Abstract:

Highly complex clinical trials, multiple data types coordination (i.e. electronic health records, eSource data, smart medical devices, etc.), multicentric study management and the nonstop need for continuous automatization of data management systems are just a few variables in the current multifaceted clinical trial development environment. Could you imagine how these complexities can be augmented during a pandemic?

We hear quite often that we could not predict it was coming, that the probability of a serious pandemic was not high and 2020, here we are. Would you be willing to see how many pandemics modern history has had so far? What are the chances that we will have to face another pandemic again? Should the pharma industry and clinical trial development be better prepared for the future? Let’s talk about our current challenge, the COVID-19 pandemic.

Taking into consideration the special situation that the world is facing today and the challenges the pharmaceutical industry is observing (disruption in study participants, protocol compliance, research sites accessibility, data collection continuity and processing) seems like the industry is being forced to think outside the box and come out with better solutions. There is a need to identify, manage and document impacts to clinical trials in a better way. It is time to do the deep dive on the industry weak points COVID-19 exposed and come with lessons learned:

• What proved to be the biggest issues?
• Did our initial ideas on how to deal with COVID-19 pandemic work out in practice?
• What was the cost of the mitigations and the outcome?
• Did COVID-19 catalyze any developments?
• Can we say that we are better prepared for future crisis?
• What reactions did we get from inspectors and auditors?

This session will be dedicated expose the experience gained during a pandemic which lessons learned we were able to gain. We will think together how to deal with the expected unexpected, because it will happen again.

Presenter Details:

Paulina Szczepaniak (MPharm and Operations Lead, MSD)

Paulina Szczepaniak, MPharm and Operations Lead at MSD, started her career in 2015 and progressed through multiple roles with increasing levels of responsibility and technical expertise in various Therapeutic Areas (TAs). Paulina is ensuring quality in DM processes as sub-process owner and Subject Matter Expert (SME) in clinical trial data validation as well as acting as a change agent for the adoption and implementation of new technologies and ways of working, following Industry standards and ensuring the best possible results for the end users.

Diego Gayon (Assoc. Director, Operations Lead, Merck & Co)

Diego Gayón has a degree in Industrial Engineering and a master’s in Management Control Systems, he is an Operations Lead at MSD headquarters. In his 15 years’ experience in Data Management (DM), Diego has progressed across multiple roles with increasing scope and responsibilities and across multiple TAs. Diego is currently oriented to maintain and exceed compliance and quality levels in DM processes, supports audits/inspections and continuous process/technology improvements maximizing the input of CDMs in the trial development process.

Abstract:

Following the global COVID-19 outbreak, research into the illness demanded a need for clinical trial participants on a scale never before seen in the research community. The number of participants required as well as the speed in which these had to be recruited into trials was unprecedented. Additionally, recruiting these participants during the pandemic and an ever evolving landscape presented unique challenges for both research teams and participants across the globe.
This presentation will provide an insight of what it’s been like to be on ‘the other side’ of a clinical trial during these times and what lessons could be learned; providing the perspective from a data manager who was a recent COVID-19 vaccine trial participant.

Presenter Details:

James McKenna (Lead Data Manager, ICON plc)

James started his career in clinical research over 8 years ago working on a variety of academic studies in a number of roles, where he gained a keen interest for data management. He progressed to a senior position within a sponsor organisation, developing and managing their data management department. This included taking a lead role in implementing new EDC and ePRO technologies; a project which earned the second-place ‘Innovation in Data Management’ award at ACDM’s 2020 conference.
James currently works as a Lead Data Manager in Infectious Diseases for a large CRO. His key interests include ePRO/eCOA, emerging technologies and decentralised trials.