GUEST COLUMNISTS

• 4 Pitfalls To Avoid With RWE For Regulatory Submissions

  Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.

• FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

  The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion cohorts to evaluate safety, anti-tumor activity, and other properties of oncology drug products, all within a single protocol. This article shares details of the guidance as well as advantages and risks of using this trial design.

• Best Practices For Designing Patient-Centric Decentralized Clinical Trials

  Decentralized clinical trials are not universally applicable to all phases of a trial and therapeutic areas. The recommendations in this article may bring decentralized and hybrid trials to a more tangible and realistic view and, in essence, make them more executable.

• 3 Best Practices For Actionable CRO Oversight

  The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.

• How To Create An Effective Clinical Supply Visual Dashboard

  It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.

• How Can I Use Real-World Data In Clinical Trials?

  Real-world data (RWD) and real-world evidence (RWE) can be relevant and essential to bringing innovation to patients and gaining regulatory approval. This article describes the sources of real-world data, how to use real-world data to enhance a development program, and how RWD and RWE advance regulatory decision-making.

• 2021 Clinical Research Site Survey Findings: A Year In Flux

  Since its inception in 2012, the Society for Clinical Research Sites (SCRS) has conducted an annual survey of clinical research site community members to derive insights, reveal trends, and ensure the site perspective is represented. This article summarizes the 2021 survey's findings.

• 2 Emerging Investigators Share Their Journeys Into Clinical Research

  There is an urgent need to introduce more physicians to clinical research and train the next generation of investigators to reach more patients with participation opportunities. Expanding the pool to include investigators like Richard Bernstein, MD, and Thomas Moriarity, MD, is a vital step to addressing this challenge. They share their experiences in this article.