Nine Strategies to Address High Placebo Response in Systemic Lupus Erythematosus (SLE) Clinical Trials
In systemic lupus erythematosus (SLE) trials, the placebo arm is never truly placebo; it reflects the clinical reality of background therapy distorting the signal. High placebo rates in lupus trials continue to be a major obstacle to detecting the statistical incremental value of an investigational product (IP). Enrolled patients randomized to placebo are virtually always […]
What Placebo Response Data in Atopic Dermatitis Trials are Actually Telling Us
Placebo response, which has emerged as an important determinant of interpretability and success in atopic dermatitis (AD) clinical trials, is frequently a predictable consequence of conducting high-quality clinical studies in a disease characterized by inherent variability over time. Modern AD programs increasingly acknowledge placebo response as a structural feature rather than an anomaly. Adaptive designs, […]
Placebo Response in Clinical Trials for Hidradenitis Suppurativa
Potential contributors to placebo rates in hidradenitis suppurativa (HS) clinical trials include underlying disease variability, the relative lack of efficacy of current therapies, and the requirement for rescue therapy and/or concomitant medications. More specifically, the contributors to placebo response lie in the difficulty in evaluating disease severity in HS, lack of non-physician or patient-assessed objective measures […]
Building Momentum in Clinical Trial StartâUp
Delays in site startâup remain one of the biggest obstacles to efficient clinical trial delivery, often caused by lengthy feasibility processes, protracted contract negotiations and poor communication between stakeholders. This International Clinical Trials article, written by Esther Sanchez, Associate Director, Start-Up at Indero, highlights practical insights on how to overcome these challenges through dataâdriven site […]
The Strategic Power of Public Relations in Scientific and Technical Industries
With 2 decades of experience in marketing across scientific, technical, and medical B2B sectors, Sarah Ballard, Agency Director at kdm communications, brings insight into the role of public relations (PR). Known for her strategic mindset and empathetic leadership, Sarah has helped numerous organizations navigate the complexities of integrated communications and build impactful PR campaigns. In […]
Rethinking CRA Oversight
With more than 25 years of experience in clinical research, Isabel Dorion, Senior Director of Clinical Operations at Indero, has played a pivotal role in advancing trials from phase I through IV. Her deep understanding of both site-level operations and the complexities of the CRO landscape positions her as a leader in driving operational excellence. […]
What Sites Look for in Sponsors: A Practical Checklist
The relationship between sponsors and investigative sites is more critical than ever. Sites are not just service providers, they are essential partners in delivering high-quality, efficient, and ethical clinical trials. Yet, many sponsors and CROs fall short in meeting site expectations, leading to operational inefficiencies, diminished motivation, and even site attrition.  Contributing their expert insights […]
Aligning With Patient Advocates in Trials
A strong commitment to patient-centered care has guided the work of the Polish Atopic Disease Association (PTCA), founded to support families affected by atopic conditions. One of the associationâs most impactful contributions has been the introduction of Wet Wrap Therapy in Poland, a technique that has helped thousands of patients manage symptoms more comfortably. This article […]
A Site-Centric Approach to Protocol Usability
Protocol usability is a critical yet often overlooked factor in clinical trial efficiency. Errors and inconsistencies within protocols and supporting documents can lead to confusion, operational delays, and protocol deviations at research sites. This article explores how a site-centric approach emphasizing clarity, integration, and operational feasibility can significantly reduce these issues and enhance trial execution. […]
Enhancing Representation: Strategies for Patient Centricity in Inclusive Clinical Trials
Regulatory bodies are increasingly emphasizing patient centricity in clinical trials, reshaping their design to prioritize patient needs and experiences. John Clarke, Associate Director of Patient Recruitment at Indero, leverages his extensive experience in clinical research and patient recruitment to navigate this evolving landscape. This discussion explores how new guidelines are enhancing patient involvement, ensuring diverse […]
