Clinical Guest Contributors

  1. The Time Is Now To Professionalize The Clinical Trial Workforce

    Donna was the office manager for a trucking company. Terri worked at the reception desk of a contract research organization (CRO) straight out of high school. Tom lost his job teaching history at a community college after a round of layoffs. Jessica earned her living at a local hair salon.

  2. Precise Patient Recruitment Planning – It’s All About The Patient Pathway

    At this stage in my career, I confess that I’ve lost track of the number of publications and presentations I’ve developed and delivered on the topic of patient recruitment. Many of these have focused on lessons learned from troubleshooting hundreds of trials in “rescue mode.” As I reflect on why so many recruitment campaigns or efforts fail to deliver the expected results, a common root cause issue points to the lack of understanding of the importance of, and how to create, a meaningful patient pathway. This terminology may mean different things to different individuals and organizations and may be used interchangeably with patient journeys.

  3. Initiating Multinational Clinical Trials: Major Differences Between The U.S. And EU

    There are significant differences between the U.S. and the EU with respect to the process of gaining regulatory approvals for initiating clinical trials of a new (unapproved) medication. Those differences relate to the initial regulatory submission, review, and approval process and the process for obtaining institutional review board / central ethics committee approval to initiate the clinical trial.

  4. Digital Data Flow: From A Common Protocol Template To True Digital Automation

    The biopharma industry is on the verge of moving from a highly manual document-based approach to study design, study planning, and data collection to one that can rely on currently available technology for the purposes of realizing both efficiency and improving quality.

  5. The Science Of Patient Preferences In Med Device Clinical Trial Design

    Can we optimize clinical trial design by considering patients’ urgency for new therapeutic options, as well as their willingness to accept uncertainty? A nearly two-year collaboration — between the FDA Center for Devices and Radiological Health (CDRH), Parkinson’s patients (via The Michael J. Fox Foundation Patient Council), MIT, RTI Health Solutions, and the Medical Device Innovation Consortium (MDIC) — aimed to find out.

  6. 4 Pitfalls To Avoid When Developing GCP SOPs

    This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.

  7. CRO Outsourcing — How To Optimize Your Selection Process

    This is part 2 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.

  8. How To Tell If A CRA Candidate Is Lying

    I was recently invited to speak on the subject of fraudulent candidates and fake clinical research associates (CRAs) at the Global 2018 ACRP Conference and was astonished at how many hiring managers were not aware applicant fraudulence exists. 

  9. Improve Clinical Trial Design By Getting To Know Potential Participants

    A major part of the drug development process in terms of timelines and budget goes to clinical trials. It’s no secret that a clinical trial’s success is predicated on people — people participating in the clinical trial. From developing the clinical trial design to gathering the patient outcomes, it all requires patients to be fully involved and motivated to work with the clinical trial team.

  10. 3 Major Challenges With Global Clinical Trials — And How To Overcome Them

    The disconnect between increased investment/activity and output points to continuing significant challenges in the global clinical trials market. Here we examine three of the leading issues facing the biopharmaceutical industry today.