Clinical Guest Contributors

  1. Take A Page From Amazon’s Playbook To Transform Clinical Trials

    Since my first Amazon article, readers contacted me about Amazon-like transformations in clinical research. I never expected clinical research trends to emulate Amazon’s playbook.

  2. Designing Clinical Studies To Avoid Regulatory Scrutiny

    Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.

  3. Competencies And Credentialing And Certification … Oh, My!

    In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce.

  4. Building A Stronger Community For Site-Based Research

    Leading a clinical trial at a research site as an investigator is a challenging task. Running a successful study requires the ability to manage budgets, coordinate the activities of support teams, efficiently allocate limited time and resources, and navigate the complexities of regulations and reporting obligations.

  5. Automated Site Payments: Key To Successful Engagement

    The data gathered at investigative sites during clinical trials is the backbone of the pharmaceutical and medical device development process. Without it, assessing the efficacy and safety of therapies would simply be impossible. Whether they are linked to a medical practice, part of an academic medical center (AMC), or operate independently, investigative sites are an important resource.

  6. Do Your Clinical Trials Suffer From Adoptaphobia Syndrome?

    Despite the focus on innovation at conferences, TED talks, and other forums in the last few years, as an industry we are still very slow to innovate and even slower to adopt new technologies, best practices, and methods.  This intense fear of adoption in our industry is what I affectionately call “adoptaphobia.” Adoptaphobia refers to our industry’s fear of and reluctance to adopting new initiatives, best practices, and technologies to create efficiencies and reduce redundancies.  We love to talk about issues and deliberate and discuss new methods, but we are extremely slow to commit and adopt the recommendations and methods that we agree would make everyone’s lives easier and streamline the process.

  7. What’s Behind The Gender And Ethnicity Imbalance In Clinical Trials?

    Boston Scientific deserves recognition for sponsoring the post-marketing PLATINUM Diversity study, a multicenter, open-label, single-arm, post-approval observational study focused on understudied populations: women, African-Americans, Latinos/Hispanics, American Indians, and Alaska Natives. PLATINUM Diversity enrolled 1,501 patients at 52 sites in the U.S.

  8. Key Shifts In The Latin American Central Lab Market

    Pharmaceutical companies are experiencing a significant change because of the shift in drug development toward more complex and expensive cell therapies with a focus on rare diseases.

  9. Decrypting The Utility Of Blockchain In Clinical Data Management

    According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.

  10. What Improv Comedy Can Teach Us About Communication In Clinical Trials

    Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.