Posted by Michael Jay on Fri, Oct 21, 2011
RxTrials welcomes Diana Caldwell with Pearl Pathways as a guest blogger who wrote the below post:
Health and Human Services announced in July a proposal to improve provisions of the Common Rule. This set of regulations has remained basically unchanged since the ‘80s. See the proposed changes in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. Clearly, the agency wants more feedback. The original deadline was September 26th and now the deadline has been extended until Wednesday, October 26, 2011. These rules impact many aspects of the research we do each day, so we encourage our readers to review the proposed changes and provide commentary here. Learn more on the HHS site.
Last week at the Site Solutions Summit, many of us heard Ken Getz’s thoughts on implications of these changes. Some of the most interesting changes are noted below:
- Requiring the use of a central IRB for multi-site studies
- Updated content regarding informed consents, and proposed limitations on length
- Unifying consent requirements for the use of biospecimens in studies
Submit your comments now at www.regulations.gov and use the identification number HHS-OPHS-2011-0005.
Posted by Michael Jay on Wed, Sep 14, 2011
RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Integrated CRO alliances growing but poorly executed” by Karyn Korieth, which appears in The CenterWatch Monthly September 2011 issue.
Results from a new CenterWatch survey show CROs believe that while the prevalence of integrated alliances with sponsors will grow in the next three to five years, many sponsors fall short when managing these more sophisticated relationships. more...
Posted by Michael Jay on Thu, Sep 01, 2011
Written by Adam Chasse, Vice President, Corporate Development at RxTrials
Source:HHS cutting red tape to speed clinical trials
American Medical News
HHS’s proposal to require protocol approval by a single central IRB could trim study startup timelines, particularly for indications more likely to be studied in academic and hospital settings. If enacted, this will be one critical step in accelerating drug development. But as with all new policies, there will be benefits to some stakeholders and detriments to others – all of which may make for some interesting lobbying. more...
Posted by Michael Jay on Wed, Aug 24, 2011
RxTrials welcomes Gregory Osgood, Director of Clinical Research Operations at Delta Waves Sleep and Research Centers as a guest blogger who wrote the below post:
Clinical development still looks like a series of free-for-alls that can easily cause failures. Meanwhile, costs and time invested climb like our national debt. There is pressure on sponsors, CROs and sites to do better. No one is happy about how things are going. There is plenty of upside for improvement. more...
Posted by Michael Jay on Wed, Aug 03, 2011
RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Sponsors target new areas to speed cycle times” by Karyn Korieth, which appears in The CenterWatch Monthly August 2011 issue.
Across the industry, biopharmaceutical company executives struggle to find ways of shortening drug development cycle time.
In the current drug development environment, sponsors place a high priority on accelerating cycle time to improve R&D productivity. more...
Posted by Michael Jay on Wed, Jul 13, 2011
RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Sponsors question variations in overhead rates: More push-back means sites may have to justify how much they charge” by Karyn Korieth, which appears in The CenterWatch Monthly, July 2011 issue.
Few issues provoke more interest in clinical trial grant negotiations than overhead rates. more...
Posted by Michael Jay on Wed, Jun 08, 2011
RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Sites rate Novo Nordisk, Roche, Amgen on top” by Karyn Korieth and Annick Anderson, which appears in The CenterWatch Monthly, June 2011 issue.
A new CenterWatch survey shows sponsors have improved their relationships with investigative sites during the past three years as they increasingly focus on strategies to improve site quality and performance. Yet the average sponsor continues to fall below the performance expectations of sites in several critical areas, including project management and study initiation activities. more...
Posted by Michael Jay on Wed, Jun 01, 2011
RxTrials welcomes Gretchen Bowker with Pearl IRB as a guest blogger who wrote the below post:
In March 2011 FDA finalized guidance on exception of informed consent requirements for emergency research. Emergency research involves the most vulnerable population of study subjects, i.e., a population with no capacity to control what happens to them and no capacity to consent, in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject’s legally authorized representative. more...
Posted by Michael Jay on Tue, Apr 12, 2011
RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from writer Karyn Korieth’s article “Liability Demands Putting Sites at Risk,” which appears in The CenterWatch Monthly, April 2011 issue.
Liability. Indemnification. Risk. These have emerged as the new four-letter words of clinical trials.
As sites increasingly are being asked to indemnify drug sponsors in order to participate in a clinical study, liability issues have moved to the forefront. more...
Posted by Michael Jay on Wed, Mar 23, 2011
As Director of Business Development for Rx Trials, I am responsible for acquiring new study opportunities for all of our sites and for ensuring that each site has enough appropriate trials to sustain their operation. In the past several months, my curiosity has been peaked, about the concept of study brokers. In speaking with many sites I have learned many sites have actually used study brokers in an attempt to increase their study opportunity, however, I’m also not hearing that the results have matched the promise. more...