Join us for a review of the journey we embraced at Pfizer in the pursuit of a pioneering vision to change the status quo in the planning, design and  inclusive recruitment of clinical trials.

While the concept of involving patients in the clinical development process has grown in focus and dedicated effort over the last few years, there is still a need for a universally accepted methodology to effectively engage with patients during protocol development and appreciate their study participant experience. Currently there are several methods to measure the patient experience in studies but none that are globally accepted by the industry. At the same time, many Sponsor companies may still lack a systematic approach to translate patient engagement into actionable insights that improve protocol design and study execution. To address this unmet need, TransCelerate BioPharma developed two toolkits, the Patient Protocol Engagement Toolkit (P-PET) and the Study Participant Feedback Questionnaire (SPFQ) Toolkit to help elicit patient feedback during protocol development and trial participation.

There is increasing focus on harnessing the power and value of data in biopharmaceutical research.  COVID-19 has punctuated the need for data-driven insight to support strategic decision making, maximum commercial value and minimal burden on patients and sites. There are numerous challenges to adoption of a data led approach. Applying an integrated approach and data driven insight across portfolios, development plans, and protocols profoundly impacts operational success, commercial interests, and patients.

As the COVID-19 pandemic disrupted life as we know it, GSK needed a way to forecast the potential disruption to operations and this required a holistic view of portfolio progress to see how studies, operations and performance may be impacted. This presentation will discuss how we were able to achieve this with the development of a COVID-19 Control Tower, and how the effort has driven the transformational clinical development initiative of a broader, enterprise wide platform for reporting and analytics, risk management and portfolio-wide decision making, known as the Clinical Control Tower.

The COVID-19 Command Platform was designed and implemented in response to the Coronavirus pandemic as it was initially beginning to impact the world, in an attempt to understand and surface information associated with potentially impacted clinical sites. Pulling information from a variety of sources, insight into the level of impact and associated country and site-level restrictions can be ascertained in near-real time. From this, more informative decisions associated with study conduct can be made. Through this example, the audience will gain insight into the response that a company had to a global incident, and how a similar approach may be implemented in the future, and how to potentially improve upon that approach. 

Current events have driven pediatric clinical research to be more flexible and efficient—to increase patient access and enhance the patient experience both during the COVID-19 pandemic and beyond. With increased regulatory support for direct-to-family (decentralized) trials, learn how to leverage technology to safely and efficiently conduct research using a current, real-life example of trial design.

How can sponsors, CROs and sites work together to develop operationally practical protocols that are both patient and site centric? Listen to the insights collected from Parexel’s Nurse Advisory Panel of more than 40 experienced research nurses and coordinators who have extensive history working with patients across multiple therapeutic areas.

This discussion will focus on how best to leverage data, technology, patient insights and innovative solutions to optimize study designs and increase operational delivery and introduce GSKs Protocol Design Lab. The session will include context and reason for change, our focus areas, the methodology and use cases and future areas of development

PRA Health Sciences needed to accelerate start-up and, together with Advarra, identified a way to activate sites twice as fast. Once study teams realized they were only leveraging a central IRB 30% of the time, that became the focus of a multi-year initiative to flip the ratio. Representatives from PRA and Advarra will outline their strategy and share results of the collaboration.