EMA Raises Concerns with Use of Electronic Systems in Clinical Trials
[Posted on: Thursday, February 23, 2017] Auditors from the European Medicines Agency (EMA) frequently find several issues with the implementation and management of electronic systems used in clinical trials such as randomization systems, supply management, eCRF and eTMF. EMA recently released a list of common audit findings and suggested solutions related to the use of electronic systems in clinical trials. The most common reason for non-compliance was poor quality agreements between the vendors and the sponsors. The auditors found that while the vendors were proficient in information technology (IT) and data protection, they were not very familiar with GCP and quality systems requirements for clinical trials. Hence there were major deviations in the data collected using non-compliant electronic systems. Common deficiencies were lack of appropriate approval of a system before adoption, poor documentation of delegation of responsibilities across the clinical teams, uncontrolled data storage on cloud, lack of contingency plans in case of system breakdown, lack of critical quality management documents such as SOPs, training logs, validation reports and CAPA, and lack of GCP training at the vendor. The solutions suggested by EMA include common sense measures to address these deficiencies. EMA recommends training of the vendor in GCP, written approval by the sponsor before implementation of the information systems and before any changes were made by the vendor, and independent audits by sponsor to verify compliance. Similar concerns regarding electronic systems have been raised by the FDA and other regulators. The result has been a slower than expected increase in the use of electronic systems in clinical trials. About 50% of clinical trials still use paper CRF. Multiple factors have slowed implementation of eCRF including additional cost of eCRF, limited IT infrastructure at most clinical sites, inadequate training, language barriers, etc. However, with the increase in use of electronic health records (EHR), it is expected that clinical trials will increasingly use electronic systems as well. The transition from EHR to other systems is not without challenges. An article authored by multiple clinical trials experts at regulatory agencies, academia and industry, listed several concerns with integrating EHR with clinical trial information systems. The authors concluded that the immediate benefit of EHR could be in post-market data analysis to find real word evidence in support of safety and effectiveness of approved drugs but its use in prospective clinical trials is limited at best. The issues identified by EMA are most likely not limited to Europe but widespread across other regions. Developing regions in Asia, Africa and South America are known to have practical limitations in using eCRF and eTMF. Even in the US and Western Europe, critical functions such as project management and information tracking system are predominantly management manually using antiquated tools. Use of electronic systems could improve the efficiency and reduce the cost of clinical trials, we just need to make sure we do it right.
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