Newsletter | June 4, 2025

06.04.25 -- Take-Home Microdosing Trial Studies Sub-Hallucinogenic For Depression

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DECENTRALIZED TRIALS

Take-Home Microdosing Trial Studies Sub-Hallucinogenic For Depression

MindBio Therapeutics CEO Justin Hanka details the company’s Phase 2a clinical trial investigating the use of a take-home microdosing regimen for depression.

Regulatory Opportunities For Decentralized Clinical Trials

Project SHASTA, a pioneering effort to measure the benefits of decentralized trial elements, reveals significant regulatory opportunities that could shape the future of clinical research.

How Decentralized Clinical Trials Can Improve Data And Save Money

Decentralized clinical trials are revolutionizing research by accelerating timelines, improving data collection, and enhancing patient retention.

TRIAL MANAGEMENT

What's The Risk Of Letting Researchers Use LLMs?

Who should be using AI and how? Sage Therapeutics' Jake Alme explores AI use in clinical research, examining its use shifting toward more complex applications and discussing the risk of using it in the public domain.

Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology

Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

Achieving Person-Centricity In Clinical Trial Recruitment

Clinical trial enrollment remains a major bottleneck in drug development, but consumer-centric innovations could present a solution to enhance every stage of clinical trial enrollment.

Risk Mitigation Planning For Pharmaceutical Tariffs

Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.

Uncovering Common Rater Errors In Cognitive Assessments

Learn about frequent administration and scoring errors in MMSE and ADAS-Cog assessments during Alzheimer's trials and how data surveillance and targeted rater training can improve cognitive testing.

Factors Affecting Systemic Drug Exposure

The increasing number of drugs on the market leads to a greater potential for DDIs. Determining the extent of the interaction and associated risks is an important safety consideration.

Reviewing Protocols Across Therapeutic Areas

Get your clinical trial to the start line while ensuring participant health and safety. BRANY IRB provides a high-quality review, going above and beyond in the mission to protect research participants.

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You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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