Clinical Guest Contributors

1. Extension Of The Patient: Expanding The Role Of Caregivers In Biopharma Development 2/18/2020

   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.

2. First Impressions Matter: The Importance Of CRO Introductory Meetings 2/13/2020

   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. 3 Health Tech Trends Shaping The Future Of Clinical Operations 2/11/2020

   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.

4. Are You Overvaluing Your Clinical Trial P-Values? 2/6/2020

   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?

5. Twitter Takeovers: Forging Stronger Connections With Patient Communities 2/4/2020

   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.

6. 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.

7. 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?

8. 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.

9. 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.

10. 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.