Clinical Guest Contributors

  1. These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. 7/30/2021

    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.

  2. 4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma 7/29/2021

    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. 3 Key Ways To Improve Patient & Physician Education On Clinical Trials 7/27/2021

    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.

  4. The 6 Pillars Of Effectively Managing Up In Clinical Development 7/22/2021

    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.

  5. Diversity In Clinical Trials: 10 Strategies To Increase Minority Enrollment In Oncology Trials 7/20/2021

    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.

  6. Rare Diseases: How To Leverage Social Media For Patient Analysis 7/15/2021

    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.

  7. eClinical Systems Post-COVID: Have You Realized Your Digital Transformation? 7/13/2021

    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?

  8. How Clinical Trials Execs Adapted To The Pandemic’s Digital Demands 7/6/2021

    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.

  9. 3 Clinical Trials Lessons The Pandemic Taught Us 6/29/2021

    Coming off the COVID-19 crisis, many of the creative solutions implemented because of the pandemic may actually improve previous work processes and should become part of standard practice going forward. Here are the three new approaches that you should consider for your next protocol. 

  10. 3 Easy Ways To Implement Tech & Modernize Your Clinical Trial 6/24/2021

    The life sciences industry’s digital transformation has provided the tools to overcome many of the industry’s problems and has unlocked new avenues for the role of tech in clinical trials. Going forward, clinical execs can use tech in a multitude of ways to power clinical trials.