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September 19, 2018

Across a typical clinical trial life cycle, different stakeholders contribute to a long list of documents with specific data interdependencies – from pharmacokinetic studies, toxicology protocol (TP), toxicology report (TR), protocol synopsis (PS) to chemistry manufacturing control (CMC), informed consent document (ICD), clinical trial protocol (CTP), and clinical study report (CSR). Although each of these documents have a specific purpose, large portions of content are reused.

Reproducibility of data from clinical trials is extremely vital, and documentation at each step must be maintained with an audit trail. To ensure authenticity of clinical trial data, every document related to the trial, like CTP, ICD and CTP amendments should be timestamped. However, without any effective mechanism of timestamping documents and keeping track of the changes in these documents as they move through the lifecycle of the developing drug, both the internal and external stakeholders may often end up working on different versions of a common document. This not only leads to duplication of efforts, but also the authenticity of the document may be compromised. Manual intervention required for completing tasks as simple as mapping and validating documents may lead to linking of incorrect versions of the ICD to the protocol. Without the ability to instantly communicate content or template, it becomes even more difficult to track revisions across interdependent documents.

Establishing a Single Source of Truth

 As per Eroom’s Law, the number of new drugs approved per billion US dollars spent on R&D has halved every nine years since 1950.  For global pharmaceutical companies, this cost can be as high as USD 2.7 billion per drug, with a major portion of this cost being consumed by clinical trials.  As globalization has increased the complexity of clinical trials, the quantum of documentation has increased proportionately. This directly translates into massive increases in cost. Audit findings are increasingly pointing towards the failure of conventional quality assurance measures in ensuring effective document control. To enhance auditable document control, blockchain and distributed ledger technology (DLT) have the potential to resolve some of the challenges that medical writers/clinical researchers have been struggling to overcome.

The encryption capabilities of blockchain establish a series of immutable records as an audit trail to help identify lineage and even verify the validity of a template. Once a clear set of content management rules is defined, it can ease information distribution, and improve speed of reporting and document availability. To put it simply, it can automatically notify stakeholders of any tampering and is agile enough to be incorporated in interdependent documents without manual labor.

Achieving a Higher Degree of Order

Ultimately, it has the potential to help medical/content writers rapidly prepare submission dossier using readily available, validated content. Since changes made to a document by any node are replicated across both downstream and upstream nodes, it will help clinical researchers increase content reusability and shorten review and approval cycles. In the long run, it would help enterprises adhere to stringent compliance standards by ensuring that only the right template and the latest version of trial document are available.

Managing, tracking, and ensuring the integrity of clinical trial documents can be reimagined as a much simpler process by leveraging blockchain platforms. Such a platform can further streamline the submission to Institutional Review Board (IRB), health authorities, and more with little delay.  Although the industry may take little time to adopt such technologies because of regulatory pressure, a healthier IT budget along with buy-in from top management could help them set up real-time authoring, crowdsourcing, and data sharing platforms over the next few years.

Rita Shah is a Clinical Research professional with over 21 years of experience in academic research in the Life Sciences and Pharma domain. She is actively involved in research and development of innovative conceptual solutions leveraging automation technologies. Rita has a PhD in Organic Chemistry from Council of Scientific & Industrial Research (CSIR) and has more than a dozen research publications in peer reviewed journals. She has also worked as a Postdoctoral Fellow and Assistant Research Professor (Molecular Biology) at the Indiana University School of Medicine, USA.


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