Clinical Guest Contributors

1. 4 Questions AbbVie Asked To Create More Diverse Clinical Trials 1/17/2020

   Over the five years I have been at AbbVie, the idea of diversity and inclusivity in healthcare was especially relevant to our clinical trials in uterine fibroids. We successfully centered patients in our program by understanding their needs, concerns, and desires, which enabled us to recruit and retain women representative of the patient landscape in this disease state. How? We asked ourselves four important questions.

2. Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys? 1/15/2020

   Root cause analysis should be a chance to take a step back and try to understand why an issue occurred, and to think critically, understand the process, and determine how the issue came about. The Five Whys approach can lead us to a simple “root cause” and action, but does it enable us to really understand the issue?

3. Practical Considerations For Adaptive Designs In Clinical Trials 1/7/2020

   The life sciences industry and academic world seem to produce incredible scientific breakthroughs on a daily, if not hourly, basis these days. The pace of scientific breakthrough is mesmerizing, as a dazzling variety of technologies and studies have helped humans understand the underlying causes of disease. Whether those causes are genetic, environmental, or behavioral, it seems that we have an arsenal of tools to understand much more than ever how we can meet unmet human health needs. From the ambitious (at the time) Human Genome Project to the current application of machine learning and artificial intelligence to vast integrated data sets, it would seem that humans could be on the cusp of fundamentally altering the quality and longevity of human life.

4. Meeting Clinical Trial Data Requirements In Asian Markets 1/3/2020

   Drug sponsors looking to enter the pharmaceutical markets of China, Japan, and India will be faced with regulatory requirements specific to the design, collection, and management of clinical information that are unique for each marketplace. We’ll discuss potential strategies for dealing with these requirements, from planning to clinical studies, to successfully launch a product that’s ready for Asia.

5. Changing Your Corporate Culture To Hear The Concerns Of Patients 1/2/2020

   We can and should celebrate advances in research and medicine that fundamentally changed the lives of people in my past pulmonary practice years in New York, allowing them to hope and live with HIV infection, lung cancer, lymphangioleiomyomatosis, cystic fibrosis, and more.

6. 6 Rules For Establishing Bulletproof CRO Governance 12/23/2019

   With the increase in strategic partnerships and alliances between pharmaceutical or biotech clinical study sponsors and contract research organizations (CROs) sweeping the clinical trials industry, study sponsors often see a need to establish formal structures to help guide these relationships. This, many times, will come in the form of a CRO governance structure. And, of course, the need is not only to establish CRO governance but also to make it effective. Although each organization and relationship is unique, there are a few critical rules that can greatly increase the chance that this governance will be effective. Before exploring these rules, let’s review some foundations of CRO governance.

7. Implementing QbD In Your Clinical Trial? 4 Questions To Answer First 12/19/2019

   Quality, as it relates to clinical trials, is defined as an absence of errors that matter to decision-making. Therefore, quality by design (QbD) literally translates into an absence of errors that matter to decision-making by design. This proactive approach to quality continues to gain global and regulatory support. In fact, on May 8, 2019, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft revision of ICH E8 (R1), General Considerations for Clinical Studies.

8. What Janssen Learned From Listening To Patients In Pre-Approval Access 12/17/2019

   Patient-centricity is a much-used buzz phrase these days; however, the truth is that often the patient voice is neither heard nor heeded when creating initiatives to help them.  This can be particularly true in the pre-approval access space, where seriously ill patients who have exhausted all options are seeking access to potentially lifesaving medicines. In 2018, a first of its kind meeting was convened to hear the global voice of patients in pre-approval access (PAA).  In the EU, PAA is often known as compassionate use (CU), expanded access (EA), or managed access (MA), where the regulatory landscape is widely diverse in its requirements for seeking this form of access.

9. Pediatric Oncology Trials Under FDARA Section 504 — How To Prepare 12/12/2019

   Although the development of cancer drugs for children is riddled with challenges, the requirements in Section 504 of the FDA Reauthorization Act of 2017 (FDARA) represent a significant paradigm shift in pediatric oncology. Historically, legislative initiatives that support pediatric drug development have had much less impact in oncology than in other clinical areas.

10. Study Startup: The Case For A Sponsor Single Point Of Contact (SPoC) In Multicenter Trials 12/10/2019

    Every clinical startup requires effective management of a discrete set of activities: the production of complete and compliant regulatory documents; efficient and comprehensive contract negotiation; accurate informed consent review; and timely institutional review board (IRB) submission and approval.