CRF Health recently held another very successful eCOA Forum, this time hosted in Amsterdam. These semi-annual meetings are a chance to get together with our clients and leading industry experts to discuss the latest developments in the field of eCOA (electronic Clinical Outcome Assessments). It is also very important for us to hear directly from clients about the real-world challenges they are facing and creative solutions they have developed to support the implementation of eCOA in clinical trials in their companies.
There were a number of presentations, workshops and hands on sessions during the two days of the Forum. However, some of the most interesting feedback was generated during four breakout sessions which sought to develop best practices in a number of important aspects of eCOA solutions, namely Study Design and Set Up; Scientific Best Practices; Training Best Practice; and Scaling eCOA for Company-Wide Use.
The Study Design and Set Up group highlighted 3 key tasks:
- Ensuring careful management of validated questionnaires being used in the study
- Developing clear protocol definitions and study design
- Initiating early vendor selection and project setup
This nicely complemented the group discussing Scientific Best Practices, where the take-home messages were all about early consideration of scientific issues relating to questionnaire choice and vendor selection.
The Training Best Practices session broke down the issues into training of the study team, site personnel and, of course, the subjects. The importance of having devices with final (or as near final as possible) software implementations was highlighted and the potential of building in scope for follow up training was also emphasized. With all training, standardizing the approach and relying less on personal skills of site staff, CRAs, etc. for example by using standard materials, training videos, etc., was also suggested as a key way of improving the quality of training delivered during studies.
Scaling eCOA for Company Wide Use was a group that generated much interest among our clients who are just starting to explore the possibilities of eCOA and are running into resistance among colleagues who are often more comfortable using paper. The suggestion for the top five things to focus on includes:
- Securing senior management’s support
- Overcoming myths and perceptions relating to eCOA
- Ensuring good risk management
- Education and communication throughout the company
- Supporting study teams
There was also a lot of stimulating discussion of the future of eCOA, with a near unanimous desire among our clients to ultimately move away from providing hardware to patients to a "bring your own device" model where patients can complete study questionnaires on their personal device. As we at CRF Health are exploring new eCOA technologies, it was great to hear the enthusiastic debate on the topic. This approach obviously raises a whole host of potential issues, some of which CRF Health hopes to discuss in more detail in future publications.
All in all it was a very successful and stimulating few days. It is important to occasionally leave the day-to-day bubble of the office and actually engage with clients in a more general setting, to understand the real issues they are having and the often novel solutions they have developed to overcome them. We hope to see some of you at our future events.
VP of Product & Service Management
About the Author
VP, Product and Service Management at CRF HealthMore Content by Rauha Tulkki-Wilke