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.
FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
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.
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.
Not a day goes by when we don’t learn of yet another application for mobile phones in healthcare. The list includes using mobile phones to diagnose and manage health-related conditions, to monitor subjects participating in clinical trials, and to conduct remote consultations with physicians and other caregivers.
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.
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.
The new year is just around the corner, signaling a fresh start and new beginning. Janus, the Roman god of new beginnings and namesake of the month of January, likely inspired our familiar tradition of reflection and resolution this time of year. Janus had two faces, which allowed him to look backward to the past and forward to the future.
Being exposed to different CMOs during a well-structured bidding process will allow small and virtual pharma companies to assess what type of CMO would be the best fit for their business model.
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.