Jenna Brager, PhD, RN, MS
Executive Vice President of Drug Development for MyMD Pharmaceuticals, Inc.
Data is the most important asset for a pharmaceutical or biotechnology company to produce during clinical development1. Ensuring the highest quality data in a clinical trial should be the top priority for any pharmaceutical company as it sets the stage for continued development of the product. Without it, the direction of the company cannot be confidently decided upon, thus negatively impacting the development of new treatments.
Database lock is the much-anticipated process of locking a clinical trial database to prevent further changes. This final step occurs following the conduct of a study and completion of all study-related activity. After a tremendous amount of review, query resolution and determination that the complete dataset is ready for analysis, the database is formally locked, and no additional changes can be made. This enables data collected to be unblinded and used for formal analysis or submission to a regulatory authority.
As a result, the need to develop a strong data strategy prior to study start becomes increasing important as well as ensuring it is followed over the course of the study.
A few things to consider when developing a data strategy:
1. Planning and Timing
As with many aspects of clinical data management, planning is key. To plan effectively, one must:
- Work with database teams to ensure proper data capture in relation to the protocol
- Establish solid data quality checks
- Create a comprehensive data management plan
- Clean the data by addressing issues and queries on an ongoing basis, and
- Promote engagement with the sponsor, clinical sites, and statistical teams as needed
This will support tasks are completed in the necessary sequence and completed properly. Due to the large number of individuals involved in reaching database lock, all tasks need to be specific and assigned to the appropriate group(s).2
2. Engagement of Clinical Sites (Principal Investigator and Staff)
Principal Investigator (PI) sign off is a critical step and also a potential delaying factor in getting to database lock. Oftentimes, PIs are not working in the electronic data capture (EDC) system regularly which may impact timing of sign off. PIs should be provided support to ensure efficiency in completing research subject documentation where applicable. Data issues should be addressed as they arise to avoid a backlog of queries and to prevent frustration on behalf of the clinical research sites.2
3. Review Cohorts/Groups of Data
As mentioned above, reviewing data over the course of the study helps ensure timely reconciliation of the data as a while. One way to accomplish this is to review cohorts/groups of data at time. The site monitors can be provided with sets of data to be addressed, and once done, the team can move on to the next cohort/group of data. This is an efficient way to address large amounts of data and streamlines the process at the end.2
4. Communication Across Statistical Teams
Aside from the overall study project manager, database manager, and those working to resolve queries, there are many individuals involved in database lock including:
- Statistical Team Lead
- Lead Statistical Programmer
- Biostatistics Project Team Member
- Data Team Lead
It’s important to ensure that the statistics group have been involved in the data cleaning plan as well as any data issues identified. By working jointly, the Clinical Data Management team can make sure the requirements of the statistics group are addressed.
In summary, the key areas which will ensure a smooth conclusion to the data collection process are planning and engagement. With strong attention to detail, timelines, and ongoing involvement with the key individuals, we can ensure the database is locked on time, or even ahead of schedule.
References
- Donovan, H. (2021). Why it is Critical to Have and Enforce a Data Strategy? Retrieved from: https://www.advarra.com/blog/why-it-is-critical-to-have-and-enforce-a-data-strategy
- Cytel (2016). 6 Steps to Timely Database Lock. Retrieved from: https://www.cytel.com/blog/6-steps-to-timely-database-lock
Jenna Brager, PhD, RN, MS, is the Executive Vice President of Drug Development at MyMD Pharmaceuticals. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.
Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email jbrager@mymd.com.
Recent Publications:
British Society of Immunology, Liverpool, UK, December 5-8, 2022
Pharmacology and clinical profile of MYMD-1® (isomyosamine), an oral, selective, next-generation, TNF-alpha inhibitor that crosses the blood brain barrier
Authors: Jenna Brager, Ronald Christopher, Adam Kaplin, Chris Chapman
Brager J, Chapman C, Dunn L, Kaplin A. A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects. Drug Res (Stuttg). 2022 Nov 11. doi: 10.1055/a-1962-6834. Epub ahead of print. PMID: 36368677.