Featured Clinical Leader Editorial

  1. Designing A Phase 3 Clinical Trial In Rare Dermatology: Lessons Learned 7/15/2022

    Rare dermatologic disease R&D is growing at a much faster rate than other fields in dermatology. Even before the data readout from our Phase 2b study, we began formulating several possible Phase 3 trial designs and asked scientific, operational, and regulatory questions. Here are our lessons learned.

  2. Decentralized Clinical Trials: Key Considerations For Sites & PIs 6/21/2022

    As we work to harness the benefits of hybrid and DCTs, sites and investigators must have processes that allow for the acceptance of DCTs and successful implementation. As these policies are under development, the vital viewpoints of sites and PIs are largely overlooked. This article shares these vital viewpoints of sites and PIs.

  3. How To Navigate Drug Repurposing And Bridging Studies 6/17/2022

    Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials. 

  4. Digitally Enabled Clinical Trials: A Practical Guide 12/2/2021

    Undoubtedly, digital trials will stay as the world coexists with the pandemic, so it is essential for both sponsors and sites to be early adopters. This article will examine the benefits and challenges of digital clinical trials and identify key considerations for sponsors and sites as the world continues to navigate the new normal.

  5. Digital Vs. Decentralized Trials: What's The Difference & How Do I Meet Implementation Challenges? 11/18/2021

    Digital clinical trials, which have gained momentum since the onset of the pandemic, have the potential to address many of the inefficiencies of traditional trials. This article defines digital clinical trials and how they differ from decentralized clinical trials, as well as how to meet implementation challenges.

  6. Is A Decentralized Clinical Trial Right For Your Trial? & 5 Tips For Success 11/11/2021

    Pharmaceutical companies have achieved considerable success in decentralizing clinical trials and shown that this model can offer significant benefits — both during the pandemic and afterward. While some elements of decentralization can be applied across all trial types, this article covers several specific trial characteristics that are particularly suited to remote studies, as well as tips to maximize success.

  7. How Biopharmas And CROs Can Create Value In Decentralized Global Trials 11/2/2021

    The need for biopharma execs to effectively engage CROs in decentralized clinical trials will only increase in the years to come. This article examines the results of a recent Ernst & Young (EY) study and also offers some recommendations for sponsors and CROs to be more effective with decentralized trials.

  8. Decentralized Clinical Trials: What Are The Opportunities For Data & Cost Savings? 10/19/2021

    Among our industry, sentiment remains positive that decentralized clinical trial models will improve patient centricity and reduce time to market for critical treatments, among other benefits. However, let's take a closer look at this transition to a more decentralized method, focusing in on the opportunities for data and cost savings.

  9. Decentralized Clinical Trials: Does Your Strategy Include These Facets? 9/30/2021

    Decentralized clinical trials have increased in response to the COVID-19 pandemic, yet this may be due to a convergence of two factors already in play: our reliance on the use of digital health technologies and a move by the FDA and industry toward patient-focused, real-world clinical trials that leverage the technological advances already available.

  10. 3 Steps To Getting Your First Decentralized Trial Greenlit & Executed 8/17/2021

    Decentralized trials are complex, yes, but they are just a different kind of complex. Halloran Consulting unpacks the top three strategies to consider before you begin your decentralized trial design and champion your vision to executives.