Adverse event (AE) reporting is a crucial part of patient safety protection in the clinical research world. The FDA and other regulators require that clinical trial sponsors file reports on AEs, both to regulators and back to research sites. But in recent years, both the FDA and research sites have struggled under a veritable flood of AE reports that principal investigators must review to determine causality. Read More
Patient engagement is one of the hottest buzzwords in the clinical research arena. Over the past several years, sponsors, research sites and regulators have all focused more and more intensely on involving patients in clinical trials, not only as participants but as crucial partners in drug and device study development and execution. And that means research sites need to have patient engagement programs in place that will mesh well with both ongoing sponsor efforts and regulatory demands. Read More
To operate in a state of control and ensure the validity of their trials and the safety of their patients, sites must be keenly aware of and monitor vendors’ participation. Read More
Blockchain technology has begun showing promise in clinical trials as a way to control generation, management and protection of data, ensuring that data meet scientific and regulatory standards for quality and integrity and protecting patient privacy — enough promise that research organizations and sponsors are partnering up to invest in blockchain systems designed specifically for clinical research. Read More
While competence in managing the intricacies of a clinical trial is the most important quality for an investigator, how well an individual communicates and gets along with other research staff can also play a role. Research sites, CROs and study sponsors need to have criteria in place to help them select investigators who are not just well-qualified and experienced, but also easy to work with, as well as plans for managing those who may struggle with a protocol or have more difficult personalities. Read More
Although adoption of artificial intelligence (AI) has lagged in the healthcare industry, recent advancements have made the technology easier, less expensive and more convenient to implement. And clinical researchers are taking note. Read More
As the EU transitions to its long-awaited new Clinical Trial Regulation (CTR), researchers, site managers and trial coordinators in the U.S. and other countries should keep an eye on how the regulation rolls out in early 2022 and its impact on data-sharing, transparency and acceleration of trial startup, even on trials conducted in the U.S. Read More
Quality underpins every aspect of clinical research trials, from ensuring accurate data to protecting participant safety to reporting accurate results. There are so many rules, regulations and guidelines for best practices that research institutions must create an entire system of quality management measures to ensure that every trial is above reproach. Read More
Clinical trial sites should consider becoming certified in ISO 9001—Quality Management Systems to help implement a quality framework that is GCP compliant. Read More
Sites that take steps to minimize the impact of the placebo effect on trial data not only improve the overall quality of their data, they make themselves more attractive to potential sponsors. Pretrial training of both site staff and trial participants allows sites to control placebo bias from the beginning, saving sponsors time, money and the risk of skewed data. Read More
