Drug development process and COVID-19 pandemic: Flourishing era of outsourcing.

Traditional drug development is a tedious process with involvement of enormous cost and a high attrition rate. Outsourcing drug development services to contract research organizations (CROs) has become an important strategy for cost and risk reduction, capacity building, and data generation. The therapeutic and operational expertise of these CROs has allowed pharmaceutical industry to reduce in-house infrastructure as well as research capacity. Working with specialized CROs has not only increased the rate of success but also the speed of drug discovery process. Small firms with promising molecules but limited resources and large firms interested in diversifying their dimensions are utilizing the services of efficient CROs. Globally, approximately one-third of the drug development processes are now being outsourced and the data generated by the independent third party are well appreciated during regulatory submissions. In this article, we discuss the international and national trends, outsourcing services and models, key considerations while selecting CRO, and benefits and challenges of outsourcing. Further, we discuss how the technical expertise of competent CROs was utilized when traditional ways of conducting clinical trials were disrupted by the COVID-19 pandemic. Taken together, the increasing health-care demands, COVID-19 pandemic or any other such upcoming health crisis, and recent advances in advanced technologies (machine learning and artificial intelligence, etc.) are likely to fuel global CRO market in the coming years.

QUANTIFYING PROTOCOL DEVIATION EXPERIENCE BY CLINICAL PHASE

The article reports that It is widely recognized that the clinical research enterprise embraced numerous changes and adaptations during the COVID-19 pandemic to maintain patient safety, accelerate the development pathway, and ensure clinical trial continuity. Topping the list of changes is the unprecedented number of protocol deviations that have been implemented since the global lockdown.

Clinical Trial Technology: New Kids on the Block are Changing Industry Dynamics: COVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration--but progress remains measured

The article reports that Since 2017 many clinical trial vendors have developed products aimed at improving patient recruitment for clinical trials, tracking patient responses to potential therapies, or integrating all data produced in the trial technology ecosystem. The COVID-19 pandemic hastened these changes, especially related to the technologies that support decentralized clinical trials, although some observers say that many technologies now coming into view existed pre-pandemic.