GUEST COLUMNISTS

• These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D.

  Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.

• 4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma

  The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.

• 3 Key Ways To Improve Patient & Physician Education On Clinical Trials

  The success of clinical trials and the advancement of clinical research depend on the existence of a large, diverse, and motivated patient pool. Failure to educate, motivate, and engage patients to participate could have devastating effects. Here are 3 key ways to improve patient and physician education on participating in clinical trials.

• The 6 Pillars Of Effectively Managing Up In Clinical Development

  Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their 6 key lessons that they've learned along their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.

• Diversity In Clinical Trials: 10 Strategies To Increase Minority Enrollment In Oncology Trials

  Ethnicity, age, and sex can all impact safety and efficacy of any medication in people. Hence, diversity among clinical trial participants is critically important. This article shares 10 interventions to ensure participation of underserved groups to enhance diverse clinical recruitment.

• Rare Diseases: How To Leverage Social Media For Patient Analysis

  Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.

• eClinical Systems Post-COVID: Have You Realized Your Digital Transformation?

  When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?

• How Clinical Trials Execs Adapted To The Pandemic’s Digital Demands

  At the worst point during the pandemic, year-on-year enrollment of new patients globally was down 59% in April 2020. By August of 2020 (the last update published), the year-on-year impact was down only 20%. This article explores how clinical execs adapted to the pandemic's demands and offers two questions for introspection regarding patient recruitment going forward.

CLINICAL TRIAL WHITE PAPERS

• Increasing Patient Engagement With The Clinical Research As A Care Option Model

  It is estimated that as little as 3% of adults with cancer participate in clinical trials. At the same time, recent surveys have shown that up to 75% of patients say they are willing to participate in a clinical research study, indicating that many more people would take part in studies if given the opportunity. Clinical research as a care option, also known to the clinical trial industry as the CRAACO concept, offers a solution to the participation and awareness gap. This article explores the benefits of CRAACO for all stakeholders in healthcare, and outlines some of the steps necessary to turn this option into reality.

• Clinical Trial Recruitment Practices: The Evolution Of Ethical Considerations

  10/16/2019

  Recruitment practices for clinical trials have evolved significantly over the last few decades. Read this white paper to learn about the evolution of acceptable recruitment practices, and what IRB members typically look for when reviewing recruitment materials and practices.

• ChromoReport Spring 2020: Machine Learning Predictive Models

  8/27/2020

  Clinical operations staff need to have confidence in machine learning predictive models and be able to validate the accuracy of outcomes. By knowing which indicators have the most impact on these models, organizations can focus on those indicators to refine their models and learn from these insights, which can ultimately drive behavioral changes (i.e., less reliance on subjective decisions) to optimize business processes.

• Single IRB Review For Multicenter Research: A Guide For Institutions

  1/27/2021

  Single IRB review for multicenter research is now the norm in the US. Initiatives that are requiring harmonization between the FDA regulations and the Common Rule have made it clear that the federal agencies favor centralized review by a single IRB for multicenter research. Download this guide to find out about issues your institution should consider as the research community evolves into the new landscape of mandated centralized IRB review.

• Real-World Data Powers Advancements In Cancer R&D

  12/2/2020

  Innovation in the area of oncology has taken off at a historic pace. Private industry and the FDA are relying more on big data, specifically multi-source, point-of-care, real-world data (RWD) to power clinical and economic real-world evidence (RWE) outcomes. We are experiencing more powerful, streamlined ways to bring innovations and advances to patients who need them at the point of care.

• Challenges In Medication Development For Addictions

  2/12/2020

  There is a significant unmet need for medications for addictions, chronic, relapsing disorders that lead to biological and behavioral changes that can have harmful medical and psychological consequences. This paper presents an overview of the medications that have been developed for addictive disorders, the study endpoints that have been used for market approval, and the challenges companies may face when developing medications for addictive disorders.