News & Analysis as of

Data-Sharing Clinical Trials

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Society of Corporate Compliance and Ethics...

[Event] Higher Education & Healthcare Research Compliance Conference - June 10th - 12th, New Orleans, LA

Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

Polsinelli

California Privacy Rights Act: Latest Update, Impact and Next Steps

Polsinelli on

The California Privacy Rights Act (CPRA) is a ballot initiative that, if passed in November, will significantly amend the California Consumer Privacy Act (CCPA)....more

Hogan Lovells

Medical Research Council Advises on How to Anonymise Information for Research Purposes

Hogan Lovells on

Anonymisation has always been (and still is) a real challenge for those carrying out clinical research. To shed some light on this matter, the Medical Research Council (MCR) – which is part of UK Research and Innovation – has...more

Hogan Lovells

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data...

Hogan Lovells on

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more

Troutman Pepper

Negotiating the Tension Between Transparency and Privacy

Troutman Pepper on

Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks. Originally published in Drug and Medical Device,...more

Morgan Lewis

Clinical Trial Data: The New Regime

Morgan Lewis on

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

K&L Gates LLP

Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

K&L Gates LLP on

The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

King & Spalding

Also In The News - Health Headlines - February 2015

King & Spalding on

House Committee Releases 21st Century Cures Discussion Document – On January 27, 2015, the U.S. House of Representatives Energy and Commerce Committee released a discussion document as part of its 21st Century Cures...more

Manatt, Phelps & Phillips, LLP

Health Update - January 2015

Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk - Editor’s note: At the request of 23 public and private sector sponsors—including major life sciences companies, as well as U.S. and international...more

Knobbe Martens

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

Knobbe Martens on

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)...more

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