IRB Featured Articles

1. The High Cost of Clinical Research – Who’s To Blame And What Can Be Done? 4/8/2013

   The cost of new drug discovery has skyrocketed in recent years, and is something that should have everyone in the drug discovery industry concerned. Sergei Varshavsky, M.D., Ph.D., and senior VP of global strategy for contract research firm Synergy Research Group (SynRG), notes it was not always this way. Some of the greatest medicinal discoveries in the history of mankind were inexpensive to develop and test. “There was the discovery of the smallpox vaccine in 1796, ether anesthesia in 1846, and insulin and penicillin in the early 20th century,” he says. “None of them cost much. In fact, the patent for insulin was sold to the University of Toronto for a half-dollar. Despite the low cost, these drugs have saved billions of lives.” Unfortunately today’s medical community is no longer able to accomplish similar feats for such a low cost.

2. Managing Clinical Risk For The Development Of Drugs And Devices 2/21/2013

   Managing regulatory risk in an environment of increasing regulatory scrutiny is a critical success factor to consistently develop and launch new products efficiently. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of clinical development through a review of regulatory trends for a period of 18 months.

3. Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees 2/12/2013

   This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert

4. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part II 1/22/2013

   Continuing with the review of the key points in FDA’s guidance.  This is the second of three postings. By Bart Cobert

5. Making Precompetitive Partnerships Work In Clinical Trials 12/28/2012

   J&J executives realized that to design the clinical trial process in the future they would have to look outside their walls and collaborate.

6. Pfizer Perseveres In Pioneering Virtual Clinical Trials 11/29/2012

   Craig Lipset discusses the lessons learned from Pfizer’s REMOTE clinical trial was conducted with less than stellar patient responses.

7. Strategic Application Of Regulatory Pathways For Medical Devices 11/15/2012

   The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) signed into law by President Obama last July is a sweeping piece of legislation that, among many other provisions, enacts reforms aimed at improving various FDA regulatory procedures, including the medical device review and approval processes.  By Evan L. Rosenfeld, MD, JD, FCLM, Vice President of Medical and Scientific Affairs, Medical Device and Diagnostics, Theorem Clinical Research

8. Clinical Trials Ontario: Harnessing Its Research Expertise 9/28/2012

   As clinical trial placements began to decline after 2008, Ontario became the first Canadian governmental entity to fund an organization to change the clinical trials landscape, Clinical Trials Ontario (CTO).

9. Considerations In Using Foreign Trial Data In U.S. NDA Submissions 8/3/2012

   More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services

10. Streamlining The Workflow of CRCs: Understand the Challenges, Provide Solutions 5/1/2012

    Clinical Research Coordinators (CRCs) play a crucial role at sites in ensuring that research is conducted in a GCP-compliant manner. In many cases, processes could be streamlined to foster greater efficiency and quality in operations. In order to improve the processes, the challenges of current workflows must first be understood.