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

izations of a product's safety and effectiveness, as well as open up new avenues of scientific inquiry beyond the scope of the original study. However, there are concerns that research participants' identities could be discovered, and that competitors and others could use the data to produce flawed analyses. The FDA historically has treated participant-level clinical trial data submitted to the agency as confidential.

The authors recommend that a system of expanded access to clinical trial data apply to trials of all approved prescription drugs, medical devices, and biologics; and treat all trial sponsors and qualified data requesters evenhandedly. It should have mechanisms to ensure that all sponsors and data users adhere to minimum standardsfor example, rules should specify what must be shared, and data users should commit to following a scientifically sound analytical plan. If sponsors are permitted to influence which data requests get granted, they should be required to apply explicit decision criteria and publicly explain the reasons for denials. Using an independent intermediary organization to make those decisions, however, may be preferable.

"As in other areas of health care, the push for greater transparency in the area of clinical-trial data appears inexorable," the authors wrote. "The question is not whether, but how, these data should be broadly shared. The potential risks to research participants and trial sponsors must be thoughtfully addressed in the design of any new data-sharing system but need not block progress toward achieving the promise of 'big data' in the clinical trials context."

"The European Medicines Agency has hastened to impose regulatory mandates for data sharing, which may indeed be needed," said Mark Barnes, a partner at Ropes & Gray LLP and the Harvard faculty co-director of MRCT, "but such mandates need to be carefully considered, to avoid harms to participants and to preserve commercial incentives for i
'/>"/>

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:7/23/2014)... 23, 2014 Shimadzu Scientific Instruments ... acid analysis system developed jointly with Ajinomoto Co. ... can analyze 38 amino acids in nine minutes, ... achieves high-speed analysis utilizing a fast application-specific column ... accurate analytical results even under conditions with difficult ...
(Date:7/23/2014)... AVIV, Israel , July 23, 2014 /PRNewswire/ ... ., a portfolio company of Trendlines Agtech ... one of Israel,s leading ... http://photos.prnewswire.com/prnh/20140121/666259-a) , Valentis,s technology combines nanocrystalline ... plant pulp waste, with additional nanoparticles to produce ...
(Date:7/23/2014)...  GrowBLOX Sciences, Inc. (OTCQB: GBLX), a medical cannabis research ... two medical marijuana dispensary locations in Las Vegas, ... Clark County, Nevada dispensary for which ... announced.  GrowBLOX Sciences, CEO Craig Ellins ... for dispensaries in the City of Las Vegas ...
(Date:7/23/2014)... a2z Inc. announces that AACC will ... Pathfinder, in its 2014 Annual Meeting & Clinical ... planned for July 29-31, 2014 in Chicago, IL at ... connect with global leaders in clinical chemistry, molecular diagnostics, ... of breaking science in laboratory medicine. , ChirpE Photo ...
Breaking Biology Technology:Shimadzu's New UF-Amino Station Provides High-Speed, Multi-Component Analysis of Amino Acids in Food & Beverage and Pharmaceutical Testing 2Valentis Nanotech Signs MOU to Integrate Technology in Thermoplastics Production 2GrowBLOX Sciences, Inc. Files for Two Additional Medical Marijuana Dispensaries in Las Vegas 2GrowBLOX Sciences, Inc. Files for Two Additional Medical Marijuana Dispensaries in Las Vegas 3AACC Enhances Attendee Experience at Its 2014 Annual Meeting & Clinical Lab Expo with a2z-Powered ChirpE Photo Booth and Mobile App 2AACC Enhances Attendee Experience at Its 2014 Annual Meeting & Clinical Lab Expo with a2z-Powered ChirpE Photo Booth and Mobile App 3
... agree that the promise of nanotechnology is great, but there ... , The new technology, which is making its way ... seen differently among scientists than the general public, with scientists ... broad categories of risk versus reward both groups seem to ...
... Combination of Two Proven Therapies that Significantly Raises ... ... Cholesterol, ABBOTT PARK, Ill., Feb. 15 ... first fixed-dose combination of two widely prescribed cholesterol,therapies, Niaspan(R) (Abbott,s proprietary ...
... ("PAREXEL") (Nasdaq: PRXL ) notes the recent movement ... "Company"). Under the,United Kingdom Takeover Code, PAREXEL confirms that ... ClinPhone in relation to a potential,offer by PAREXEL for ... of,ClinPhone. While that preliminary proposal was rejected by the ...
Cached Biology Technology:Nanotech's health, environmental impacts worry scientists and the public 2Nanotech's health, environmental impacts worry scientists and the public 3Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management 2Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management 3Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management 4Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management 5Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management 6Announcement in Relation to the Movement in the ClinPhone Share Price 2Announcement in Relation to the Movement in the ClinPhone Share Price 3Announcement in Relation to the Movement in the ClinPhone Share Price 4
(Date:7/23/2014)... MA -- What do mollusks, starfish, and corals ... habitat, they are all calcifiersorganisms that use calcium ... and shells for stability and protection. , The ... published by the Marine Biological Laboratory, addresses the ... changes worldwide. , As atmospheric carbon dioxide rises, ...
(Date:7/23/2014)... nasty habit of getting tangled and forming knots. Scientists ... how to disentangle them (e.g. useful for gene sequencing ... Advanced Studies (SISSA) in Trieste and his team have ... knots and their dynamics. In their latest paper, just ... together with Marco Di Stefano, first author and PhD ...
(Date:7/23/2014)... Currently, no cure exists for Alzheimer,s disease, the ... Americans. But scientists are now reporting new progress ... cancer treatment, that shows promise as a potential ... ACS, Journal of Medicinal Chemistry . , ... that in a healthy brain, the protein known ...
Breaking Biology News(10 mins):Calcification in changing oceans explored in special issue of The Biological Bulletin 2
... like hype from a late-night infomercial: It can twist ... could someday help you fend off disease! But ... several institutions including the U.S. Department of Energy,s Lawrence ... the cell,s protein-making machine, the ribosome, at key stages ...
... available in Spanish . , After corn ... looks something like slightly dampened cornmeal, though a somewhat darker ... grains with solubles" (WDGS), this byproduct is sometimes used as ... in Clay Center, Neb., are studying the pros and cons ...
... Researchers from the University of Iowa Roy J. ... that inhaled carbon black nanoparticles create a double source ... published online in the April 27 edition of the ... UI professor of internal medicine, was lead author of ...
Cached Biology News:Atomic-scale structures of ribosome could help improve antibiotics 2Atomic-scale structures of ribosome could help improve antibiotics 3Studies focus on feed ingredient's effects on levels of E. coli O157:H7 in cattle 2Carbon black nanoparticles can cause cell death 2
... A full-featured high-performance ICP-MS system designed for ... interface, Omega II off-axis ion lens, true ... 7500a can handle the widest range of ... the 7500a now includes as standard Agilents ...
... that it uses a deep-UV deuterium bulb, which ... with a shutter (controlled via a TTL signal ... DH-2000 Deuterium Tungsten Halogen Light Source combines ... light sources in a single optical path. The ...
One controller two vessel system suitable for early stage of fermentation, and small scale, Application : cultivation of microorganisms and human or animal cells...
... space and organize gloves, safety glasses, ... are the perfect benchtop storage bins ... processing and manufacturing. Clear static-dissipative PVC ... they attract. Many other sizes and ...
Biology Products: