Clinical Data Standards Will Optimize Clinical Trials


Clinical Data Standards

Clinical trials are marred by safety issues, budget over runs, chronic launch delays, legacy technologies and high failure rate. Some of that could change for the better from Oct, 2016; with FDA’s clinical data standards mandate.


Snail mail and fax were commonly used to exchange paper based patient medical records, until a few years ago. Thanks to the HITECH Act of 2009, we now have digital Electronic Health Records (EHR); disrupting the healthcare landscape. Real time health analytics and provider collaboration have dramatically improved patient care, satisfaction and reduced waste. Clinical trials are yet to make that transition, with many of them still using paper based health records.


Biopharma companies are required by FDA, EMA, PMDA et al., to conduct extensive Clinical trials (Phase I, II, III) to establish the safety and efficacy of new experimental drugs. Clinical trials costs $1.2 billion over 12 Yrs., with a success rate of less than 1%. Large amounts of raw clinical data (medical records) is generated across the clinical trials from disparate data sources in multiple formats creating data silos.


Without mandated global clinical data standards, legacy technologies and IT practices, result in all the disadvantages that were prevalent in pre-EHR era; but with much greater safety and financial implications. Without consolidated patient centric datasets, it is challenging to analyze for safety, efficacy and risk which are at the core of clinical trials.


FDA, with a goal of reducing costs and duration and safety concerns of clinical trials, is mandating compliance with Clinical Data Interchange Standards Consortium (CDISC) data standards beginning October, 2016. CDISC is an international non-profit organization that has established universal clinical data standards working closely with industry, regulators and other bodies. Standardized structured data sets, enables real time clinical data exchange / collaboration and better risk mitigation and overall efficiencies. Clinical trials can now leverage advances in health analytics such as pattern recognition and predictive analytics, to dramatically improve human safety.


Benefits of clinical data standards can be realized in full, only if they are globally adopted by the industry and other regulatory bodies. Japanese regulatory agency PMDA has already mandated CDISC standards. It is critical that other regulatory bodies follow suit.


Another area that could drive synergies is the transformation of EHR records into CDISC data standards. This eliminates the need for double data entry of medical records into clinical trial systems (EDC), which is time consuming, error prone and require expensive site monitoring.


In conclusion, CDISC standards have the potential to transform clinical trials resulting in more affordable new drugs within reasonable time frames.


About The Author: Sujan Thanjavuru is a thought leader and specializes in Business Transformation, Enterprise IT and Digital.


#FDA #CDISCClinicalDataStandards #NewDrugApplication #CRO #DataManagement #BigDataAnalytics #PredictiveAnalytics

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