|
AHC Media, publisher of
Clinical Trials Administrator, IRB Advisor, Medical Ethics Advisor and
Drug Formulary Review, welcomes you to the first
Clinical Trials Weekly Alert, which is sent to update you on clinical trial regulatory
and management issues. We hope you will find this alert informative and useful.
If you wish to continue receiving this free weekly e-mail, subscribe by
clicking here. If you prefer not to receive this weekly Alert you do not need to do anything. Your name will automatically be removed from the subscription list if you do not subscribe.
This Week's Headlines:
Component Analysis is Latest Model for IRB Review Process, Particularly with Kids
Model places greater demand on balancing risks and benefits
A movement slowly gaining ground in North America suggests an alternative way to assess the risks and benefits of human subjects research, particularly when studies involve children.
Called component analysis, the method is different from the more commonly used collective analysis. It sets the IRB review bar a little higher by requiring a more stringent look at various pieces of a proposed study's protocol.
Investigators and clinical trial sites could find the IRB review process more rigorous than it is currently if greater numbers of IRBs begin to use component analysis.
The idea of component analysis was formed in the early 1990's in the Clinical Trials Research Group (CTRG) of McGill University's Biomedical Ethics Unit of Montreal, Quebec, Canada, says Charles Weijer, MD, PhD, an associate professor of philosophy and medicine and the Canada research chair in bioethics at the University of Western Ontario in London, Ontario, Canada.
"Some of the earliest parts of component analysis were formed in that group led by Benjamin Freedman, a well-known philosopher and thinker on ethics," Weijer says.
Freedman was the co-founder and director of the CTRG. He died in 1997.
Other groups have struggled with finding a way to conceptualize research benefits and harms, Weijer notes.
"The National Commission, which wrote the Belmont Report, and their view in the end, and report on IRBs, is quite close to component analysis," Weijer says. "So it's an idea that has strong historical roots in the U.S."
The question germane to the whole issue of component analysis is this one: Can anticipated direct benefit that is associated with one intervention in a protocol be used to justify the risks of another intervention? says Ernest Prentice, PhD, an associate vice chancellor for academic affairs at the University of Nebraska Medical Center in Omaha, NE, and chair of the Secretary's Advisory Committee on Human Research Protection (SACHRP) for the U.S. Department of Health and Human Services.
Under collective analysis, an IRB will assess the composite of all of the interventions detailed in a study and assess whether the use of interventions that do not provide a prospect of direct benefit is justified by the sum of anticipated benefits associated with those interventions that do have the prospect of direct benefit, Prentice explains.
[For more information, see the February 2007 issue of Clinical Trials Administrator newsletter.]
— Leslie Hamlin, managing editor
Back to top
WHO's International Clinical Trials Registration Data Set
As of May 2006, The World Health Organization's International Clinical Trial Registry Platform has created a list of 20 items necessary for the registration of a clinical trial. For a clinical trial to be registered, "all items must be recorded as applicable in a Primary Registry." These items are as follows:
- Primary register and trial ID#;
- Date of registration in primary register;
- Secondary ID#s;
- Source(s) of monetary or material support;
- Primary sponsor;
- Secondary sponsor(s);
- Contact for public queries;
- Contact for scientific queries;
- Public title;
- Scientific title;
- Countries of recruitment;
- Health condition(s) or problem(s) studied;
- Intervention(s);
- Key inclusion and exclusion criteria;
- Study type;
- Date of first enrollment;
- Target sample size;
- Recruitment status;
- Primary outcome(s);
- Key secondary outcomes.
Back to top
On-line Journal Provides Industry with Open Access
Journal wants all results — positive and negative
A relative newcomer to the world of journal publishing is working on improving human subjects and other research through greater transparency and easier access to results — both the positive and the negative.
The Public Library of Science (PLoS) in Cambridge, United Kingdom, was established in 2000, primarily for the purpose of providing the public access to research papers.
The one-time fee is $1,250 to $2,500. For those who cannot find funds for the publication fee, they can specify this when they submit their study, and if the study is accepted for publication, the fee will be waived.
[For more information, access PLoS at
www.plosclinicaltrials.org.]
Reference
1. Wager E. Publishing clinical trial results: The future beacons.
PLoS Clinical Trials. October, 2006:e31:1-4. Web:
www.plosclinicaltrials.org.
Back to top
Avoid Common Mistakes when Dealing with the IRB
Volunteer for IRB service, if possible
"Many investigators are used to getting critiques and criticisms through peer review from federal grants, and if they could see the IRB review as a similar mechanism of improvement of the science and protections of human subjects, then they could come out with stronger protocols and change their attitude," says Brad Noren, MA, CIP, research and contracts administrator for the Oregon Health and Science University, department of ophthalmology in Portland, OR.
Noren offers these tips on how to improve investigator-IRB relations:
- join the local IRB;
- address all points IRB raises in response to review;
- provide literature citations when indicated;
- request previews judiciously;
- respect the IRB office's workflow issues.
Back to top
|
