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

  • 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.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Total Transportation Management Saves Company $10.2 Million

    A leading multinational pharmaceutical company approached Fisher Clinical Services with an extensive clinical trial pipeline and the need to achieve a comprehensive, fully-managed transportation strategy. Learn more about our outsourced transportation option that delivered tangible results.

  • The Complex Issues With Developing A Novel Human Antibody From Scratch

    Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.

  • Don’t Let Insufficient Data Undermine Your CMO & CRO Selection Processes

    Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 

  • The Digital Pill

    Although there are clear benefits with the first pill to include a digital sensor that tracks if and when it has been ingested brings, there are also questions regarding  patient privacy and choice.

  • When Other CROs Said No, We Said Yes — To The Nearly Impossible

    The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

  • Evidence Generation Strategic Partnership For Heart Failure Studies

    Read how a pharmaceutical support services company helped a large pharmaceutical company manage a portfolio of 5 heart failure studies, with over 500 investigator sites and 7,000 patients, to accompany an evidence generation program for a new product launch.

CLINICAL LEADER CONTENT COLLECTIONS

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Patient recruitment and retention continue to hamper clinical trials, causing delays in start up and forcing some studies to be cancelled altogether. Approximately 50 percent of trials have delays in recruitment, costing companies an estimated $600,000 per day. In this free collection of articles, our experts from pharma discuss the actions you can and should be taking to make trials more patient centric.

More Content Collections

FOCUS ON PATIENTS

  • 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.

  • 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.

  • 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.

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