02.16.21 -- How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher

The global pandemic has exacerbated the operational challenges intrinsic to gene therapy at the site level, the project team level, and the sponsor level. To ensure that studies continue to move forward, strategies need to be considered not only for operational efficiency and patient-centricity, but also as contingency planning in the case of a subsequent wave or quarantine.

Designing and conducting a gene therapy trial is a complex undertaking. Understanding, planning for, and overcoming the myriad of challenges of operationalizing these studies will help bring safe, breakthrough treatments to patients with unmet medical needs. This case study provides a framework for exploring the critical study design considerations of gene therapy trials and offers strategies for addressing those hurdles.

In a new and extremely competitive era, there is more pressure than ever to optimize your clinical development strategy and planning for successful study recruitment, retention, and implementation. This article, based on a recent webinar, explores critical study design and operational success factors for the new wave of dermatology clinical trials.

Today’s technology enables us to seamlessly integrate data for every stage of a clinical trial, from lab results to mobile health apps, patient-reported data, and much more. These new sources of data allow us to better interpret, predict, and quickly turn around a study that may be stalled due to lagging enrollment, regulatory challenges, or patient safety. View this video to learn how to bring study data and data quality processes together under one platform.

There is a longstanding debate on the use of placebo control in clinical trials. Critics argue that it sacrifices the welfare of patients and is unethical if a proven therapy exists. Proponents argue that placebo control is crucial for proving the safety and efficacy of new treatments. This white paper reviews the regulatory, ethical, and cultural considerations surrounding the issue of placebo control in analgesia clinical trials and explores approaches to mitigating the placebo response.