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
The roles of CRAs and CRCs continue to evolve and are likely to become more managerial and professional with less of a focus on lower-level tasks as trials emerge from the pandemic. 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
Spurred by the shift to decentralization, the clinical trials workforce needs new roles and skill sets to master a rapidly changing environment. Read More
Using risk-based quality management (RBQM) can help sites and sponsors meet regulatory expectations while also making them more agile and better able to navigate unexpected challenges, such as the COVID-19 pandemic. Read More
Take it from the agency that conducts inspections of pharmaceutical and research and development sites: If there’s one key to avoiding administrative action, disqualification and other penalties, and legal action, it’s documentation. Read More
The future of trials depends on a focus on patient-centricity as the industry moves past rapid adoption of novel trial designs and technology that aids in decentralization during the COVID-19 pandemic, industry experts named to the PharmaVOICE 100 for 2020 forecast last week. Read More