This article will discuss how involving your specialized CRO early in the database development phase can reduce the risk of errors and delays, as well as unexpected costs associated with avoidable database modifications.
Clinical trial sponsors can ensure optimal in-study eCRF completion and study data quality by strategically selecting specialized vendors, maximizing the value of the monitoring vendor’s contribution, and implementing cross-functional responsibilities in collaboration with the data management (DM) team.
Most full-service CROs have one department and/or therapeutic area that is the company’s flagship where significant expertise has been demonstrated. However, it should not be assumed that this level of performance translates to other service areas offered by the CRO.
Gathering a team of multiple, specialized vendors may be the most strategic approach for Sponsors to ensure overall oncology study success. Aligned with this team-building strategy, vendors that possess a collaborative approach should be valued above others during the vendor selection process.
To manage oncology studies, the requirement for cancer-specific clinical expertise is crucial, especially within the monitoring function. Your monitoring vendor holds the key to improving the quality of your database. Therefore, choosing a monitoring vendor that is specialized in oncology and that employs Clinical Research Associates (CRAs) with applied oncology expertise will go a long way in ensuring the success of your trial.
Specialized oncology CRAs are familiar with advantages and disadvantages of using different study designs, electronic systems, and data collection approaches. Their unique knowledge, in collaboration with Data Management (DM), will produce better databases (in both design and user-friendliness), as well as validation specifications that are more effective at generating cleaner data faster.
Specifically, your specialized CRO can contribute value to the development of your database in the following key areas:
1. Endpoints and Data Capture
Oncology CRAs are trained to understand the endpoints of a study, to select Sites that are capable and committed to meeting those endpoints, and to verify that all requirements of the study are met, documented, and handled per protocol, local SOPs, ICH GCP, and various governing regulations.
Coupled with their background knowledge of standardized response assessments, pathology, laboratory parameters, and safety investigations (e.g. ECG, Echo, MUGA), oncology CRAs ensure that all significant data points are collected.
In fact, frequently, CRAs are the ones identifying missing response assessment components in live databases. An oversight that could otherwise result in the study’s primary endpoints not being met.
2. Database Design
Oncology CRAs possess valuable clinical knowledge that can be used to optimize the organization of eCRFs and the order in which they appear within the Electronic Data Capture (EDC) system.
3. eCRF Completion Guidelines
Familiarity with common types of data entry errors makes experienced CRAs best suited to instruct sites on data entry conventions. They can proactively anticipate Site staff’s questions, advise on what information to include in the eCRF Completion Guidelines, and identify potential possibilities for misinterpretation.
4. Validation Specifications (also Known as Edit Checks)
Given their unique perspective and experience, oncology CRAs can suggest edit check message wording that will reduce the number of re-queries. Taking into account their suggestions for new edit checks (in anticipation of real-life data entry errors) is another way to improve the database. This will ensure that cleaner data is available faster.
5. Protocol Deviations
CRAs’ expertise is also helpful in designing simple edit checks that identify protocol deviations. Incorporating such validations into the database means better reporting capabilities and real-time trend analysis using the EDC system’s inherent features.
If given the opportunity to test the database, the knowledgeable and experienced CRAs will uncover gaps in the UAT test plan and/or validation specifications by setting up scenarios with data entry errors commonly seen on Site. Allowing CRA access to the UAT environment also provides them with the most effective training tool when instructing Sites throughout the study.
When protocols are amended, quite often there are changes that affect the database, and it is not unusual for required changes to be missed during database modifications. Given that specialized oncology CRAs are more familiar with the impact of protocol amendments to clinical procedures and the classification of protocol deviations, employing them to review the amended eCRFs and validation specifications will ensure that a single database modification will be sufficient following each major amendment.
Once a database is pushed to production, it’s the CRA who is quite often the first user to identify errors or oversights. Involving specialized, experienced CRAs early in database design for your oncology study will result in fewer database modifications, fewer delays, fewer change orders, and ultimately, a lower cost for data management overall.
Adopting a collaborative cross-functional model can maximize the value of the monitoring vendor while improving the DM deliverables. Have you asked your specialized oncology CRO for input on electronic case report forms (eCRFs) design, validation specifications design, eCRF Completion guidelines development, and user acceptance testing (UAT)?
Contributed by: Alison Foo, M.Sc., PMP, Clinical Trial Leader