Search results for Clinical Trial Data

<![CDATA[The Difference Between Real-Time Clinical Data Review and Real-Time Clinical Trial Oversight]]>

FDA Announces Real-Time Clinical Trial Pilot Program and Proof-of-Concept Studies with AstraZeneca and Amgen

What You Should Know The FDA has launched two proof-of-concept (PoC) real-time clinical trials (RTCT) that report endpoints and data signals to the agency as they occur. AstraZenec...

<![CDATA[ What Design Choices Made the MajesTEC-3 Trial Clinically Compelling?]]>

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

<![CDATA[Eli Lilly Releases Updated Safety Data for Foundayo Following FDA’s Request ]]>

FDA announces real-time clinical trials, request for information

The Food and Drug Administration April 28 announced its plan to advance the implementation of real-time clinical trials, which invite participants to supply reports and data to the...

Pragmatic Trials

Publisher: The New England Journal of Medicine Published: 2016 This analysis explains the methods used for trials that inform a clinical or policy decision by providing evidence...

FDA Moves Toward Real-Time Clinical Trial Modernization

On April 28, 2026, the U.S. Food and Drug Administration (“FDA”) announced additional steps in its ongoing initiative to advance real-time clinical trial approaches, including proo...

FDA Sends Notices to More Than 2,200 Sponsors Regarding Unpublished Clinical Trial Results

The U.S. Food and Drug Administration (FDA) announced on April 13, 2026, that it sent reminder letters to more than 2,200 drug, biologic, and medical device companies and researche...

FDA urges clinical trial sponsors to report the results of their studies

An FDA review of records found that results have not been reported for 30% of registered clinical studies. To remedy this shortfall, the U.S. regulator has sent reminders to 2,200...

China’s National Medical Products Administration Releases Implementation Measures for Drug Trial Data Protection – May 3...

On May 15, 2026, China’s National Medical Products Administration (NMPA) released the Implementation Measures for Drug Trial Data Protection (药品试验数据保护实施办法), effective M...

New method confirms positive clinical trial results for MS drug Tecfidera

A new method called target trial emulation (TTE) used real-world data to successfully replicate the findings of a previous clinical trial of Tecfidera (dimethyl fumarate) involving...

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

WEDNESDAY, April 29, 2026 — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon...

<![CDATA[Pharmaceutical Executive Daily: Eli Lilly Releases Updated Safety Data for Foundayo]]>

Clinical trial flaws ‘being scaled, not solved’ by AI: report

Clinical trial data company Phesi’s new analysis found that fewer than one in three trial protocols are connected to documented patient data and outcomes, highlighting the risk tha...

in this issue

Applying data from clinical trials is intrinsically problematic because the benefits of an intervention are presented as group averages and do not describe how an individual patien...

F.D.A. Pushes Drug Developers to Report Clinical Trial Results

Many unfavorable results go unreported, skewing the available data on medical treatments.

Pliant presents updated cancer trial data at AACR meeting

FDA Makes Moves to Modernize Drug Development, Clinical Trial Paradigm

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” I...

Real-time trials may ‘fundamentally transform’ research

An FDA initiative to implement real-world clinical trials could dramatically accelerate the pace at which new treatments become available to patients, according to physicians from...

FDA unveils plan for real-time review of clinical trial data, with AstraZeneca and Amgen already on board

The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with two major industry players already taking part in a pi...

ATS: phase 2 data demonstrate the superiority of efdoralprin alfa over a standard-of-care augmentation therapy in achiev...

- - • Data from the head-to-head study show efdoralprin alfa normalized and maintained functional AAT levels in people living with alpha-1 antitrypsin deficiency - • Efdoralpr...

<![CDATA[Does FDA's Shift From Two Pivotal Trials to One Represent a Genuine Evolution?]]>

<![CDATA[The Risks and Benefits of FDA Reviewing Real-Time Data]]>