News about Clinical Research and Clinical Trials in Central Oregon


    Sham Surgery for Controlled Clinical Trials
Dec 31, 2013
In another demonstration of the importance of sham surgery controls, this time from Finland, a trial of patients with symptoms of a degenerative medial meniscus tear finds that the outcomes after arthroscopic partial meniscectomy were no better than those who had a sham surgical procedure. (ClinicalTrials.gov number, NCT00549172.)



    Spotting Spin and Bias: Reading Clinical Trial Results Critically
Dec 31, 2013
In recent years, physicians have adopted standards of care based on clinical trial data that are not always scientifically solid. In some cases, new practice patterns may have caused more harm than good. At the world's largest meeting of oncologists in 2013, three clinicians discussed how doctors can approach reports of clinical trial data more critically and spot spin and bias.



    Communicating and Promoting Comparative-Effectiveness Research Findings
Aug 05, 2013
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.



    Cancer Clinical Trials—Do We Need a New Algorithm in the Age of Stratified Medicine?
Aug 04, 2013
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.



    Do Clinical Trials Work?
Jul 21, 2013
Companies spend billions of dollars on drug testing each year. And yet for a surprising number of medicines, we still don't know if they're safe.



    New England Journal of Medicine Publishes Sunshine Data and Law Status
May 30, 2013
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.



    Health Group Apologizes for Not Disclosing HIV Testing
May 17, 2013
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.



    Principal Investigators Denounce Cancer Drug Prices of $100,000 a Year
Apr 25, 2013
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.



    Medical Device [JettPak] Originated Locally Set for Trials
Mar 12, 2013
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.



    Publicly Funded Clinical Trials and the Future of Cancer Care
Mar 09, 2013
Richard Shilsky, MD, prior Chair of the Cancer and Leukmia Group B, reviews the importance of govenment sponsored cooperative group trials compared to industry-sponsored trials. 



    Managing Childhood Functional Abdominal Pain
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.



    Dr. Verheyden to Report his Investigator-Initiated Treatment of Dupuytren's Contracture
Feb 16, 2013
Manuscript submitted to Journal of Hand Surgery
Central Oregons's James A. Verheyden, MD, Medical Director of the Cascade SurgiCenter, has submitted a report on his Xiaflex trial to the Journal of Hand Surgery. 



    Spin and Bias Common in Reports of Breast Cancer Clinical Trials
Feb 11, 2013
Spin and bias are prevalent in a high percentage of published studies about randomized, clinical trials of breast cancer treatments.



    DHHS Implements the Omnibus HIPAA Privacy & Security Rules
Jan 25, 2013
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).



    Springfield Woman Tests ‘Smart Bomb’ Cancer Drug, Saving Herself and Others
Jan 24, 2013
A Springfield, Oregon woman volunteers for a clinical trial and becomes one of the first patients in the world to receive it for her type of lymphoma.



    Research Misconduct on the Rise
Dec 15, 2012
Outright fraud rare, but selective analyses and reporting "highly prevalent"



    Delivering Asthma Treatments
Nov 15, 2012
Bend company's device cuts out the struggle when treating children



    Drug Trials: Often Long On Hype, Short on Gains
Oct 31, 2012
The delusion of ‘significance’ in drug trials, as exemplied by three major phase III cancer trials reported this year that had statistical- but hardly clinical- or substantial- significance.



    NCI Announces Success of Independent Model of CIRB Pilot
Oct 22, 2012
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.



    Clinical Trial Monitoring and Costs Through Remote Access to Electronic Records
Oct 09, 2012
Remote access to patient eMRs for source data verification is feasible and efficient.



    Transparency for Clinical Trials — The TEST Act
Aug 08, 2012
The Editor-in-Chief of the New England Journal of Medicine describes how the TEST legislation can improve clinical reserach throughout the world. 



    Brief Multimedia Psychoeducational Intervention on the Attitudes and Interest of Patients
Jul 11, 2012
A brief psychoeducational intervention improved the attitudes of patients with cancer toward clinical trials and thereby increased their willingness to participate in clinical trials.



    Justice for Injured Research Subjects
Jul 05, 2012
A prominent bioethicist argues for laws that protect research subject to balance the many laws that protect researchers.



    Supreme Court Decision Requires Insurers to Cover Approved Clinical Trials
Jun 28, 2012
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.



    Sham Surgery for Controlled Clinical Trials
May 20, 2012
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.  



    Advanced Notice of Rule Making re: Central IRBs
May 18, 2012
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 Push to Streamline New-Device Approval
May 10, 2012
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.



    Looking beyond Translation — Integrating Clinical Research with Medical Practice
May 03, 2012
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



    Evidence-Based Medicine in the EMR Era
Nov 10, 2011
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.



    Researchers Call For Release of All Clinical Research Results, Positive or Negative
Sep 29, 2011
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.



    Reforming the Regulations Governing Research
Sep 22, 2011
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).



    Reforming the Regulations Governing Research
Sep 22, 2011
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.



    Second Lawsuit Filed in Falsified Cancer Research
Sep 19, 2011
A second patient whose cancer treated was predicated on falsified clinical reserach has sued the university healthcare system, researchers, and research company



    Medical Devices - Balancing Regulation and Innovation
Sep 15, 2011
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.



    Medical Devices and Health - Creating a New Regulatory Framework
Sep 15, 2011
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.



    Central Oregon Clinical Research Associates Polled for ICF Procedure Opinions
Aug 30, 2011
Twelve CRAs comleted a survey of their attitudes, experiences and challenges with ICF and the SHCS IRB management of ICF submissions, reviews and approvals.



    Docs Suspected of Fudging Data on Spinal Product for Financial Gain
Jun 29, 2011
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.



    Clinical Benefit in Clinical Trials: From Whose Perspective?
Apr 18, 2011
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?



    Collaborative Clinical Trials
Mar 03, 2011
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



    For Patients, Clinical Trials Offer Hope
Mar 03, 2011
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 Trials: The Promise and the Caution
Feb 20, 2011
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 It Losing Ground?
Jan 22, 2011
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.”



    Central Oregon Clinical Research Summarized at St. Charles Grand Rounds
Jan 21, 2011
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



    National Cancer Institute Announces Plans to Reinvigorate Clinical Trials
Dec 23, 2010
After 55 years of sponsoring cancer trials cooperative groups, the NCI has taken the bull by the horns and announced the current 10 cooperative groups would be consolidated into five organizations.



    Patients who Participate in Clinical Trials Benefit from Better Healthcare Afterwards
Dec 19, 2010
Long-term CRC survivors who participated in clinical trials achieved better routine preventive care and cancer screening than the general population and high rates of cancer surveillance



    Clinical Trials Data Collection: When Less Is More
Dec 01, 2010
This editiorial should be requried reading for sponsors and contract research organizations for pharma trials and their study monitors.



    Impact of 2010 Affordable Care Act Published by IRB Chair
Nov 01, 2010
Dr. Bleyer's article entitled "Potential Favorable Impact of the Affordable Care Act on Cancer in Young Adults in the United States" was published.



    Cancer Trials Suspended for New Patients
Oct 21, 2010
FDA audit leads Beth Israel Deaconess in Boston, associated with the Dana Farber Cancer Institute, to shut down new cancer trials,  citing research data lapse



    Major Payments Often Undisclosed in Journals
Sep 14, 2010
Study finds ‘massive, dramatic system failure’



    Seattle-Based Community Oncology Practice Honored for Clinical Trials Accrual
Sep 12, 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



    Acupuncture Trial To Open
Sep 10, 2010
A clinical trial for head and neck cancer patient undergoing radiotherapy using acupuncture to help prevent, or reduce the severity of, mucositis and dry mouth (xerostomia) opened on October 21, 2010



    Hurdles on the Road to a Clinical Trial
Aug 26, 2010
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



    Early Warning: An Ailing Canary in the Mine
Aug 23, 2010
David Dilts, PhD, of Oregon Health and Science Univiersity, warns us how the U.S. clinical trial enterprise is falling further and futher behind Europe's progress.



    Are Clinical Trials Worth the Risk?
Aug 06, 2010
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 Center Participates in Landmark Study
Aug 03, 2010
New method to preventing deep venous thrombosis and pulmonary embolism After hip replacement surgery is applicable to all types of surgeries requiring post-op anticoagulation



    Don't Mess with the DSMB
Jul 07, 2010
The New England Journal of Medicine Editorial Staff reviews two examples of why Data Safety Monitoring Boards should not be circumvented.  Period.



    St. Charles CFO Approves New Pre-IRB Resource Utilization Form
Jun 21, 2010
The opportunity to revise the pre-IRB approval process enables the combination of three existing forms into one



    St. Charles Health System Purchases IRBManager
Jun 07, 2010
The FDA Audit in March identified a need for the SCHS IRB to use a CFR Part 11 compliant software system.



    OHRP Reverses Opposition to Central IRBs
Jun 04, 2010
The Office of Human Research Protections joins the FDA in supporting central IRBs (CIRB) after reversing it's stand against local IRBs using CIRBs; Proposed ruling open for comment



    IOM Report Predicts Troubled Future for Cancer Research
Jun 01, 2010
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”



    Clinical Trial Including 30 Central Oregon Patients Published
May 30, 2010
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.



    Negative CAM Trial Finally Published
May 26, 2010
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.



    ASCO-NCI State-of-Science Conference on Clinical Trials Presentations
May 21, 2010
NCI-ASCO Clinical Trial Symposium presentations are now available online



    Accrual Barriers onto Breast Cancer Prevention Clinical Trials
May 05, 2010
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



    Faltering Cancer Trials
Apr 24, 2010
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.



    Overhaul of NCI Clinical Trial Enterprise Declared Essential
Apr 15, 2010
Overhaul of NCI Cooperative Group Program Needed to Ensure It Can Continue to Conduct Important Cancer Clinical Research



    2010 Patient Protection and Affordable Care Act & Clinical Research
Mar 23, 2010
2010 Health Care Act will ensure Coverage for Individuals Participating in Clinical Trials.



    Central Oregon Early Lung Cancer Screening (CO-ELCS) Phase 2 Trial
Oct 23, 2006
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



    Readability Standards for Informed-Consent Forms as Compared with Actual Readability
Feb 20, 2003
Reported in 2003, this New England Journal of Medicine artilcle confirms how unreadable ICFs were (and continue to be).



    Restless Legs Syndrome Study Closed
Apr 19, 2010
The Central Oregon investigator-initiated Restless Legs Syndrome drug trial closed prematurely due to slow patient accrual



    Brain Tumor Trial to Open
May 19, 2010
A new trial for patients diagnosed to have one of the most malignant of all brain tumors, glioblastoma multiforme, was approved for enrollment by the St. Charles Health System IRB.




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