Literature, Publications, Reports, Other References on Clinical Trials

Sentinal publications on clinical research of importance to Central Oregon

Increasing Clinical Trial Accruals in the Community Setting  
The NCI Community Clinical Oncology Program (CCOP) and the University of North Carolina CCOP determined that the most important factors for high treatment trial accrual was 1) trial availibiility and 2) patient volume.

Impact of the 2010 Affordable Care Act on Clinical Research  
In the Nov/Dec 2010 issue of The Cancer Journal, Dr. Bleyer summarizes the potential impact of the 2010 Affordable Care Act on young adults with respect to cancer.  The section on clinical trials has direct relevance to all patients, regardless of disease or age.

The Paradoxial Problem with Multiple-IRB Review  
Jerry Menikoff, MD, JD  /  N Engl J Med  /  363(17):1591-3;2010
Dr. Menikoff describes how central IRBs not only reduce the workload of local IRBs but may also improve the protection of people who volunteer to participate in research

Duke Scandal Leads to Data Access Reform  
The discovery that the credentials and data of a well-published Duke researcher is leading to data access reform

? Medical Therapy Benefit in Phase III Clinical Trials for Breast and Colorectal Cancer  
Seruga B, Hertz C, Wang L, Booth W,  Cescon W, Kryzanowska M, Tannock IF.  Annal Oncol 2010;21(7):1411-8
1.  From 1975 to 2007, randomized clinical trials have shown no statistical improvement in the outcome of patients with metatstatic breast or colorectal cancer, yet the cost per month of treatment has inceased from <$100 to >$5000/month. 
2.  The improvement during the past quarter century in the outcome of patients treated with adjuvant therapy did improve but at an incrementally slower pace. 
3.  The area under the curve (AUC) method for outcome analysis is preferred to single-time point evaluations.

Collecting Biospecimens from Patients on Clinical Trials  
Allison R. Baer, RN, BSN, Mary Lou Smith, JD, MBA, Deborah Collyar, BS, Jeffrey Peppercorn, MD, MPH
J Oncology Practice 6(4):206-9, 2010
This ASCO Exemplary Research report covers the issues, including ethics,* or collecting and requiring tissue specimens from patients who participate in cancer clinical trials.
*Peppercorn J, Shapira I, Collyar D, et al: Ethics of mandatory research biopsy for correlative endpoints within clinical trials in oncology. J Clin Oncol 28:2635-2640, 2010

Physician-Industry Potential Conflict Disclosures   
Steinbrook R.  Online Disclosure of Physician–Industry Relationships  /  N Engl J Med 360:325-6, 2009
Since December 2008, the Cleveland Clinic has disclosed on its Web site (www.clevelandclinic.org) industry ties of its 2000 physicians and researchers and their immediate families.  [The Center for Orthopedic and Neurosurgical Care and Research posts the potential conflicts of its physicians in patient examining rooms.]

Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov  
Bourgeois FT, Murthy S, Mandl KD  /  Ann Intern Med. 2010;153:158-66
An exhaustive evaluation of the industry vs. government vs. foundation supported phase 1, 2 and 3 drug trials reveals how potent the influence of the pharmaceutical industry is in conducting, reporting and promoting clinical trials of their agents

Enrolling Pregnant Women on Clinical Trials  
Goldkind S, Sahin L, Gallauresio B  /  NEJM 362(24): 2241-9. 2010
The categorical, blanket ineligibility of women on clinical trials who are, may be, or at risk of becoming pregnant has led to an orphaned group of human subjects in whom pharmacokinetics, pharmacodynamics, dosing, and optimal biologic doses are grossly unknown.  The recent H1N1 epidemic challenge highlights this dilemma.

Uniform Conflict Disclosures: Updated ICMJE COI Reporting Form  
Drazen JM, de Leeuw PW, Laine C, Mulrow C, DeAngelis CD, Frizelle FA, Godlee F, Haug C, Hebert PC, James A, Kotzin S, Marusic A, Reyes H, Rosenberg J, Sahni P, van der Weyden MB, Zhaori  /  NEJM 2010 (July 8);363:188-9

The Road to Amiens  
Steward D, Kurzrock R:  J Clin Oncol 27(3):228-33,2009
The auithors use a World War I analogy to content that progress against cancer and most other diseases has been slowed substantially by the clinical research efficacy bar having been set too low and consequently the safety bar having been set too high.  When little is to be gained, minimization of risks becomes paramount. Together these faulty efficacy and safety standards slow research progress while escalating costs.

Disclosing Industry Relationships — Toward an Improved Federal Research Policy  
Eric Campbell, PhD, Darren Zinner, PhD  /  N Engl J Med  /  August 12, 2010 363(7):606-7
The Affordable Care Act supports more rigorous disclosure of industry-physician relationships, including declaring and gift of $10 or more or a total gift receipt of $100 or more per year

How Clinical Trials Can Be Cost Neutral  
How clinical trials can be cost effective in Central Oregon  /  J Oncol Pract 5(2):76-9, 2009

Subject Recruitment and Retention Biases  
Goldfarb N:  J Clin Res Best Pract  3(11, Nov) 2007  [submitted by Meredith Dawson]
The potential biases in subject entry on clinical trials that result in non-generalizability of the study outcome are numerous and likely under-appreciated

Oregon 2005 Senate Bill 1025 Genetic Privacy  
Effective 2006, a person's tissue that may reveal DNA and other genetic information, is protected by this privacy act



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