INSIGHTS ON CELL & GENE CLINICAL TRIALS

• Tumor-Infiltrating Lymphocytes: What, Why, And How

  As we’ve begun to understand the complexities of immune mechanisms through technology, we’ve found better ways to fight disease. Here, we focus on an important player in such targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes (TILs).

• Addressing A Critical Unmet Need: Considerations For Designing And Conducting Neonatal Clinical Trials

  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.

• Real-World Data And Real-World Evidence: What Is Their Value As A Synthetic Control Arm?

  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.

• Managing Pandemic-Related Protocol Deviations: Tips For Clinical Trial Conduct

  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.

• COVID-19 & Clinical Trials: Understanding The Long-Term Impact

  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.

• How Ramping Up Communications Helped Overcome A Next-To-Impossible Recruitment Challenge

  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.

• Direct-To-Patient Model Keeps Research Moving And Patients Safe

  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.

• Snapshot: A New Guidance Document Program From The FDA

  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.

• Understanding New FDA Guidance For Pediatric Oncology Studies

  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.

• Real World Evidence (RWE) In Regulatory Decision Making: Establishing Study Credibility And Totality Of Evidence

  This blog shares some of the learnings from the recent Duke-Margolis webinar entitled, "Bolstering RWE Study Credibility and Its Role in a Totality of Evidence Approach".