In this brief session, Hilde articulates the important of technology and partnership as two key drivers to enable the next level of patient centric clinical trials. In the aftermath of COVID-19, patient centricity has assumed a more important role in driving better patient outcomes and enhance organizational effectiveness.

The current model of clinical trials was already in big need for disruption and COVID-19 further changed the way we look at our trials. How does Apple innovate and disrupt its own business and industry? Does that make sense for pharma and trials? How can you and your company be part of this disruption? What is the patient's role in such a new era of digital trials? Focusing on the challenges and the view before and after COVID-19, this presentation will cover current available solutions and future outlooks, and will address the key needs from change management to capabilities to getting started.

Especially in rare diseases, patient engagement activities are becoming more and more important. This case is providing an overview of a patient engagement program implemented by Medigene AG for a phase I/II basket clinical trial in Germany. Online recruitment tools, an awareness campaign for a broad physician network, as well as a collaboration with a patient organization, are supporting patient recruitment.

In late September, the EMA released an important qualification opinion signaling its support of the use of eSource direct data capture (DDC) in clinical trials. Although the FDA had previously expressed support for clinical eSource solutions, the EMA had been cautious. The EMA’s opinion identifies many areas where eSource DDC captures source data more efficiently than traditional electronic data capture. However, despite growing evidence to support the use of eSource solutions for clinical trials, industry acceptance has been slow — mostly due to outdated process models. Join this presentation to learn about the implications behind the EMA’s qualification opinion. We’ll share an Otsuka case study that articulates the benefits of using eSource solutions and discuss how the industry can expedite the implementation of eSource.

Patient-centric data on clinical trial registries is limited by the source documents where data is extracted. TransCelerate is working on incorporating patient-centric principles in the authoring of clinical trial protocols via a free-to-download Common Protocol Template. This session will describe which trial registration fields can be extracted from the Common Protocol Template and how it can improve efficiencies in trial disclosures.

Successful implementation and use of patient-facing digital technologies (PT) in clinical trials requires collaborative effort and input from key stakeholders including sponsors, clinical research sites, patients and technology vendors. Despite this, there is often an unequal distribution of voices during the process of PT implementation. Understanding this, the TransCelerate Patient Technology initiative set out to engage all three stakeholders to better understand successful ways of working during the implementation of PT in clinical trials.

Sometimes progress doesn’t happen in a straight line. Sometimes progress zigs and zags before you reach a critical mass that results in the desired outcome. In this talk, TransCelerate would like to present some challenges that have been observed on a global scale with eConsent implementations and discuss ways to mitigate the challenges to unleash the full digital potential of eConsent.

As there are many factors that must be considered by patients when they are considering participation in a clinical trial, there are also many areas which need to be considered when developing and executing a clinical trial.  We must understand the patients’ and families’ concerns in order to assess 

Participation in clinical trials provides great value to patients, clinicians and researchers. With community oncologists treating the majority of cancer patients in the US, their role is critical in clinical trial recruitment and enrollment. Hear from clinicians and clinical trial participants about the importance of bringing trials to where the patient is being treated. Topics to be discussed: 1) Understanding the value of clinical trials offered in the community (independent physician owned) cancer setting, 2) Learn how to engage clinical trial participants to act as ambassadors in increasing enrollment in clinical trials, and 3) Gain insight from community oncology patients and clinicians about the clinical trial experience in a community setting vs. the academic settings.

Enabling research participation from home using a Decentralized Clinical Trial (DCT) model seems to be the perfect solution to improving patient accessibility and diversity. But is it really that simple? Feedback and guidance for successfully deploying DCTs to improve ethnic, racial, cultural and linguistic diversity in research will be covered.

There are various driving forces leading to the clinical research landscape evolving as the industry goes through disruption, a need for increased education, diversity in clinical trials, the impact and role of technology and even staffing changes. Additionally, Pharma is transforming its business model with biomarker and genetic data as it is playing a more significant role on drugs being approved and drugs in active R&D. The level of biomarker and genetic data collected adds more focus to rare diseases and personalized medicine; 58% of total approvals are for rare disease. There are more than 7,000 identified rare diseases, affecting a relatively small population. Companies are looking at new technologies and platforms to target, educate, engage and retain rare disease patients and diverse communities.