Past, present, and future of clinical trial data management
Clinical data management plays a pivotal role in the success of any clinical trial and during every stage of drug development. A robust clinical data management solution is critical in ensuring the data delivered to sponsors is of the highest quality, secure, reliable, and statistically sound.
In this edition of Faces of Research & Insights, we sat down with Patrick Foley, Senior Data Operations Lead, GenesisCare Clinical CRO (Contract Research Organisation), to discuss the critical role of clinical data management is clinical trials, GenesisCare’s agile approach to data management, and what the future looks like for data management in clinical research.
Q. Can you tell us about some of the key phases of data management in a clinical trial?
Clinical data managers are involved in all stages of a clinical trial, from protocol development, data collection and cleaning, through to the completion of the trial and database lock.
One of the first and most critical steps in data management for any clinical trial is building the database, designing the CRF (case report form), and ensuring the data being captured answers the primary and secondary endpoints outlined in the study protocol. In this phase of data management, we highly recommend to our clients that the database/CRFs developed conform with the CDASH (Clinical Data Acquisition Standards Harmonisation) developed by CDISC (Clinical Data Interchange Standards Consortium). CDASH establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.
Once the database has been built and the study has been activated, the Clinical Data Management team will ‘clean’ the data on an ongoing basis throughout the course of the study, looking for outlier results and discrepancies, and querying data entries that may be incorrect or inconsistent. Data cleaning is critical in ensuring that the data is reliable and consistent, and discrepancies are identified early rather than waiting for the database lock at study completion.
When a study completes enrolment, the data management team will then commence the process of effectively locking the data, a step referred to as the ‘database lock’. Once the database has been locked, the data is then extracted from the database for analysis.
Q. What excites you most about the future of data management in clinical trials? What are some of the developments you have seen in your own career?
When I first started my career in clinical data management back in the early 2000s, every step I described above was all completed on paper. Nowadays, when you are logging a query through the data cleaning process, you simply log into the CDMS (clinical data management system) and log the query, which goes directly to the site staff to address. Back in the day, when you wanted to query a data entry, you would have to write the query down on paper, the query would then be faxed to the research site each Friday, and then the research site would have to mail back the responses, and we would then manually change the database. It was a cumbersome process and the timelines for clinical trials and drug commercialisation were in most cases much longer.
Database builds have also been dramatically changed during my career – when I was starting off, we would have to manually design the database for every individual clinical trial, which used to take upwards of four months. These days you have systems such as Veeva and Viedoc, which are the platforms we utilise at GenesisCare, that essentially enable you to develop template CRFs for different types of clinical trials, that you then drag and drop when you are building a new database. You can store standardised case report library forms with different fields and entries so that you don’t manually have to create databases from scratch for every new study.
With these technological advancements the database build times have changed, and we have seen a lot of efficiency gains. At GenesisCare, on average it takes our team 6-8 weeks to build the database for a new clinical trial, which I think in large part is possible due to the technology and systems we have invested in, as well as of course the calibre of the people within our data management team.
Q. GenesisCare has a very agile approach to data management. Can you tell us about the way your team is structured and how our organisational structure helps facilitate this agile approach?
We have a very flat organisational structure within our data management team at GenesisCare’s CRO, and by that, I mean most of our data managers are senior. We have recruited data managers who have extensive experience in client management and varied clinical trials, and we have then trained them to be programmers. In the past, this organisational structure wouldn’t have been possible because you would need programmers that are able to code.
One of the main benefits of having this flat organisational structure, where your senior data managers are both the lead data manager and programmer, is that you minimise the natural communication errors that occur when you have multiple data managers working on the one project. Another key benefit is that the sponsor has a single point of contact from the data management team throughout the entire project.
Q. Technology is obviously another key enabler in providing a flexible and agile data management solution. Can you tell us about some of the technology we have invested in at GenesisCare?
Over the last decade, we have seen an evolution in CDMS systems and a suite of new integrated products, that have streamlined every phase of data management in clinical research. Some of the key platforms we have invested in at GenesisCare are Veeva and Viedoc, which are end-to-end clinical data management systems that streamline and simplify every step of data management in a study. These systems do much more than merely capture data, they can code data, integrate data, randomise data, produce reports, and even handle study drug supply. All these functionalities are integrated as well; for example, in the past for a randomised clinical trial you would have to use a third-party vendor to perform the randomisation and then merge the randomised data with the clinical data entered into the CDMS. These modern systems allow randomisation to be performed and captured all within a single platform. Last year we implemented the Veeva suite across our Global CRO, which includes the CDMS I mention above, as well as other systems, including Vault CTMS (Clinical Trial Management System) and Vault eTMF (Electronic Trial Master File).
Q. Can you tell us about your role in GenesisCare’s National Dermatology Radiation Oncology Registry (NDROR) project?
One of the first projects I worked on when I started at GenesisCare was our NDROR which was developed to collect data to evaluate specified outcomes for patients undergoing radiation therapy for skin cancer and inflammatory skin conditions. At the time I joined, NDROR had existed for about two years, and the database being utilised was relatively outdated, so we quickly identified an opportunity to streamline the data collection, cleaning and reporting. We brought the project over to a new EDC (Electronic Data Capture) platform which enabled us to have greater oversight of the data and improve the reporting to our investigators across the country. By being able to deliver timely and standardised reports to our investigators, we were able to improve the communication between our clinicians and CRO, as well as improve overall engagement in the project. We have several other registry projects currently underway within the CRO, including ADAPT-MRL, a prospective and retrospective observational registry assessing the clinical outcomes following treatment on the MR-Linac.
Q. We recently launched our IRO (Imaging Research Organisation). Can you tell us about how you have been working with the IRO to tailor our data management systems to support imaging studies?
We recently officially launched our IRO led by Dr Boon Quan Lee and Dr Danielle Meyrick, which essentially provides our customers and sponsors with access to full-service central imaging support, nuclear medicine consultancy and dosimetry.
Imaging studies are quite different to therapeutic studies, in terms of protocol design, data capture, and your endpoints, so our team have been working closely with Boon and Danielle to develop specialised systems that allow us to better collect data for imaging trials. For example, we have developed specific CRFs, systems and processes to allow ‘endpoint adjudication’ for those imaging studies that require the adjudication of study endpoints. Endpoint adjudication is the process by which an independent, blinded expert committee reviews clinical events that occur during the trial. These are assessed — adjudicated— against a set of pre-defined criteria to classify the events. As the IRO expands and conducts more and more dedicated imaging trials, these systems will be critical in ensuring we are capturing the right data to meet the imaging endpoints.
For me personally, my background is in therapeutic studies, so it has been really rewarding to expand my knowledge base and the IRO team has been great to work with.
Interested in learning more about GenesisCare’s data management team and solutions? Click here to learn more.