ACDM Annual Conference - Summary
PHASTAR recently attended the ACDM conference in Brussels. The programme was full and interesting, with plenty of scope for questions and discussion throughout the day.
There was some time spent reminiscing and reflecting, since two of the presentations covered developments in Clinical Data Management and Coding over the last 30 years. Taking the time to think back over the changes in the scale and complexity of clinical trials over that timescale, and of course the technological and regulatory advancements in our discipline, was fascinating. We learnt that coding as we know it today originated with Dr Napke in the 1970s, organising pharmacovigilance reports in pigeonholes.
There was much talk of Electronic Health Records (EHR) and with the increasing availability of EHR, how these data can be used for clinical research. Examples of uses for de-identified patient data include protocol feasibility assessments and site and patient recruitment. Subjects’ EHR data can also potentially be used directly as eSource, instead of requiring manual re-entry into the eCRF. A lot of discussion was generated regarding the reliability and completeness of EHR data, whilst still being able to add value in the clinical research setting, with much stricter data capture regulatory requirements.
The presentations on Risk-Based Monitoring (RBM) highlighted different aspects of implementing RBM. One presenter shared his company’s experience, including considerations of the various risk assessment /review steps included in their approach, and the input of different reviewers (e.g. medical, statistical and data management) to the process, whilst the second focussed on changes in Source Data Verification due to an RBM approach – for example, different risk profiles can be assigned to trials/sites/subjects/data points, and therefore the required SDV level of the associated data can be tailored accordingly (and can be changed during the trial by triggers such as SAEs).
There was a topical discussion on General Data Protection Regulation (GDPR) implementation, which re-affirmed PHASTAR’s approach, including assessing providers, performing a gap analysis, maintaining records of data processing activities and reviewing data transfers.
Several sessions considered future enhancements the industry can look forward to, thanks to the rapid development of technology. For example, the future of Personalised Healthcare (PHC) was projected, highlighting the evolution from the ‘one drug fits all’ approach to the future of comprehensive patient profiling, enabling individualised treatment plans. A discussion of data collection via wearable devices included the question ”What is the eSource when a wearable device is used for a trial?”, and considerations of data reliability. The final presentation of the day was thought-provoking, as it considered digital initiatives such as social media, mobile data, wearables and big data and their impact on clinical data management. For example, did you know that it took 75 years for the telephone to reach 100 million users, but it took the iPhone just 4 years? And the concept of distributed studies (patient-centric rather than investigator-centric, and the patient doesn’t visit a site) is an exciting one to consider.