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:7/30/2015)... , July 30, 2015   Aratana ... pet therapeutics company focused on the licensing, development ... animals, today announced that its strategic partner VetStem ... dose confirmation study of AT-016, an adipose-derived allogeneic ... the treatment of osteoarthritis pain in dogs. ...
(Date:7/30/2015)... , July 30, 2015  Discovery Laboratories, ... it has received the second $1.0M tranche under ... Research (SBIR) grant valued at up to $3.0 ... aerosolized KL4 surfactant as a potential medical countermeasure ...  Discovery Labs was awarded an initial $1.0 million ...
(Date:7/29/2015)... , July 30, 2015 According to ... - Growth, Trends & Forecasts (2015-2020), , published by Mordor ... 30.25 billion by the end of 2020, with ... for more than 40% of the global market size. The ... a CAGR of 13.7% during the period of (2015-2020). ...
(Date:7/29/2015)... 2015  AsureQuality and Ubiquitome have agreed to ... in food and primary production sectors. The collaboration ... device, the Freedom4. AsureQuality provides quality ... supermarket shelf for producers, processors and Competent Authorities ... disease control and pest management and surveillance programmes. ...
Breaking Biology Technology:Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 2Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 3Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 4Aratana Therapeutics Announces Positive Pilot Field Study for AT-016 5Discovery Labs Receives $1.0 million under an SBIR Grant in Continuing Support of the Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury 2Discovery Labs Receives $1.0 million under an SBIR Grant in Continuing Support of the Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury 3Asia Pacific to Dominate the Global Stem Cell Market - Vericel Corporation, Ocata Therpeutics, Athersys Inc., Cryo-Cell International, Geron Corporation, StemCells, Inc. Among the Major Players 2Asia Pacific to Dominate the Global Stem Cell Market - Vericel Corporation, Ocata Therpeutics, Athersys Inc., Cryo-Cell International, Geron Corporation, StemCells, Inc. Among the Major Players 3AsureQuality and Ubiquitome Partner on Applications for Mobile Molecular Food Safety Testing 2
... YORK, May 15 Cadus Corporation (OTC,Bulletin Board: KDUS) announced ... Revenues for the first quarter of 2008 were $100,000, ... for the first quarter of,2008 was $207,996, compared to net ... in net loss can be attributed to a decrease in ...
... BEDFORD, Mass., May 15 Hologic, Inc. (Nasdaq:,HOLX) ... will be,presenting at the Citigroup Investment Research Global ... at the Hilton Hotel in New York,NY., ... live audio webcast of,Hologic,s investor presentation on Thursday, ...
... and BARCELONA, Spain, May 15 Forest,Laboratories, Inc. ... (ALM.MC),will host a webcast to discuss aclidinium bromide ... Thoracic Society Annual Congress.,The webcast, which will include ... on Wednesday, May 21, 2008 at 9:30am New ...
Cached Biology Technology:Cadus Reports First Quarter 2008 Results 2Cadus Reports First Quarter 2008 Results 3Forest Laboratories, Inc. and Laboratorios Almirall, S.A. to Host Webcast to Discuss Aclidinium Bromide Data Presentations at the American Thoracic Society Annual Congress 2
(Date:7/31/2015)... 2015 BGI llevará a cabo la 10ª Conferencia ... 25 de octubre de 2015, en Shenzhen, ... décimo aniversario este año. Desde su inauguración en 2006, ... anuales más influyentes del mundo en los campos de ... más dinámicas, entusiastas y amenas. ICG-10 se ...
(Date:7/31/2015)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" or ... growing mobile commerce market and creator of the Wocket® ... 62/198989 for ELECTRONIC CRYPTO-CURRENCY MANAGEMENT METHOD AND ... advance crypto-currencies such as Bitcoin into the consumer market ... to manage all payments.  The technology ...
(Date:7/23/2015)... Aware, Inc. (NASDAQ: AWRE ), a leading ... for its second quarter ended June 30, 2015.  ... million, a decrease of 33% compared to $6.8 million in ... quarter of 2015 was $0.3 million, or $0.01 per diluted ... share, in the same period a year ago.  ...
Breaking Biology News(10 mins):La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 3NXT-ID Patents Electronic Crypto-Currency Management Technology 2NXT-ID Patents Electronic Crypto-Currency Management Technology 3NXT-ID Patents Electronic Crypto-Currency Management Technology 4Aware, Inc. Reports Second Quarter 2015 Financial Results 2Aware, Inc. Reports Second Quarter 2015 Financial Results 3Aware, Inc. Reports Second Quarter 2015 Financial Results 4Aware, Inc. Reports Second Quarter 2015 Financial Results 5Aware, Inc. Reports Second Quarter 2015 Financial Results 6
... today announced a series of important changes ... anti-inflammatory class of drugs, including COX-2 selective ... NSAID medications. A list of these products ... , "Today's actions protect and advance the ...
... and life-sustaining series of steps by which hematopoietic stem cells ... white blood cells and platelets has now been discovered to ... This finding, from an investigator at St. Jude Children's Research ... , Mcl-1 blocks the biochemical cascade of reactions that trigger ...
... Massachusetts General Hospital (MGH) has identified 80 new genes ... powerful new research tool for inactivating genes in plants ... find new genes that participate in the gene-silencing mechanism, ... report will appear in the journal Science and is ...
Cached Biology News:FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 2Protein That Promotes Survival Of Stem Cells Might Be Key To Poor Leukemia Prognosis 2Protein That Promotes Survival Of Stem Cells Might Be Key To Poor Leukemia Prognosis 3Scientists identify genetic pathways essential to RNA interference 2Scientists identify genetic pathways essential to RNA interference 3
Fingerprinting II comparative quantification and polymorphism analysis is an optional module that adds comparative quantification and polymorphism analysis functions to the Fingerprinting II Basic so...
... Ideal for hand-held applications or for ... II with a hand-held eight-port disposable manifold ... than a multi-channel pipette. The StatMatic II ... bottle sizes and can completely fill a ...
... The DNA Engine Tetrad thermal ... beyond the pioneering PTC-200 DNA Engine ... times the capacity with a footprint ... high throughput for laboratories that run ...
The PROTEAN II xi multi-cell 2-D conversion kit converts the PROTEAN II xi multi-cell to the PROTEAN II XL multi-cell for a wider format cell that accepts 17 to 18 cm IPG strips....
Biology Products: