DIA Europe 2024
DIA Europe 2024, the largest neutral conference in the European life sciences arena, will focus on sustainability, innovation and collaboration. Three new content tracks this year are:
- AI, Data Science and RWE
- Innovative therapies, precision medicine and diagnostics
- International collaboration and regional updates
It is a great platform to network and attend multi-stakeholder meetings, including regulatory authorities, patient organizations and solution providers.
Clario has two eCOA scientists presenting at DIA Europe. Valdo Arnera, M.D., Senior Director, eCOA Science & Consulting will present the results of research with ethics committees on the requirement of screenshots, and Saima Khakwani, M.Sc., MPH, Clinical Science Associate, eCOA Science will show how information provided in free text fields in clinical outcome assessments can be better utilized.
Session information:
Poster Session 1:
Title: Qualitative analysis of participant-entered free text data to inform good diary design
Date: To be confirmed
Time: To be confirmed
Abstract:
When qualitative data is collected in an ePRO diary, its design is crucial. Aim of this research was to establish how often free text was used in ePRO studies and to analyze data from free text fields entered in a diary by participants in clinical trials.
Very few eCOA studies used free text, only 2% offered a possibility for free text entry. Availability of free text entry is not often utilized by participants, only 3% free text entries were recorded in the diaries that were submitted. However, our analysis showed that responses in the free text field matched 1 of the 5 pre-defined response options. Furthermore, they showed the need for additional response options. A proportion of free text responses described symptoms or condition for which input from the study doctor could have been required to ensure participant’s safety in the trial and evaluate for any untoward medical occurrence. This qualitative analysis emphasizes the importance of good diary design.
Presenter
Saima Khakwani, M.Sc., MPH
Clinical Science Associate at Clario
Saima Khakwani is a Clinical Science Associate at Clario. Her focus in the team includes diary design best practice such as impact of use of paper and free text in eCOA, patient safety and minimizing risks for commonly implemented PROs and ClinROs and building databases. In her current role, Saima analyzes how our approach to implementing PROs and ClinROs can be tailored to decrease patient burden and increase patient engagement across various therapeutic areas and indications and build knowledge databases. She continues to work on research for improving quality of clinical trial delivery and has authored and co-authored numerous works and publications as a result.
Poster Session 2:
Title: The opportunities and challenges of CTR, one year on
Where to see it: Displayed digitally onsite and on the DIA conference app for attendees to view at any time
Abstract:
The critical part of all clinical research is that the scientific questions and objectives of the study need to be answered. The new CTR should makes this process easier by enabling one submission for authorization that covers all EU countries. Furthermore, including eDiaries and ePRO as part of the protocol submission reduces the requirements for IRB/EC submission and enables a trial to start faster. However, confusion exists around their requirements. The poster summarizes research with a number of ethics committees in the EU with the aim to provide clarity on how the new CTR is being used, in particular around the need for screenshots.
Author
Valdo Arnera, M.D.
Senior Director, eCOA Science & Consulting at Clario
A Medical Doctor by training, Valdo has over 35 years of experience in the pharmaceutical industry. Starting his career as a clinical pharmacologist in a Ciba-Geigy’s daughter company, he then founded the first European Central clinical laboratory dedicated to clinical trials, SciCor (now Labcorp Drug Development). Always passionate about how to improve the clinical trial process, Valdo joined PHT in 2000, and founded the European affiliate of PHT Corporation in January 2001. PHT was acquired by ERT in 2015 and then merged with Bioclinica to form Clario. Valdo has always taken care of the eCOA portion of Clario and is seen as one of the pioneers of the ePRO business.