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Home » Newsletters » Research Practitioner

Research Practitioner Subscribe

March 31, 2023

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  • March-April 2023 | Vol. 24, Issue 02
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State, International Laws Complicate Protection of Trial Participants’ Private Data

Clinical trials are all about the data, but when that data includes participants’ protected health information (PHI), researchers, study coordinators and other staff must ensure that they are compliant with a growing myriad of patient privacy laws and regulations.

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Trial Closeout Requirements Are Numerous and Detailed, Compliance Is Crucial

A clinical trial is far from done once the last trial participant completes the last visit and the database is locked; there’s still a long list of tasks and procedures to work through, from accounting for leftover investigational product to wrapping up final reports. Failing to conduct all of those closeout activities can put a site out of compliance with FDA regulations, IRB requirements, the contract with the sponsor or even their own established policies and procedures.

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FDA Shares Latest Thinking on Electronic Systems, Signatures and Records

Acknowledging the ever-evolving technological and clinical research landscape, the FDA has published a new draft question-and-answer guidance on using electronic systems, records and signatures in clinical trials, providing greater direction on validation, digital health technologies (DHT) and the applicability of regulatory requirements.

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EMA Provides Direction on Electronic Data, Computerized Systems

The European Medicines Agency (EMA) has published a comprehensive final guidance that offers general principles for specific computerized systems, processes and data in the areas of validation, user management, security and electronic data as well as computerized systems implemented at the site level.

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FDA Advises on Neovascular Age-Related Macular Degeneration Drug Trials

The FDA has published draft guidance on developing neovascular age-related macular degeneration drugs, offering recommendations on trial eligibility criteria, efficacy endpoints and trial design considerations.

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EMA Looks to Ease Move to CTIS with New Q&A Guidance

The European Medicines Agency (EMA) has issued a new question-and-answer document that clarifies requirements of the Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR).

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EMA Releases Pediatric Addendum to VTE Trial Guidelines

The European Medicines Agency has created an addendum to its current guidelines on trials of venous thromboembolism (VTE) treatments that is intended to help sponsors expand studies to pediatric populations.

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FDA Guidance Allows Alternative Data Sources for External Control Arms

The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance.

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FDA Provides Draft Guidance on Early Lyme Disease Drug Development

A new FDA draft guidance for sponsors developing drugs to treat early Lyme disease focuses on trial designs for treatment of erythema migrans, a rash that often appears as one of the first symptoms in the disease’s early stages.

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FDA Issues Final Guidance on Cannabis Clinical Research

The FDA has finalized guidance on trials of human drugs containing cannabis and cannabis-derived compounds, offering updated direction on federally authorized sources for cannabis and providing references to relevant quality considerations.

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FDA Guidance Recommends Evaluating Wider Range of Doses in Oncology Trials

Oncology drug trials should consider a wide range of dosages and how they impact a wide variety of participants, rather than immediately titrating patients up to the maximum tolerated dose (MTD), the FDA said in a new draft guidance.

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Upcoming Events

  • 12Apr

    The Participant Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

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