Clinical Guest Contributors

  1. 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.

  2. 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.

  3. 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.

  4. 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. 

  5. 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.

  6. 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.

  7. 10 Key Ingredients For Small Pharma GCP Quality Systems

    Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

  8. Should You Conduct Your Medical Device Clinical Trial In Latin America?

    Bilingual U.S. board-certified physicians who have a track record of research and publications and and the fact that trial costs are significantly lower in the region, makes Latin America very attractive for U.S. life sciences companies looking to conduct cost-effective and ethical OUS clinical trials.

  9. Companion Diagnostics And The Future Of Oncology Clinical Trial Design

    In previous installments of this three-part series, our colleagues explored how the shift in the U.S. from volume- to value-based healthcare reimbursement has  1) facilitated trial sponsor willingness to integrate payer community points of view by including value-oriented endpoints and other real-world evidence-generating strategies into early clinical development activities (read Part 1), and 2) placed added pressure on sponsors to reduce price while increasing overall drug benefit delivered to patients.

  10. Lessons In Patient-Centricity From Rare Disease Clinical Trials

    Patient-centricity has been defined in various ways, but we like to think of it as simply “to identify and seize the opportunity to create value for patients — and to do so with patients whenever it’s feasible.” Pharmaceutical and biotechnology companies have begun to embrace the concept relatively recently. However, the idea — and practice — has been around for a long time in other industries.