Clinical Leader - Helping clinical research professionals connect and collaborate

Senior woman with caregiver-GettyImages-2151920853

Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.

GUEST COLUMNISTS

Caregivers: The Missing Line Item In Trial Budgets
More than 60 million Americans are caregivers, holding up a system and clinical research enterprise, yet they are mostly uncompensated for their efforts. That needs to change, says Denise N. Bronner and Marsha Calloway-Campbell.
A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis
A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).
Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
Reminder: FDA Approval Is Not Synonymous With Commercial Success
Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability.
What Sites, Sponsors, Vendors, And CROs Can All Agree On
Experts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.
AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.
Is It Time To Replace RECIST — Or Just Add AI?
Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
India Opens The Fast Lane For Drug Development
New in 2026, extensive reforms to India’s clinical trial rules are slashing approval timelines in half and eliminating licenses that once took months to obtain.

CLINICAL TRIAL WHITE PAPERS

Modernizing Clinical Trial Logistics To Deliver Value
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.

The Importance Of A Maturity Model For Clinical Trial Transparency
10/23/2024

A comprehensive maturity model for clinical trial disclosure and transparency offers companies a strategic tool to assess and enhance their practices in an increasingly complex regulatory environment.
Navigating The Complexities Of Clinical Trial Site Payments Forecasting
7/9/2024

Advanced technology and best practices have the potential to revolutionize clinical trial site payment forecasting, leading to significant improvements in overall trial efficiency and management.
The Complexities Of Effective Patient Retention In Clinical Trials
11/7/2025

Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.
Modernizing Clinical Trial Oversight: The Path To Clinical Operations Excellence
8/4/2025

Examine the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.
Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps
7/7/2025

Modernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

3-Week Database Builds That Withstood FDA Review
3/31/2026

Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.
FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study
3/12/2026

Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
Solutions To The Challenges Of Oncology Trials
5/6/2025

This significant Phase III trial, one of the largest global studies in head and neck cancer, faced considerable challenges including enrollment delays and an intricate study design.
Early-Stage Development In Rare Pediatric Oncology
4/11/2025

Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
Increasing Participation In World-Class Cancer Research In Northwest Arkansas
3/26/2026

Discover how data automation and integrated screening help community cancer centers offer clinical research as a standard care option, ensuring all patients have access to the latest treatments.
Duchenne Muscular Dystrophy Trial In China
9/17/2025

A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.

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.

Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.
Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials

Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)

In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.

FOCUS ON PATIENTS

Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.
Breaking Barriers In Rare Disease Clinical Trials

Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.
Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials

Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.