GUEST COLUMNISTS

• Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations

  In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.

• Healing From A Pandemic And Building Resilience Into Future Clinical Trials

  We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

• How Trial Sites & Sponsors Can Deliver On Patient Convenience In The Age Of COVID-19

  For insights on the impact of COVID-19 on patient convenience in clinical studies, and how sites and sponsors should respond, Clinical Leader reached out to Allyson Small, chief operating officer of the Society for Clinical Research Sites (SCRS) and a nearly 20-year-veteran of the healthcare industry.

• 6 Practical Ways To Increase Diversity In Clinical Trials

  Even when a certain disease is more prevalent in a particular minority population, it can still be difficult for trial investigators to reach the right individuals. As an industry — as a group of researchers dedicating our lives to improve the health of others, regardless of their race, age, gender, or disease — how can we do better?

• 5 Common Challenges In Genetics-Based Clinical Trials — And How To Overcome Them

  Before embarking on a genetics-based clinical trial, pharmaceutical companies should fully appreciate the unique challenges genetic information presents and implement strategies to navigate potential pitfalls. Otherwise, trial progress may slow or stall, resulting in costly study delays or even trial failures.

• The Expanding Role Of Artificial Intelligence In Clinical Research

  While protocols and standards in clinical research have become increasingly complex, slowing progress and increasing costs, companies from startups to Big Pharma are identifying opportunities to apply AI to enhance trial efficiency, patient enrollment, and outcomes targeting.

• Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19

  Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

• Inside Novo Nordisk’s Patient Advisory Board Meetings

  Novo Nordisk's first DEEP (Disease Experience Expert People) Advisory Board meeting brought together leaders of patient organizations, patient advocates, and patients from five countries to participate in a dialogue with the company's Global Patient Relations team, project vice presidents, medical specialists, and trial managers.

CLINICAL TRIAL WHITE PAPERS

• Confronting The Challenges Of Rare Disease

  This paper is intended as a discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.

• Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access Programs

  Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.

• Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report

  This global research examines the drivers, barriers, and benefits of a unified clinical operating model from a CRO perspective. Findings show CROs are leading the adoption of modern clinical applications to increase efficiency, enhance collaboration, and improve trial performance.

• Returning Study Results To Research Participants

  Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants.  Read this white paper to learn about the current best practices for the content and preparation of plain language summaries, and the current guidance for how sponsors should work with Institutional Review Boards (IRBs) which have oversight of the clinical trials for which the summaries are provided.

• Special Considerations For Pediatric Trials

  Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.

• Regulatory Compliance: An Increasing Burden On Sites

  As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. But a new CenterWatch survey, sponsored by Complion, sheds some light for the first time on how, and how well, sites manage regulatory compliance.