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

• What Your Clinical Study Design Reveals About Your Clinical Packaging Needs

  Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success. To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design.

• ALS Studies And Lessons Learned From COVID-19

  2/2/2021

  For ALS trial sponsors and CROs alike, the need to protect the health of study participants, the study team, on-site health care professionals, and the broader community in which the trial centers are located is of paramount importance. The question is, how to ensure this protection and conduct the trial? The answers lie in preemptive mitigation and adaptive processes that can be implemented flexibly as conditions evolve.

• How “Future-Proof” Is Your Digital Biomarker Data?

  3/5/2021

  This white paper provides a comprehensive overview of wearable sensor data processing frameworks, traditional and emerging analytic methods, and how clinical trial sponsors will maximize their investment and ensure the long-term value of their digital biomarker data by selecting a wearable technology platform that collects and provides access to raw, “future-proof” source data.

• Overcoming Clinical Trial Patient Recruitment And Retention Challenges

  5/26/2021

  Clinical trial patients face more burdens today than ever before but calculated, compassionate use of technology can ease participation for patients and their families, improving study recruitment and retention.

• Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct

  3/4/2020

  As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.

• Pharmacy Services In A Phase I Clinical Research Unit

  7/20/2020

  This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.