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We take a closer look at some of the key stats in a new DCT report from the Partnership for Advancing Clinical Trials (PACT), a consortium hosted and facilitated by the Tufts Center for the Study of Drug Development (CSDD).

GUEST COLUMNISTS

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Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
The FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.
How Is RIM Software Transforming Regulatory Compliance?
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
Why CRA Proficiency Needs A Boost From Better Assessment And Training
CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.
EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025
Single Peptides & Pig Testing: How Longhorn's Developing Its Universal Flu Shot
CEO Jeff Fischer discusses Longhorn's long-acting universal flu vaccine, from its suitability for testing in pigs to overcoming vaccine hesitancy.

CLINICAL TRIAL WHITE PAPERS

Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations
This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

Bringing Clinical Trials To Everyone's Backyard
1/10/2025

Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay
6/17/2025

From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.
Cell And Gene Therapies Global Clinical Trial Landscape (2018-2022)
9/15/2023

Dive into how the advancements in technology are heralding a brighter future for patients worldwide, offering new hope and improved healthcare outcomes.
Navigating IDMP Through The Extended EudraVigilance Medicinal Product Dictionary
8/7/2024

Here, the authors explain why adherence to evolving requirements is essential for marketing-authorization holders (MAHs) to ensure compliance and maintain accurate product information.
A Guide To Digital Endpoints In Major Depressive Disorder
3/7/2025

The integration of digital health technologies (DHTs) in clinical trials for Major Depressive Disorder (MDD) is transforming how symptom severity and treatment efficacy are measured.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Streamlining Patient Recruitment With AI–Driven Site Identification
5/1/2025

This study highlights the use of an RWD-driven, AI-enabled recruitment models as a transformative strategy for clinical development in hard-to-recruit populations.
eClinical Platform Accelerates COVID-19 Treatment Trial By 2 Weeks
1/8/2024

Examine a COVID-19 treatment trial that utilized integrated EDC, eConsent, eCOA, RTSM, and TeleVisit solutions, all within a single platform, to address three critical challenges.
Data-Driven Physician Engagement For Ultra-Rare Diseases
2/3/2025

How can an effective partnership help you to utilize advanced data analytics to address the significant challenges of clinical trials centered around ultra-rare diseases?
Feasibility Insights In HR+/HER2 - Metastatic Breast Cancer
4/16/2025

This case study showcases how advanced analytics were used to streamline feasibility planning for a Phase II clinical trial targeting HR+/HER2- metastatic breast cancer as a second-line treatment.
Solutions Support Endpoint Reliability In Pediatric Rare Disease Trial
8/15/2023

Dive into this case study where a pharmaceutical sponsor running a trial for a new treatment for a rare pediatric disease employed solutions and services dedicated to enhancing endpoint reliability.
Accelerated Peptide Drug Development And Clinical Strategies
10/16/2023

Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

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.

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.
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.

FOCUS ON PATIENTS

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.
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.