Clinical Guest Contributors

  1. 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.

  2. 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.

  3. 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. 

  4. 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.

  5. 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.

  6. 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.

  7. Wearable Derived Data In Clinical Trials: The Biggest Barriers Are Crumbling

    Previous articles on Clinical Leader have discussed the potential benefits of wearable devices for remote patient monitoring in clinical trials. In addition to possible increases in trial efficiency and reduction of costs, “wearables” have the potential to collect data better reflecting patient functioning and response in the real-world setting.  According to the Clinical Trials Transformation Initiative’s Mobile Clinical Trials (MCT) Program, mobile devices, including wearables, offer the opportunity to collect more complete and informative data than ever before. Mobile devices may also reduce the patient burden in clinical trials, thus enhancing the patient experience.  Companies are exploring the use of wearable devices in the post-marketing setting as well, as a component of patient care. 

  8. The Role Of Modeling & Simulation In Clinical Trials

    Modeling and simulation (M&S) in the drug development process is an industry-proven scientific approach used to inform crucial drug development decisions such as dosing, drug-drug interaction (DDI), and other critical safety and efficacy questions. The FDA has shown a strong commitment to utilizing M&S in the drug development process.

  9. The Making Of A Patient Advocate For The Clinical Trials Enterprise

    As a sea change has occurred over the last several years embracing patients as key stakeholders critical to clinical trial success, patient advocates who are knowledgeable about research have been increasingly sought after. Questions have been lightheartedly raised about how we “clone” the patient stakeholders who’ve made impact in the clinical trials enterprise (CTE) to date or create educational programs for the next generation of patients who express interest in getting involved.

  10. CRS Lawsuit: Does FDA Guidance Require More Clarity?

    The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.