SPEAKERS

CASE STUDY DAY 2

Incorporating Patients’ Views on Clinical Research: From Theory to Practice

Incorporation of patients’ views in the design of clinical research is evolving from a theoretical concept to a common practice across clinical research organisations. This new process requires adaptation and development of new abilities as well as incorporation of best practices. The presentation will cover practical examples and challenges from PE experience.

• Patient engagement in clinical research a new reality in clinical research
• Patient engagement requires adaptation and development of new abilities
Publication of PE activities could help to align positions and share best practices and experience

CASE STUDY DAY 1

New Clinical Trial Formats – Opportunities & Challenges

New clinical trial formats are emerging. The global COVID-19 pandemic forced the clinical trial environment to think differently and to use remote or digital technologies to ensure trial continuation. While opportunities for new clinical trial formats are obvious, there are also challenges. Decentralised clinical trials are a revolution to the trial ecosystem, that has not changed for decades.

CASE STUDY DAY 2

Understanding Patients: Needs During Drug Development – The Patient Safety Perspective

The trust of the patient into the physician is the key factor for subscribing a new drug or a therapy and afterwards adherence to treatment. Here the efficacy of the new drug is as important as the new safety profile. Sometimes Safety is even more important than Efficacy. Patient engagement for patient safety works, when it is done already during the early stages of development and insights for patient safety are generated during clinical trials. It is a drug development problem.

• Insights for patient safety
• Patient related outcomes
• Patient engagement

CASE STUDY DAY 2

Building and Implementing Data-Driven Site Selection Approaches

The COVID-19 pandemic and the focus on diversity created new challenges for organisations further reinforcing the need to be agile and adapt to change. When it comes to data-driven site selection, this means the ability to quickly integrate new data sets and layered intelligence to drive site selection. In this presentation, we will show how we adapted to incorporate new data points including site interactions, and local insights into our site selection models.

CASE STUDY DAY 1

Wearables in Clinical Trials: Friends or Foes?

As much as smartwatches, activity trackers and other 'wearables' to monitor health and wellbeing are used on a daily basis by millions around the world, the use of their connected devices in clinical trials remains limited. Let us take a close look and discuss use cases, prerequisites, risks and benefits – both from a scientific and an operational perspective.

• Patient and site perspective on wearables
• How to secure investigator oversight over collected data
• What do the data really tell us?
• Which use cases to pursue with wearables in clinical trials?