Discussing the Challenges and Optimisation of Data Management in Clinical Research

As the volume of data increases in clinical research, organisations are facing significant challenges with data management. From data security, to storage capacity, to accessibility, companies are seeking alternative approaches to better manage clinical data. Cloud-based storage and blockchain technologies are a few of the latest innovations emerging in clinical data management (CDM). 

CDM is a crucial phase in clinical research, and refers to the processing of the vast data generated during a clinical trial. CDM is an intensive process which collects, cleans and manages subject data in compliance with regulatory requirements. 

The primary objective of CDM is the generation of high-quality, reliable and statistically sound data which can be analysed for research purposes. Efficient data management is a key part in reducing the time from drug development to marketing. 

CDM is facilitated by a dedicated team which are actively involved in all stages of the clinical trial. The Association of the British Pharmaceutical Industry (APBI)  describes the responsibilities of a data manager as the following:

• Input into the design of protocols (which define what data are to be collected and when)

• Design and approval of case report forms (on which subjects’ data are collected)

• Database design for the study (ensuring it meets requirements for data entry and reporting of the data).

Data managers are responsible for ensuring that the data is consistent, complete, and meets high quality standards. The additional roles supporting the data manager consist of the database programmer/designer, medical coder, clinical data coordinator, quality control associate and data entry associate. 

Clinical data management is a process comprising a number of stages:

• Review and finalisation of study documents 

• Database designing 

• Data collection 

• CRF tracking 

• Data entry 

• Data validation 

• Discrepancy management 

• Medical coding 

• Database locking

A wide range of data collection software and database systems support the collection and management of subject data in a clinical trial. In addition, with telemedicine becoming more prevalent in clinical research, the industry has seen an explosion of data. 

What are the main challenges facing the industry?

The increasing volume and diversity of data presents a number of challenges for integration, compatibility and interoperability, which the pharmaceutical industry must address in order to optimise drug development.

Naturally, a number of challenges are emerging, two of which are working out how to reduce the cost of storage and the management of data, and how to enable easy access for users. The cost of managing data is considerably more than storage, since organisations must keep replicates for disaster recovery and backup purposes. 

Data storage 

One of the dilemmas for pharma and clinical organisations is finding a suitable platform which has the capacity to store data securely. The maintenance cost for data storage is a particular challenge across the industry, especially in the case of on-premise data storage – the combination of operational costs, cooling mechanisms and dedicated IT resources adds up considerably. 

A significant number of rganisations are shifting towards cloud storage of clinical data. Cloud storage is described as a “cloud computing model that stores data on the Internet through a cloud computing provider who manages and operates data storage as a service”. 

Cloud storage is typically purchased from a third party vendor who owns and operates data storage capacity and delivers it via the internet in a “pay-as-you-go model”.

This platform is becoming increasingly popular in the healthcare industry for a number of reasons:

• Easy access to electronic medical records 

• Gated availability of sensitive health information 

• Integration of multiple applications, systems and third parties

• Easier collaboration between healthcare teams/providers

• Continual backup of important healthcare information 

Data governance

According to an Oracle report, data governance issues are the biggest challenge with clinical data management, in terms of meeting regulatory compliance. While it is important to enable appropriate access to data in order to improve patient outcomes, protecting the privacy and security of subjects’ data is of paramount importance. 

In a recent article, Abel Archundia, Head of Digital Transformation and IT for Bayer Pharmaceuticals discussed three potential steps organisations can take to support data security:

• Executive leadership and collaboration: recognising that cyber resilience is not solely driven by technology, but is supported by advanced training and alertness of teams. 

• Breach response: Higher level professionals should assume that a data breach will occur, and should decide how best to prepare for an incident, by checking the response capability and data backups  

• Supply chain and vendors: Seek further understanding of third party risk

Clinical organisations are also looking towards blockchain, an emerging technology which is demonstrating capabilities to support data security. Blockchain technology is a shared system for recording transactions, tracking assets and building trust in a network. 

Data is spread across a large network of databases in replica copies, rather than a single store. The benefit of this is that stored data is less vulnerable to hacking or infringement. Furthermore, the system involves verification steps which ensures the data is protected against unauthorised intervention. 

As a secure, distributed datastore, blockchain has the potential to provide the data transparency that clinical research needs. A 2019 article reinforces this point describing how such an approach could help “improve the transparency and trustworthiness of clinical trials and benefit the whole clinical research ecosystem”.

While blockchain demonstrates significant potential, it is yet to be fully implemented within clinical trials due to regulatory proceedings, according to a 2020 article.

Charlotte Di Salvo, Lead Medical Writer
PharmaFeatures