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On March 13, Brussels was considered the capital of Data Management, hosting the annual conference of the Association for Clinical Data Management (ACDM). Since technologies and standards continue to evolve in the ever changing landscape of clinical trials, this year the conference focused on the evolution of the profession as well as providing insight into innovations such as Electronic Health Records and Personal Digital Healthcare.
Dipak Kalra (i~HD) and Nadir Ammour (Sanofi Group) emphasized the value of (re)using Electronic Health Records(EHRs) for multiple research areas. EHRs can accelerate the conduct of clinical trials by identifying eligible patients and trial sites. In order to access this immense pool of data, it is important to create a platform that is compliant with privacy requirements and quality assurance information. The Electronic Health Records for Clinical Research (EHR4CR) project has been developing a platform since 2011 that ensures a secure connection to multiple hospital EHR systems across Europe. The platform is now being deployed commercially by Custodix, which can bring the expertise and means to support local sites upon mapping their EHR data. Eventually, only aggregated data (i.e. consolidation of data relating to multiple patients, non-traceable to a specific patient) will leave the hospital and be available for research users in the platform. With the increasing number of hospitals joining, more EHR data will be available in order to optimize clinical trials by enhancing patient recruitment and data extraction.
Image taken from presentation Dipak Kalra by i~HD, ACDM, March 2018.
The horizon for Clinical Data Managers (CDMs) consists of a fast increase in data volume, driven by new technologies (e.g. real-time data by electronic wearables) and usage of EHRs. New challenges regarding data security, unstructured data and data quality arise, making the role of CDMs even more important according to Dr. Johann Proeve (Cyntegrity). Currently, CDMs have to deal with a high volume of data, medical coding and managing of external data sources (e.g. PK data, central lab, Bio analytics data). In the future, CDMs will have to provide insight on data to other functions, such as Medical Monitors (e.g. QM reports for identification of poor performing sites) or Pharmacovigilance (e.g. provision of data from studies to ensure automated SAE reporting). Furthermore, CDMs will perform Risk Based Monitoring (RBM) to provide Risk identification and metrics on risks from past studies.
Since the ICH-E6 revision (R2), RBM has been in the spotlight. Adam Baumgart (Covance) discussed the evolving method of implementing Risk Based and Central Monitoring via a case study. Extended focus was given on risk profiling, examining in depth data and finding links (e.g. examining AEs) in order to establish a correct risk assessment. Using data visualization, it was possible to perform risk reviews using risk indicators (e.g. AEs, SAEs, query rate, protocol deviations), assess study history and compare study sites by overall risk values. In addition, incidence of AEs could be examined by medical reviewers via a visualized approach. Together, it shows that there are different approaches in monitoring to enhance the quality (i.e. critical/major investigator site audits) and efficiency (i.e. study costs) of a study.
In addition, the use of Source Data Verification (SDV) levels as part of risk profiling in RBM was discussed. Hence, a pre-study risk rating can be produced by assessing Key Risk Indicators, which can be valuable and have an impact on monitoring certain sites. Interestingly, during the discussion it was argued that SDV has shown to be of low-value. Instead, focusing on commonly observed errors commonly in CRFs, could have a higher value compared to performing a whole range SDV.
Data transparency and privacy were also discussed at the ACDM, particularly interesting given the upcoming GDPR enforcement in May. Xavier Gobert (MyData-TRUST) stated that GDPR has to be implemented and aligned to each business specificities. It is important to perform a risk analysis and review the procedures currently implemented. Continuous monitoring, control and analysis of the data are key to ensure consumer and personal data is protected. Moreover, the second step of the Policy 0070 will be enforced from October 2018 onwards. This policy is part of creating data transparency by publicizing all Clinical Trials-related information. Stéphane Chollet (Keyrus Biopharma) acknowledged that companies have to find a compromise between data utility and data protection. Analyzing data that can potentially be used to identify patients, anonymizing them and documenting the methodology is a process to implement this policy in companies.
The steady increase in data volume will have significant impact for CDMs, resulting in a substantial role for them within clinical studies. Continuous partnership with different stakeholders (e.g. pharma/biotech companies and hospitals) as well as training to stay up-to-date as a CDM are important factors to deliver clean data in clinical studies.