Clinical Guest Contributors

  1. 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.

  2. 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.

  3. 5 (Fairly Simple) Statistical Analysis Plan Elements To Implement In Your Clinical Study

    My father used to say, “If you are going to do something half-assed, don’t do it at all.”

  4. Clinical Trial Deaths — Will Clearer Informed Consent Documents Be Enough?

    In October 2017, the watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, grabbed headlines when it filed a lawsuit against the FDA. The suit takes aim at informed consent regulations, seeking to ensure that potential trial participants receive sufficient information to truly evaluate the risks and benefits of participating in a drug trial.

  5. An Introduction To Contingency Tables For Clinical Study Analysis

    I would guess every researcher has come across a contingency table. Contingency tables are a type of classification table used in statistics to simultaneously summarize relationships between two categorical variables. (Let’s call them Variable X and Variable Y.) Contingency tables are also called two-way tables, cross-tabulation tables (cross-tabs), and frequency distribution tables, because statisticians like to have at least three to five names for everything.

  6. Best Practices In FDA Orphan Drug Submissions

    A common misconception in the industry is that an orphan designation is one of the easier regulatory milestones to reach. The guidance the FDA has issued on obtaining an orphan designation is relatively straightforward, perhaps so much so that it is easy to overlook some of its key elements.

  7. Analyzing The Top Clinical Trial Outsourcing Trends Of 2017

    In 2017, clinical development services did not witness any significant changes in terms of price index, input cost, and supply-demand gap in comparison to 2016. However, market competition increased, with the supply market seeing continuous mergers and acquisitions, resulting in consolidation and CROs competing for market share in terms of enhanced therapeutic area expertise, geographic reach, full-service capability, technology, and increased functional capability. 

  8. Do We Need Competency Standards For Clinical Researchers?

    For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do.

  9. Tips For Improving Communication Between Sponsors And CROs

    Clinical research is incredibly complex, and most pharma/biotech companies outsource a lot of the trial oversight responsibilities to contract research organizations (CROs).  The increasingly level of complexity and global nature of clinical research has led to poor communication within pharma and between sponsors and their CROs.

  10. 7 Breakthrough Behaviors For Clinical Research Project Managers

    Clinical project managers, your “firefighting” days can be over if you internalize and demonstrate these seven indispensable behaviors.