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