Clinical Leader E-Books

1. Psychedelics In Clinical Research 9/18/2024

   This eBook is a curated collection of some of Clinical Leader’s most recent articles focused on the challenges, opportunities, and real-world examples related to psychedelic clinical research. You’ll find insightful and valuable content on everything from innovative trial designs to ethical considerations to regulatory reviews.

2. Realizing The Value Of RWD 5/22/2024

   Able to add data richness and accuracy to clinical trial data and results, real-world data (RWD) has the potential to improve clinical trial design, influence regulatory approval, and, overall, positively affect drug development.

3. Perspectives On DEI You Haven't Heard Before 3/11/2024

   The clinical trials industry teems with experts who have diversity, equity, and inclusion (DEI) know-how and on-the-ground experience. They offer not platitudes but real ways to design and implement clinical trials. Learn about the barriers to clinical trial participation, as well as how to develop a diversity action plan (DAP) and achieve success in improving diversity.

4. Clinical Data Collection: Best Practices And Latest Trends 8/9/2023

   Collecting clinical trial data can prove to be a demanding endeavor, but it is arguably the most crucial part of the study process. And to do it well, clinical data managers must master every aspect of the data collection and management journey, including determining what type of data to collect, deciding how to collect it, and determining how to store and analyze it.

5. Regulatory Readiness: Best Practices For Clinical Trial Compliance 5/30/2023

   Let’s face it: Clinical trials and, to some extent, their sponsoring companies can live and die by decisions made by the FDA. And while regulatory matters simultaneously motivate and strike fear in the folks working in regulatory and compliance roles, clinical research professionals across functional areas are best served when they too stay abreast of the FDA’s every move.

6. Strengthening The Sponsor-Site Relationship In Clinical Trials 4/18/2023

   The past several years, due in part to the impacts of the COVID-19 pandemic, have been particularly challenging to clinical sites. From adopting new operating models and myriad technologies emanating from decentralized clinical trials (DCTs) to mitigating the financial impacts of inflation to managing ever-increasing responsibilities amid staffing shortages, sites have been tasked at nearly every turn.

7. Overcome The Challenge Of CRO Selection 4/20/2022

   When I speak to clinical executives from large pharma companies, they always seem to be interested in the trending topics of the day. Those topics might include AI and machine learning, blockchain, real-world evidence, adaptive trials, and more. When I speak to executives from small pharma and biotech companies, the conversations are very different. Their interests lie in what you might call the basics of clinical trials. Those basics include selecting and overseeing sites, CRO oversight, and patient recruitment. One of the greatest challenges for those companies always seems to be CRO selection. The articles in this e-book all relate to the challenge of CRO selection. I hope you enjoy them and learn from the insights contained in them. I wish you the best of luck in selecting your next outsourcing partner.

8. Hybrid & Decentralized Trials 11/24/2021

   Hybrid and decentralized approaches have the potential to revolutionize clinical trials. These new technologies have existed for years, but the COVID-19 pandemic in 2020 hastened their adoption by drug developers.

9. Real-World Evidence 11/10/2021

   The data gathered by researchers during a clinical trial might be sufficient to garner a regulatory approval, but it does not provide sponsor companies with a holistic view of how the drug will perform when made available to the general public. The small number of patients participating in trials, coupled with the lack of diversity present in those populations, makes it difficult to understand the full effect a treatment might have in patients.

10. Patient Diversity in Clinical Trials: What Progress Has Been Made? 8/11/2021

    In November 2020, the FDA released guidance on enhancing diversity in clinical trials. The guidance, first issued as a draft in 2019, provides the agency’s thinking on steps to broaden eligibility criteria in clinical trials. Although patient diversity is a concern for pharma and biotech companies, the solutions to recruiting more diverse patient populations are not easy to come by. It seems clear, however, that recruiting minority patients will involve education, building trust, a different type of outreach, and engaging with new site partners.