GUEST COLUMNISTS

• 4 Questions AbbVie Asked To Create More Diverse Clinical Trials

  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.

• Clinical Trial Root Cause Analysis: Can’t We Do Better Than Five Whys?

  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?

• Practical Considerations For Adaptive Designs In Clinical Trials

  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.

• Meeting Clinical Trial Data Requirements In Asian Markets

  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.

• Changing Your Corporate Culture To Hear The Concerns Of Patients

  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 Rules For Establishing Bulletproof CRO Governance

  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.

• Implementing QbD In Your Clinical Trial? 4 Questions To Answer First

  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.

• What Janssen Learned From Listening To Patients In Pre-Approval Access

  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.

CLINICAL TRIAL WHITE PAPERS

• Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments

  Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.

• Clinical Road Map To Success For Over-encapsulation

  Over-encapsulation is a widely accepted blinding mechanism used throughout the clinical supplies industry, and while the process itself may appear relatively straightforward, packaging for clinical supplies is a complex process that is strictly controlled by Good Manufacturing Practices (GMP).

• The Golden Retriever Lifetime Study: 5 Years Of Progress In Veterinary Health And Biobanking

  This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.

• Addressing Suggestibility As A Psychological Phenomenon In Clinical Trials

  How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?

• Addressing The Data Challenges Of Pharmacovigilance

  As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation – and thus value – from the data collected and processed. This paper looks at three important developments around drug safety data and their analysis and how industry is prepared for them.

• CAR-T Cell Therapies: Safety Considerations and Toxicity Management

  Along with demonstrated efficacy in hematologic malignancies, CAR-T cells have the capacity to elicit serious toxicities. Safety considerations related to CAR-T cells may impact both trial design and trial management, as the adverse events (AEs) associated with immuno-oncology agents differ from those associated with cytotoxic therapies. Learn how to make anticipating, preventing and managing toxicity a key component of clinical studies involving CAR-T cells.