GUEST COLUMNISTS

• Can DCTs Be Both Patient Centric And Financially Efficient For Sites?

  While DCTs have the potential to provide more convenience and improved access for patients, the anticipated cost savings touted for these trials have yet to materialize fully at the site level. In fact, the opposite has occurred in some instances.

• Pfizer To Provide Individual Participant Data At Scale

  Historically, clinical trial participants have rarely gained possession of their individual trial data. But now, that's about to change. Pfizer is announcing plans to return individual data to its participants beginning this year.

• Moderna Addresses Awareness Gap, Builds Community Trust To Boost CMV Trial Recruitment

  Fewer than one in four Americans are aware of the leading cause of pediatric birth defects — a common and contagious viral infection known as cytomegalovirus, (CMV). Moderna aims to overcome this awareness gap and enroll patients in CMV trials using lessons learned from its COVID-19 clinical trials.

• Navigating The Hype Of AI In Clinical Research

  When you consider the rising cost of healthcare in America, a shortage amounting to tens of thousands of physicians, and economic headwinds stirring fear across the field, we can’t afford to not use AI. We shouldn’t be asking ourselves questions of why, but rather, why not. But that begs a new question: Why haven’t we seen the impact, adoption, and value of AI more broadly across clinical research?

• Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy

  If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.

• Best Practices For Identifying And Partnering With Patient Advocacy Organizations

  When considering best practices for identifying and partnering with patient advocacy organizations (PAOs), it’s important to recognize that the process is a lengthy one that requires considerable forethought and planning. And why shouldn’t it be? In many respects, the work is similar to that performed by your colleagues in commercial and medical affairs.

• Establishing TMF Quality Goals For Greater Trial Efficiency

  Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Consultant Ken Keefer discusses the importance of creating TMF quality goals to improve overall trial performance.

• Is Being Competent And Qualified The Same Thing In The GCP World?

  When it comes to Good Clinical Practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Is "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores and explains.