Insights on Clinical Trials

31. Developing TIL Therapies: Sample Collection And Processing 7/16/2020

    While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.

32. Tumor-Infiltrating Lymphocytes: What, Why, And How 7/1/2020

    As we explore immune mechanisms using technology, we find better ways to fight disease. Here, we focus on targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes.

33. Addressing A Critical Unmet Need: Considerations For Designing And Conducting Neonatal Clinical Trials 7/1/2020

    There is significant unmet need for approved treatments for neonatal-specific conditions. With improved understanding of the unique nuances of research in this young, vulnerable population, sponsors can increase their likelihood of developing and executing successful neonatal clinical trials.

34. Real-World Data And Real-World Evidence: What Is Their Value As A Synthetic Control Arm? 7/1/2020

    It is commonly accepted that a single-arm trial utilizing a synthetic control arm (SCA) can also be an adequate design for assessing a new treatment intervention. Single-arm trials demonstrate clinical benefit by showing the positive effects of a new therapy or treatment without the need to use placebo or standard of care as a control. Instead, RWD and RWE comparisons – leveraging a variety of sources – can serve as the comparator.

35. Managing Pandemic-Related Protocol Deviations: Tips For Clinical Trial Conduct 7/1/2020

    Conducting clinical trials of therapeutics and devices can be daunting, and COVID-19 has made this endeavor even more challenging. Here we share some tips for managing pandemic-related disruptions while collecting the information regulatory agencies will require regarding protocol deviations going forward.

36. COVID-19 & Clinical Trials: Understanding The Long-Term Impact 5/12/2020

    While most regulatory agencies have stated an intention to be flexible during these unprecedented times, it is critical that drug developers continue to monitor their risk diligently and develop contingency plans to adapt and respond to factors that affect their clinical development programs.

37. How Ramping Up Communications Helped Overcome A Next-To-Impossible Recruitment Challenge 4/21/2020

    We knew going in that it could be the perfect recruiting nightmare with extremely complex inclusion/exclusion criteria. By letting sites set their own goals and commit to them along with assigning project coordinators that stayed close to those sites the study is off to a good start.

38. Direct-To-Patient Model Keeps Research Moving And Patients Safe 4/21/2020

    In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive treatment.

39. Snapshot: A New Guidance Document Program From The FDA 4/21/2020

    In a progressive effort to mitigate these long-standing concerns and bring a level of clarity to its guidance documents, the FDA has created a pilot program called “Guidance Snapshots.” As experts, we are always debating about what the guidance is asking and how the contents are to be applied.

40. Understanding New FDA Guidance For Pediatric Oncology Studies 4/21/2020

    The Research to Accelerate Cures and Equity (RACE) for Children Act requires that any original new drug or biologics license application submitted on or after August 18, 2020, for a new active ingredient must contain reports of molecularly targeted pediatric cancer investigations if the drug is directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer. Learn more about the changes in this article.