From the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Dr. Neumann describes the challenge to the pharmaceutical industry in complying with what is expected as results of comparative effectiveness research studies are published.
Should we fund studies with 3,500 patients in each arm—comparing Potion A with Potion B—with little emphasis on disease biology? The answer, as eloquently explained by experts in North America and Europe is no.
In three lead editorials, the NEJM summarized the status of the Physician Payments Sunshine Act that requires public reporting of payments to physicians and teaching hospitals from pharmaceutical and medical device companies, as well as reporting of certain ownership interests.
Kaiser Permanente Northwest is apologizing to nearly 6,500 members in Oregon and Washington whose blood was tested for HIV without their knowledge or consent. Having just reviewed this issue for Central Oregon via the IRB, this apology is acutely relevant.
120 influential cancer researchers from 15 countries on 5 continents, including OHSU's Brian Druker, contend in a published commentary that the prices of drugs used to treat that disease are astronomical, unsustainable and perhaps even immoral.
JettPak, a phase I/II trial of a bedside nembulizer that allows children to sleep while inhaling asthma therapy, is set to accrue children 5 to 12 years of age. Contact www.jettstreaminc.com for more information.
Mar 01, 2013 7:00 am Center for Health and Learning - St. Charles - Bend
At the March 1 SCHS Grand Rounds, a clinical trial being conducted by Kimberly Swanson, PhD, at SCHS pediatric program in Redmond, in conjunction with Seattle Children's, Mary Bridge Children's Hospital in Tacoma and the University of North Carolina will be presented and discussed by the University of Washington PI.
On January 25, 2013, final regulations modifying the HIPAA privacy and security regulations were issued by the Department of Health and Human Services (HHS). Known as the “omnibus” privacy and security rule, it updates earlier HIPAA rules with more stringent privacy and security measures passed under the American Recovery and Reinvestment Act of 2009. Among other things, these regulations render clinical research more restrictive, including Genetic Information (GINA).
Jeffrey Abrams, MD, =Associate Director, Cancer£1-herapy Evaluation Program and Acting Director for Clinical Research, Division of Cancer Treatment and Diagnosis announces that the pilot program of NCI's CIRB including local context matters was a success.
As a result of the Supreme Court's June 28 decision, health insurance companies will be prohibited by or after January 1, 2014, from:1. Denying individual participation in an approved clinical trial.2. Denying or limiting, or imposing additional conditions on, the coverage of routine patient costs furnished in connection with participation in the approved clinical trial.3. Discriminating against the individual on the basis of the individual’s participation in the approved clinical trial.
The sham effect is alive and well in surgery today. More surgical procedures should be compared to sham controls, or the closest thing we can devise, to help us identify procedures of little or no intrinsic merit.
The ANPRM re: The Common Rule that would affect use of Central IRBs would require local IRBs to use central lIRBs for multisite trials that have a central IRB in the U.S. The Rule would not apply to multisite HDEs, does not specifiy a minimum number of sites, and specifically excludes non-domestic CIRBs. The period of public comment closed on October 26, 2011 with only 46 comments posted.
A rare bipartisan urgency as congressional lawmakers look to boost innovation and shorten the time it takes to approve medical technology that often gets a tryout in Europe long before reaching patients in the U.S. The effort comes as Congress readies wide-ranging FDA legislation that has pitted a $350 billion global medical device industry against consumer advocates in an ongoing battle over the U.S. oversight system, which alternately is criticized for being too stringent and too lax.
It's time to look beyond translation. Reengineering the health care enterprise to assimilate these cultural shifts, economic incentives, and necessary infrastructure will require major disruptive transformation,5 not simple translation. Anything less will continue to undermine medical advancement and keep us from turning today's biomedical promise into tomorrow's clinical realities
Frankovich J, Longhurst CA, Sutherland SM / NEJM / 365:1758-9, November 10, 2011 In lieu of clinical trial data to guide urgent therapy in a 13 year-old girl with SLE and acute pancreatitis, these Stanford pediatricians used their EHR to study their prior patients with the same condition and conduct a research project within hours.
Disclosing all clinical research results -- from drug trials and device studies -- would benefit the public, leading to greater patient safety, improved treatment research strategies, and more efficient use of limited resources, say two neuroscientists in a commentary published today in Science Translational Medicine. The authors call on the U.S. DHHS to use its authority to require reporting of clinical study results, even if product development is abandoned.
Experts on bioethics and clinical trials at the Department of Bioethics, National Institutes of Health and the Office for Human Research Protections (OHRP), Department of Health and Human Services review proposed changes in The Common Rule affecting cliinical research after 20 years without changes in the orignial ruling. They recommend that investigators comment on the Advance Notice of Proposed Rulemaking (ANPRM).
The heads of the Bioethics Committee at the NIH and the Office of Human Research Protections describe the current Advanced Notice of Public Rulemaking that proposes to streamline the IRB and informed consent process, including more centralization of IRBs.
This editorial in the September 15, 2011 issue of the New England Journal of Medicine (NEJM) and the one cited below n the same issue strongly support the July 29, 2011 recommendaiton of the Insitute of Mediciine (IOM) to eliminate the 35-year-old FDA policy to allow new medical devices be used in humans without clinical trials.
Each year, several thousand devices — about one third of devices entering the market — are cleared through the 510(k) process. What patients want is reasonable assurance that a device is clinically effective and that its benefits outweigh its risks — not merely an indication that it is substantially equivalent to another device--which the 510(k) process cannot assure. This editorial and the one cited above, both in the September 15, 2011 issue of the NEJM strongly support the July 29, 2011 recommendaiton of the Insitute of Mediciine (IOM) to eliminate the 35-year-old FDA policy to allow new medical devices be used in humans without clinical trials.
The clinical trial of Infuse, which was to be studied in Central Oregon (an IRB application was submitted) and intended to include hundreds of people, was halted after only 34 patients received Infuse implants. Infuse sales amount to several hundred million dollars a year.
The term “clinical benefit” is widely employed in the oncology arena.1 The question is, from whose perspective should “clinical benefit” be defined and documented: the investigator’s, the health care economist’s or the patient’s?
An international clinical trialist expert group, the Multicenter Research Group, recommends a paradigm switch in collaborative clinical research that requires the pharmaceutical and device industry to collaborate with academia, government and each other
A report carried The Bulletin describes how clinical trials bring prestige and first-string specialists to hospitals, and more importantly, hope to patients, but at significant financial cost to participating medical centers
Adaptive clinical trial designs based on Bayesian probability theory reduce the number of patients required for most clinical trials, increase the likeihood of benefit while simultaneously sparing patients from unnecessary harm, and are especially applicable to smaller communities and research centers like Central Oregon.
The U.S. clinical trials system is becoming increasingly cumbersome and unsatisfactory. As stated by John Mendelsohn, MD, president of the University of Texas M.D. Anderson Cancer Center: “If you don’t get a trial started within two years—and many don’t—you’re much less likely to complete it. After all that hard work you’ve done to make it perfect, you don’t get it done? That wastes time, effort and money, and is unfair to patients. People are tired of that.”
The Medical Director of the Research Department at the Bend Memorial Clinic and the Chair of the St. Charles Health System Institutional Review Board (IRB) presented a review of clinical trials in Central Oregon at the SCHS Grand Rounds on January 21, 2010
The Floyd and Delores Jones Cancer Institute at Virginia Mason was one of only ten community oncology practices in the U.S. to receive an American Society of Clinical Oncology Award for clinical trials accrual and participation
By Betsy Q. Cliff / The Bulletin / August 26. 2010The system for running clinical trials in this country is in shambles, experts say, and yet they are so important in determining how cancer is treated that without reform progress in treating cancer could stall
By Markian Hawryluk / The Bulletin / August 05. 2010Dr. Archie Bleyer was preparing for his fourth hip surgery when his doctor asked if he'd like to join a medical research trial. Knowing how important such trials can be, Bleyer didn't hesitate. But experts are worried that too few patients.
The nation’s largest network of clinical trials is hamstrung by a tangled bureaucracy, inadequate financial support and insufficient innovation, according to the 295-page report, “A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program”
A mobile compression device was found to be safer and less espensive thatn conventional low molecular weight heparin to prevent thrombosis in post-operative patients. The SCHS IRB Chair was one of the patients randomized on this study, which The_Bulletin published.
This week's JNCI report the lack of any therapeutic benefit of the popular use of shark cartilage to treat cancer. Dr. Bleyer helped lead the research when he was Medical Director, Community Oncology at the MD Anderson Cancer Center.
Four factors were found to be statistically and clinically significant: 1) clinician expertise and qualifications; 2) personal desire to participate; 3) perceived value of the trial; and 4) level of trial inconvenience. Trial inconvenience was the most statistically significant
The nation’s most important system for judging the clinical effectiveness of cancer treatments is approaching “a state of crisis.” That is the disturbing verdict of experts assembled by the National Academy of Sciences to review the performance of clinical trials sponsored by the National Cancer Institute.
Edward Boyle, MD and Archie Bleyer, MD conducted at phase 2 trial of low-dose spiral CT scanning for detection or early lung cancer in persons of high risk of lung cancer. After 75 persons were accrued, the trial was abandoned due to futility of subject enrollment. For final report, click here