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

• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• 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.

• Developing A Data Strategy For Clinical Trials

  6/10/2021

  Data is the most important asset that a pharmaceutical or biotechnology company has, and the number and complexity of sources of data in clinical trials is increasing all the time; at the same time, there is increasing pressure to deliver high quality data with accelerated timelines. This white paper describes a standardized approach to developing a data strategy that can be customized to a company’s current needs and can be adjusted as those needs change.

• Practical Considerations Of A Successful RBQM Implementation

  11/22/2020

  Advances in technology, such as electronic capture and storage of study data and documentation, have accommodated the growing reliance on RBQM for clinical trials. With any new technology, there are questions about implementation and best practices.

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

  6/30/2021

  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.

• The H1N1 Study: Conducting Public Health Research During A Pandemic

  4/7/2020

  This article describes Rho’s involvement in a recent clinical trial that assessed the safety and immunogenicity of the 2009 H1N1 vaccine in adults and children (aged 12-79 years) with severe asthma.