Increased regulator buy-in on the adoption of real-world data (RWD) in trials is leading to more skilled and sophisticated uses of it in trials, finally turning the hoopla around the approach into real-time reality. The potential benefits are significant. Read More
Assessment and proper reporting of adverse events (AEs) and suspected adverse drug reactions (ADRs) form the basis of risk/benefit analysis applied to investigational products. Tracking and assessing different types of AEs and determining which are related to the investigational drug under study are considered some of the most critical roles at research sites. Read More
Patient safety data collected during clinical research can vary across studies, but there is a lack of standardization of data to be reported to various regulators, sponsors and IRBs. The variation can create ambiguity for investigators working with multiple sponsors and lead to delays in assessing and reporting adverse events (AE), as well as uncertainty about the safety profiles of investigational drugs. Read More
While it would be impractical — and unnecessary — to try to conduct trials in every single recognized patient population, researchers should design trials, choose study sites and recruit patients in a way that generates data about the safety and efficacy of drugs for as much of the population as possible. This could mean conducting studies in particular places or merely increasing the numbers of patients recruited to include less-represented populations.
Bias — intentional or not — is a threat to clinical researchers and the trials they run at every stage, from recruiting participants to gathering data to managing protocols to reporting results. Because clinical research at hospitals, clinics, medical schools and other institutions is so often tied to commercial activity, such as pharmaceutical sponsors or devicemakers, these researchers must be especially aware of the pitfalls of financial conflicts of interest. Read More
COVID-related research took center stage at many clinical research institutions during 2020, helping to prevent layoffs and maintain funding for many. And while COVID-19 is likely to remain a focal point into 2021, many institutions already are making plans to revive their prepandemic research programs and even expand them. Read More
New technologies to enable decentralized, virtual and remote clinical trials are changing not only the way these trials are conducted and how researchers and participants interact, but also the roles, responsibilities and skill sets of researchers, practitioners and other personnel. Platforms, software and hardware are the engine behind the shift from face-to face encounters and on-site administration. But to make the engine run, sites will have to rethink workforce roles and responsibilities and employees will have to develop new skill sets. Read More
Regulatory and industry acceptance of the use of master protocol designs for clinical trials is growing, but a lack of data management resources and inadequate funding are hindering broader use of this approach to research. Read More