Clinical Leader - Helping clinical research professionals connect and collaborate

AI technology regulations and ethical standards-GettyImages-2176362964

Clinical Trials Get A Council For AI Oversight

AI in clinical trials is moving fast — but without clear standards for ethics, transparency, or oversight. Advarra's new Council for Responsible Use of AI in Clinical Trials aims to change that. Founding members Sanofi, Recursion, and Velocity Clinical Research are stepping up to define what “responsible” really looks like.

GUEST COLUMNISTS

Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What
What do air traffic control, nuclear power plants, and aircraft carriers have in common? Patient recruitment expert Tatty Scott argues clinical researchers should look at these industries to inspire more precise trial execution.
Breaking Free From The Acronym Soup: Rethinking The Role Of Technology In Clinical Trials
Ascendis Pharma's Ivanna Rosendal details how clinical systems hinder clinical trial execution and why we should rethink how technology can support our trials.
Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials
Gilead’s Carrie Frenette discusses the company's art campaign centered on primary biliary cholangitis to bring awareness to the condition and create more patient-centric trials for patients.
Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy
Medicine is not one-size-fits-all. Here, strategic advisor Bill Hanlon implores pharma to develop therapeutics and diagnostics anchored by racial and ethnic diversity.
It's Time To Change How We Engage Research Sites
Site operations expert Maria Ladd argues for a major change in how sponsors and CROs communicate and work with clinical research sites.
The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management
Market expert Mathini Ilancheran explains how sponsors can mitigate the effects of "Most Favored Nation" drug pricing while maintaining trial integrity and accelerating time to market.
Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.

CLINICAL TRIAL WHITE PAPERS

Operationalizing Disclosure Intelligence For Compliance At Scale
Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.

Driving ROI Through Patient Convenience Solutions
2/16/2024

Uncover the findings from this third-party ROI analysis firm that conducted interviews with customers to assess their experiences using Greenphire's Participant Reimbursement and Travel Solutions.
Disclosure Management System: Build Or Buy?
6/19/2025

Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
Maximizing Efficiency: A Comprehensive Guide To Study Coordination Services
1/14/2025

Explore the critical role of study coordinators, emphasizing their expertise, strategic contributions, and the value they add to clinical research.
Looking Beyond Weight Loss In The Obesity Pandemic: What's Next?
7/12/2024

Here, we analyze the current landscape of obesity management, underscoring the critical need for comprehensive approaches that prioritize overall well-being beyond simple weight reduction.
Infectious Diseases – 2018-2023 Global Clinical Trial Landscape
11/7/2023

Gain in-depth insights into infectious diseases-based clinical trials and be better informed about trends, regional disparities, technological advancements, and financing dynamics.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Transforming Invoice And Payment Processes While Reducing Costs
1/18/2024

Uncover how Uni Hospital, a state-of-the-art medical center in Bulgaria was able to process invoices and receive payments quicker while noticeably improving accuracy.
A Thoughtful Copay Program Design That Increased Patient Engagement
11/26/2024

Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.
Breakthrough Therapy Designation Accelerates Oncology Treatment Development
10/24/2023

Find out how this evidence-generation company's solutions and scientific expertise enabled early and successful regulatory submission for a novel oncology therapeutic.
Best Practices For Changing From One eClinical Vendor To Another
10/24/2023

Switching solution providers mid-study isn't uncommon. But how can teams avoid schedule delays, interrupted operations, and errors? Learn best practices from this example by Signant Biotech.
Data Management Solution For A Clinical-Stage Cancer Immunotherapy Study
7/23/2024

Check out the results from a clinical first-in-human study evaluating the safety and tolerability of an investigational cancer immunotherapy in patients with advanced melanoma.
Effective Recruitment Capabilities And Outstanding Customer Service
6/10/2025

Hear from many customers who commend OpenClinica's effective recruitment capabilities, outstanding customer service, and adept problem resolution.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

RECRUITMENT AND DIVERSITY

This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.

Imunon Talks Passionate PIs, Endpoint Selection In Frontline Ovarian Cancer Trials

IMUNON CEO Stacy Lindborg, Ph.D. details the company’s successes in site selection, as well as trial design and execution, in Phase 2 and 3 trials for IMNN-001, a frontline treatment for ovarian cancer.
Dear Pharma, The Creator Economy Is NOT Only For Beauty

Empactful Ventures CEO Denise N. Bronner has a message for pharma when it comes to influencer marketing: Adapt or become invisible. Here, she details the hazards of overlooking this powerful media channel.
Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research

CEO Marc Deschamps shares how ischemic stroke treatment has overshadowed that of intracerebral hemorrhage, negatively impacting recruitment for ICH clinical trials. To turn the tide, he advocates for accurate diagnoses, more specialized care, and less restrictive enrollment criteria.

FOCUS ON PATIENTS

From Protocol To People: Teva's Patient-First Clinical Trials Approach

Teva Pharmaceuticals' Head of Global Early Clinical Development Eran Harary, MD, shares how the company approaches drug development by getting patient input early and often.
2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets

Vibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.
Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials

Gilead’s Carrie Frenette discusses the company's art campaign centered on primary biliary cholangitis to bring awareness to the condition and create more patient-centric trials for patients.