GUEST COLUMNISTS

• Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?

  The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.

• Ensuring Patient-Friendly Clinical Trials For Complex Disorders — A Small Biopharma’s Playbook

  Rezolute, a small company working in the rare pediatric disease space, is developing a new therapeutic option specifically for patients with congenital hyperinsulinism, an ultra-rare pediatric genetic disorder. Connecting and partnering with advocacy groups and physicians is paramount in the company's clinical trial execution. 

• 3 Steps To Get A Virtual Clinical Trial Up And Running

  Despite the existence of innovative technologies, they are only one piece of a complicated puzzle needed to successfully implement virtual clinical trial models. It’s critical that sponsors also consider these three key steps for achieving sustainable change in the bold, patient-centric move to virtual clinical trials.

• How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data

  Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

• 4 Practical Ways To Improve The Patient Experience In Clinical Trials

  Stakeholders have recognized the need for patients and advocates to have a seat at the table and be the central focus in enterprise approaches, commercialization, and research and development. How can we gather as much data in as few studies as possible? And in doing this, how can we acknowledge the impact that taking part in a trial has on the patients we are working to help?

• Increasing Diversity In Clinical Trials: The Critical Role Of Community Partnerships & Collaborations

  Meaningful long-term engagement, collaborations, and partnerships — rather than those based on specific trial or project needs — deepen community relationships, build trust, gain an understanding of community priorities, and make research programs more responsive to the needs, values, and perspectives of the affected populations. 

• Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow

  It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

• COVID-19’s Impact On The Clinical Trial Ancillary Supplies Industry

  With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.

CLINICAL TRIAL WHITE PAPERS

• Validation Study In Adults With Lifestyle-Related Chronic Disease

  The Philips Health Band (PHB) is a wrist-worn activity and heart rate monitoring device. This study assessed the measurement performance of the PHB in adults at risk for lifestyle-related chronic disease such as cardiovascular disease and diabetes type 2 as well as adults with existing lifestyle-related chronic disease.

• Removing Barriers To Specialty Therapies

  Gaining access to specialty medications requires navigating multiple complex pathways, including determining insurance coverage options, co-pay amounts, the patient’s total cost of therapy, prior authorizations, and appeals. Obstacles along each path can lead to increased turnaround time and drive script abandonment. Technology brings advancements for removing these barriers, but buyer beware.

• Developing Gene-Based Therapeutics

  The regulatory, operational, and commercial forces that impact gene therapy development continue to evolve dramatically – not just in the US but throughout the world. This paper explores strategic considerations for regulatory, operational, and commercial success.

• Fusing Specifications And Design For Data Collection Casebooks With Veeva Vault EDC

  Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%.

• CAR-T Cell Therapies: Safety Considerations and Toxicity Management

  Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.

• The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On U.S. Clinical Research

  As electronic research systems are increasingly relied upon to store participant data, report results, and confirm informed consent, regulatory bodies around the world are re-examining old regulations and developing new ones. Discover what it means for US research.