Navigation Links
Harvard researchers, pharma experts offer recommendations to expand access to clinical trial data
Date:10/22/2013

Boston, MA A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients' privacy and weighing pharmaceutical companies' business interests. Recently, the European Medicines Agency (EMA) announced it will provide public access to participant-level data submitted in applications for marketing approval in Europe, prompting questions about whether the U.S. Food and Drug Administration should follow suit. Data releases by the EMA have spurred litigation by drug companies and heated debate about whether clinical trial data should be protected as proprietary information or widely shared.

The report, published online October 21, 2013 in The New England Journal of Medicine, was released to coincide with the first meeting of the Institute of Medicine's Committee on Strategies for Responsible Sharing of Clinical Trial Data on October 23. The Institute of Medicine convened the committee on an accelerated timetable to develop a framework for expanded public access to clinical trial data. An initial report is expected in January 2014.

"Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data," said Michelle Mello, professor of law and public health at the Harvard School of Public Health and lead author of the report. "The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants' privacy, avoiding 'junk science,' and minimizing burdens on trial sponsors?"

According to the authors, expanding access to participant-level data could both serve as a check on trial sponsors' character
'/>"/>

Contact: Marge Dwyer
mhdwyer@hsph.harvard.edu
617-432-8416
Harvard School of Public Health
Source:Eurekalert

Page: 1 2 3

Related biology technology :

1. Genia Technologies, Columbia University, and Harvard University Awarded $5.25 Million Grant from NIH to Accelerate the Development of NanoTag DNA Sequencing Technology
2. Jeffrey Epstein, Science Financier, Changes the Course of Evolution at Harvard
3. Director of Proteomics at the Broad Institute of MIT and Harvard, Steven Carr, to Deliver Pittcon 2014 Wallace H. Coulter Plenary Lecture
4. Life Technologies Signs License and Collaborative Stem Cell Research Agreement with Harvard University
5. Harvard Wyss Institutes Lung-on-a-Chip wins prize for potentially reducing need for animal testing
6. Harvards Wyss Institute team creates versatile 3d nanostructures using DNA bricks
7. Harvards Wyss Institute models a human disease in an organ-on-a-chip
8. UMass Amherst, Harvard experts say better systems needed for medical device cybersecurity
9. Harvards Wyss Institute creates living human gut-on-a-chip
10. Harvards Wyss Institute develops DNA nanorobot to trigger targeted therapeutic responses
11. Niels Bohr Institute gets top researcher from Harvard
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... (PRWEB) December 17, 2014 Gene ... that it has entered into a technology access ... (ADM) to apply DNA2.0’s proprietary protein engineering technology, ... process. , “We are extremely excited that the ... platform. This proprietary bioengineering technology has now ...
(Date:12/17/2014)... SOUTH SAN FRANCISCO, Calif. , Dec. 17, ... positive results of a Phase 2 study evaluating ... for the treatment of patients with severe, chronic ... the current standard of care, including topical steroids ... endpoint was percent change in Visual Analog Scale ...
(Date:12/15/2014)...  GlassesOff Inc. (OTCBB: GLSO) announced today the appointment ... director of the Company,s Board of Directors. ... its CEO until its acquisition by Stanley Black ... Recognized as the inventor of the first Wi-Fi-based Active ... -based RFID solutions focused on improving operational efficiency, safety ...
(Date:12/13/2014)... (PRWEB) December 12, 2014 Clarassance, a ... announced its new name: Therabron Therapeutics , Inc. ... and bronchioles (a type of structure in the lungs ... company’s mission to develop novel protein therapeutics for the ... directors decided to change the name to mark the ...
Breaking Biology Technology:ADM and DNA2.0 Enter Into Protein Engineering Technology Access and Service Agreement 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 2Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 3Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Phase 2 Results for VPD-737 in Patients With Chronic Pruritus 4AeroScout Founder Joins GlassesOff's Board of Directors 2AeroScout Founder Joins GlassesOff's Board of Directors 3Maryland-based Biotech Company's Path Forward in Treating Respiratory Diseases Sparks Name Change 2
... - Mercedes Walton, Chairman and CEO of Cryo-Cell International ... Fla., March 17 As the CEO of Cryo-Cell ... bank, Mercedes Walton has been an active participant in ... She has seen first-hand the changes that have taken ...
... Spiral Biotech, an Advanced Instruments company, will ... -- which delivers faster cycle times, a ... processing speed and efficiency in microbiology laboratories -- ... Meeting in May, 2009."The introduction of the new ...
... Ferring Pharmaceuticals Inc., a specialty pharmaceutical company, ... to Senior Vice President of the Ferring International ... for Ferring Pharmaceuticals Inc. Dr. Korner was ... Orthopaedics, Urology, and Gastroenterology therapeutic areas, as well ...
Cached Biology Technology:Stem Cell Industry Insider Mercedes Walton Discusses President Obama's Stem Cell Executive Order 2Stem Cell Industry Insider Mercedes Walton Discusses President Obama's Stem Cell Executive Order 3Spiral Biotech to Introduce New Autoplate Spiral Plating System at ASM General Meeting in May 2Spiral Biotech to Introduce New Autoplate Spiral Plating System at ASM General Meeting in May 3Dr. Paul Korner Promoted to Senior Vice President of Ferring International PharmaScience Center U.S. 2
(Date:12/4/2014)... , Dec. 3, 2014  Crossmatch™, a ... announced that its DigitalPersona ® Pro Enterprise ... have been deployed throughout First Bank branch locations ... South Carolina and Virginia. First Bank, ... Southern Pines, North Carolina , selected ...
(Date:11/21/2014)... MOUNTAIN VIEW, Calif. , Nov. 20, 2014 /PRNewswire/ ... for higher driver efficiency are piloting the North American ... the number of accidents growing, gesture recognition systems that ... will make a mark in the industry. ... of the Automotive Gesture Recognition Market in ...
(Date:11/18/2014)... BETHESDA, Md. , Nov. 17, 2014 The ... European and U.S. regulatory agencies will speak and at least ... Quality Metrics Conference at the Omni Shoreham Hotel in ... is pleased once again to have significant support from the ... and Europe in our effort to ...
Breaking Biology News(10 mins):First Bank Partners with Crossmatch to Increase Log In Security 2First Bank Partners with Crossmatch to Increase Log In Security 3Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 2Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 3Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 4FDA's Janet Woodcock, EMA's Emer Cooke Headline PDA Quality Metrics Conference 2
... press release is available in French . ... Laval researchers and their colleagues from the Canadian Forest Service ... and fir has remained very much the same for over ... between today,s conifers and fossils dating back to the days ...
... Rochelle, NY, December 13A leading scientific society of university ... research in the sciences and technologies of environmental protection, ... (AEESP) , has selected the peer-reviewed journal ... Environmental Engineering Science is read around the ...
... animal cell is like a small city, with factoriescalled ... life functions. A network of intercellular "highways," called microtubules, ... speedily about the cell to keep this vital machinery ... Proceedings of the National Academy of Sciences ...
Cached Biology News:Your Christmas tree and its genome have remained very much the same over the last 100 million years 2Association of Environmental Engineering and Science Professors name Environmental Engineering Science as its official journal 2Study sheds light on how cells transport materials along crowded intercellular 'highways' 2Study sheds light on how cells transport materials along crowded intercellular 'highways' 3
...
Whole blood is collected from healthy guinea pigs of either sex from US source which are free of visible diseases at time of blood collection. Hemolytic titer: CH50 = 435 units...
... l-[35S]in vitro cell labeling mix, ... *Aqueous solution stabilized with 0.1% ... pyridine 3,4-dicarboxylic acid. *Amino acid ... labeling containing l-[35S]Methionine and l-[35S]Cysteine. ...
...
Biology Products: