GUEST COLUMNISTS

  • Extension Of The Patient: Expanding The Role Of Caregivers In Biopharma Development

    For medical product developers, the role of the caregiver is increasing as innovation advances. Caregivers may provide input on clinical trial concepts, protocol design, informed consent creation, and may also improve clinical trial recruitment and retention.

  • First Impressions Matter: The Importance Of CRO Introductory Meetings

    Pivotal first meetings with sponsor representatives or investigational sites set the precedent for future relationship development. They often serve as the introductory vehicle for key study players and require finesse to ensure success. For these reasons, all early interactions are something sponsor companies should pay close attention to.

  • 3 Health Tech Trends Shaping The Future Of Clinical Operations

    It can be overwhelming to keep up with the rapid pace of health technology advancement; in many ways, it feels like we’re just along for the ride. Let’s fast forward and take a look into three key areas of innovation that are forcing us to face and embrace a changing technological landscape in clinical research.

  • Are You Overvaluing Your Clinical Trial P-Values?

    In practice, p-values are used to weigh evidence against the risks of a hypothetical concept. So, why does the biopharma industry persist in gauging critical business decisions on the value of probabilities alone, especially as myriad examples of missed opportunities and wasted resources continue to accumulate?

  • Twitter Takeovers: Forging Stronger Connections With Patient Communities

    Learn how Tiburio Therapeutics is using Twitter takeovers, advocacy outreach, and collaboration on social media to enhance the company’s efforts to accurately capture the patient’s voice and ensure it is incorporated into future trial designs.

  • 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.

CLINICAL TRIAL WHITE PAPERS

  • Establishing Risk-Based Monitoring Within A Quality-Based System As “Best Practice” For Clinical Studies

    This report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. It found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and make rapid corrections at the site level. This type of approach is now central to ensuring the safety of patients in clinical trials, and is expected to continue to grow in importance as clinical trials becomes more numerous and complex.

  • Risk Based Quality Management (RBQM) - A Collaborative Approach To Holistic Clinical Trial Oversight

    Developing, executing, and overseeing clinical trials is a complex process. This paper shares perspectives that will assist sponsor organizations in the creation of a RBQM system in partnership with their CROs and vendors. When a shared, proactive plan is established, sponsors and CROs/vendors can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.

  • Could Adaptive Designs Be The Answer To Oncology Clinical Development Success?

    Across all therapeutic areas, clinical development faces well-documented, critical challenges that impact the pharmaceutical industry's ability to bring new medicines to patients – but in the oncology space, these issues are particularly acute. Read how adaptive trial designs can help address the challenges encountered in anti-cancer clinical development today by saving time, resources and improving the odds of success.

  • Capabilities For Clinical Studies In Contraception

    Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.

  • From Psoriasis To Behçet’s: The Evolution Of Biologics In Dermatology

    There is a clear shift in dermatology drug development towards biologics, targeted treatments, and rare skin diseases and away from topicals and symptomatic treatments. Learn more about the number of indications that are in development.

  • 3 Strategies For Integrating Flexibility Into Clinical Supply Chain Planning

    Sometimes, clinical trials do not succeed because of incomplete planning and a lack of contingencies for when circumstances change. So, how do you plan for unanticipated obstacles that may affect the clinical supply chain and, ultimately, the outcome of your trial?

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Direct-To-Representative Sample Distribution Services

    One particularly effective approach to promote prescription drug products is to have pharma sales reps ‘hand carry’ samples to the health care practitioners within their territories.

  • Six Trends Shaping Tomorrow's Clinical Trials

    Due to the continuous growth in drug development costs, there has never been a greater need for new and innovative ways to support the clinical trial supply chain. Explore key trends that are pushing the innovation envelope.

  • Seven Strategies To Avoid Delays In Clinical Supply

    Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor. Delivery delays or under-projection of needed quantities could have a negative impact on timelines, budgets, and patients relying on new treatment options for unmet needs. In this article, learn seven strategies to help you avoid clinical supply delays.

  • 2018 vs. 2010 FDA Draft Guidance For Industry On Adaptive Designs For Clinical Trials Of Drugs and Biologics

    In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).

  • Regulatory Inspection SOP Checklist: How to Prepare for an Inspection

    A best practice for inspection preparation is a standard operating procedure (SOP) that codifies the roles, procedures, and training your organization will enact in preparation for an announced inspection.

  • SENA Incorporates Participant Payment Automation To Improve Clinical Trial Operations

    Southeastern Nephrology Associates (SENA) have been providing high quality nephrology, kidney dialysis, kidney transplant and hypertension care for patients since 1975.

CLINICAL LEADER CONTENT COLLECTIONS

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 In this eBook, we present the stories of four companies attempting to overcome these challenges and bring effective therapies to patients in need. Dr. Brian Schwartz, CMO for ArQule, discusses the challenges of an ultra-rare disease trial; Dr. Pushkal Garg, Chief Medical Officer at Alnylam Pharmaceuticals, discusses new approaches to patient-centric drug development; Mallory Factor, chairman of IntraBio discusses what government can do to help promote orphan disease research, and a panel of experts discuss what progress is being made to bring treatments to rare disease patients.

More Content Collections

FOCUS ON PATIENTS

  • Extension Of The Patient: Expanding The Role Of Caregivers In Biopharma Development

    For medical product developers, the role of the caregiver is increasing as innovation advances. Caregivers may provide input on clinical trial concepts, protocol design, informed consent creation, and may also improve clinical trial recruitment and retention.

  • Twitter Takeovers: Forging Stronger Connections With Patient Communities

    Learn how Tiburio Therapeutics is using Twitter takeovers, advocacy outreach, and collaboration on social media to enhance the company’s efforts to accurately capture the patient’s voice and ensure it is incorporated into future trial designs.

  • 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.

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