack rigor limits the ability to assess the evidence supporting specific treatments."

Hirsch said the analysis also brought to light some disparities between the incidence and mortality of some cancer types, and the volume of clinical research being conducted. For example, lung cancer has the highest incidence, with 14.5 percent of all new diagnoses and 27.6 percent of all cancer deaths in 2010, but was the focus of only 9.2 percent of studies on the register. Meanwhile, lymphoma was the focus of 6.6 percent of studies, while it represents 4.8 percent of cancer cases and 3.8 percent of deaths.

"People who enroll in clinical trials expect their participation to lead to future benefits for patients," said Nancy Roach, chair of the board of directors for Fight Colorectal Cancer. "Small, single-institution trials are not likely to change the standard of care. I see this paper as a call to action to encourage academic institutions to collaborate with each other on more robust trials that may ultimately lead to clinical benefit."


'/>"/>

Contact: Sarah Avery
sarah.avery@duke.edu
919-660-1306
Duke University Medical Center
Source:Eurekalert

Related medicine news :

1. VEGF may not be relevant biomarker for advanced prostate cancer
2. Postcode inequality for cancer diagnosis costs lives
3. Clarifying the effect of stem cell therapy on cancer
4. How does pregnancy reduce breast cancer risk?
5. GW Cancer Institute publishes research on challenges faced by adolescent cancer survivors
6. Battery of tests on cancer cells shows them as squishy, yet tactically strong
7. Voices Against Brain Cancer Responds to Research Identifying New Way Doctors Can Detect Whether Breast Cancer Will Spread to Brain
8. Lung Cancer Asbestos Victims Center Now Urges US Navy Veterans Diagnosed With Lung Cancer To Call Them About Compensation If They Were Exposed To Asbestos In The Service
9. Cardio could hold key to cancer cure
10. UK study shows potential new way to detect colorectal and other cancers
11. Research: Chemoresponse assay helps boost ovarian cancer survival
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... ... closing of Bruton Memorial Library on June 21 due to a possible lice infestation, as ... of head lice: the parasite’s ability to live away from a human host, and to ... one in the event that lice have simply gotten out of control. , As lice ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 2016 One of Australia,s successful ... of a new biotechnology company, Noxopharm Limited [ABN 50 608 966 ... and to list on the ASX. Noxopharm is a ... enter a Phase 1 clinical study later this year. ... of the biggest problems facing cancer patients - the ability of ...
(Date:6/26/2016)... 2016 Jazz Pharmaceuticals plc (Nasdaq: ... Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), ... Inc. ("Celator"; Nasdaq: CPXX ) expired effective ... As previously announced on May 31, 2016, ... agreement under which Jazz Pharmaceuticals has commenced a tender ...
(Date:6/26/2016)... -- VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) reported today ... to build a strong and stable market for trading ... the OTC Markets-pink current trading platform. Explains ... seeing an anomaly in market trading activities that may ... Company, but shareholders and market players as well. I ...
Breaking Medicine Technology: