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J&J’s Clinical Data Disclosure Strategy Focuses On Collaboration With Yale University Group

 
• By Brenda Sandburg

In what appears to be the most expansive policy to date on release of clinical trial data, J&J will use an existing outside group and will share full clinical study reports and patient-level data regardless of when the studies were conducted.

Johnson & Johnson is joining the ranks of companies providing access to its clinical trial data. But it is taking a different approach to the process, leaving it to a group at Yale School of Medicine to review and make final decisions on requests from investigators and physicians for access to anonymized data.

J&J announced on Jan. 30 that it has entered into an agreement with Yale School of Medicine’s Open Data Access...

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• By Eliza Slawther

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The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

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Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

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UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

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• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

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• By Michael McCaughan

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