ACDM News Item

FDA Announces New Initiative for Real-Time Clinical Trials

Date: June 23, 2026

The U.S. Food and Drug Administration (FDA) has announced a new initiative to support the implementation of real-time clinical trials, with pilot studies exploring how regulators can review clinical trial data as it becomes available.

For clinical data management professionals, the announcement highlights the increasing importance of high-quality, timely and well-governed data to support evolving approaches to clinical research.

Read the full FDA announcement to learn more about the initiative and its potential impact on the future of clinical trials: https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials

Explore More News

New MHRA Guidance

The MHRA have published new guidance on ‘Software and Artificial Intelligence (AI) as a . . .

FDA Guidance for Industry

The FDA has issued a final guidance to provide information on risk-based approaches to . . .

Guideline on computerised systems and electronic data in clinical trials

The European Medicines Agency (EMA) have published the new guidelines on computerised . . .

Welcome IROS – Insights Research Organization & Solutions as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome IROS – Insights . . .

Recommendation paper on decentralised elements in clinical trials

Following their meeting on 4 Oct, the EMA/HTAs and EC have published a recommendation . . .

Welcome George Clinical as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome George Clinical . . .

Welcome Clinion as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome Clinion as a . . .

Welcome ClinoSol Research as a new corporate member

The ACDM: Association for Clinical Data Management is delighted to welcome ClinoSol . . .

CTU DMEG Update

The CTU DMEG has been actively discussing common problems that data managers face in . . .

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management

The ACDM Regulatory Considerations have reviewed the Revision 1 to the ICH E8 Guidelines . . .

ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”

https://acdmglobal.org/wp-content/uploads/2022/04/ACDM_FDA_DHT.pdf

Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials

Dear Colleague, We have just launched our 8-week public consultation on proposals for . . .