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

• Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.

  The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

• Genetic Counselors - Helping Researchers Brace For The Silver Tsunami Of CNS Disorders

  Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.

• 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

  Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

• Clinical Trial Recruitment Practices: The Evolution Of Ethical Considerations

  Recruitment practices for clinical trials have evolved significantly over the last few decades. Read this white paper to learn about the evolution of acceptable recruitment practices, and what IRB members typically look for when reviewing recruitment materials and practices.

• Virtual Clinical Trials Best Practices

  In recent years, alongside the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials.  This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.

• Ethical Considerations In Adaptive Design Clinical Trials

  While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.