Linda Tedder, Director of US Clinical Project Management, DePuy Synthes talked with the PCT audience in the final session of the day for the "Best Practices in Medical Device Trials" track. Linda brought a wealth of knowledge on clinical data collection and walked the audience through a step-by-step best practices guide based on her extensive work in the field. Below you will find the key areas to focus in on and questions to raise to ensure the best outcome when planning your very own trials...
What are you required to collect by regulatory requirements?
- FDA, clinicaltrials.gov, Competent Authorities, Notified Bodies, etc...
What do you need to collect regarding you product for safety & effectiveness/performance?
- AEs, SAEs, UADEs, USADEs, device malfunctions, product complaints
- Validated therapeutic measurement tools
What additional data are you collecting for costing benefits or because you are worried you might need it later?
- OR times, hospital stay time
- PT requirement/amount
- Return to work status
- Non-validated PROs or therapeutic specific measurement/evaluation tools
- Overall patient satisfaction
- How will the steps of the study/visits be done at the sites?
- Who will be doing what for the study?
- How will the data be collected?
- What is the evidence strategy?
Opportunities for Improvements:
- Limit free text; use drop down lists or check boxes
- Eliminate duplicate/similar questions, avoid a query cycle
- Allow sites to enter values then select measurement used
- Use dynamic forms in EDC
Data Entry & Collection:
How much data are you collecting?
- Have a plan for how the data will be used
How to avoid pitfalls?
- CCGs; having a usable CRF completion guidelines/instructions
- Site training; SC at SIV & ongoing
- Re-evaluate the database as needed/make changes (poor programming with excessive queries = frustrated sites!)
Other areas to think about:
- Linking vendors & EDC, does it make sense? (ex. core labs, IVRS/IWRS)
- Ensuring ongoing contact with sites for ensuring timely entry
How to ensure data is accurate?
- Program up useful edit checks/auto queries
- Thorough database validation through; completion of multiple test patients, interactive database review, and involvement of clinical operations
- Ongoing data cleaning
- Consider overall SDV requirements & risk-based monitoring
- Provide source worksheets
- Onsite vs. remote monitoring
- Ongoing collaboration with Data Management & CRAs/PMs
- Ongoing quality metrics
Thank you for following along with PCT 2015 & stay tuned for more updates and recaps from Partnerships in Clinical Trials.
Join the conversation on Twitter by following @PartnershipCROs and tracking all on site activity with #PCTUS