Clinical trials still offer the most effective way of testing the safety and efficacy of new drug treatments, and as more drugs are brought through development each year, the number of trials conducted grows. Gilbert Hunter at Formedix, explores how the use of next-generation, all-in-one, cloud-based clinical metadata repositories (CMDRs) can provide the automation, standardisation and control needed to optimise clinical trials.
Extract:
Could Standardised Metadata be the Key to Optimising and Expediting Clinical Trials?
Clinical trials still offer the most effective way of testing the safety and efficacy of new drug treatments, and as more drugs are brought through development each year, the number of trials conducted grows (see figure 1). Indeed, at the time of writing, there are currently 390,644 registered studies live in 291 countries. Although clinical studies are tried and tested, they are by no means static; trials are constantly evolving in response to patient needs and changing technologies, incorporating more complex and adaptive designs, and allowing for more detailed data collection. Together with the need to comply with more stringent regulations and frequently updated standards, clinical trial managers are under increasing pressure to deliver optimised and streamlined trials that deliver safe and efficacious drugs faster and more cost-effectively.
Despite these pressures, many organisations still rely on manual processes, disparate systems and fragmented workflows to manage the metadata that supports and powers clinical trial design, data collection and regulatory submission. These traditional and out-of-date models can cause errors, inconsistencies and delays. Costs can soon escalate as trial managers struggle to find, use and manage metadata and, the issues don’t stop there, as when it comes to preparing metadata for regulatory submission, a longwinded programme of rework is often needed.
This article explores how the use of next-generation, all-in-one, cloud-based clinical metadata repositories (CMDRs) can provide the automation, standardisation and control needed to optimise clinical trials.
Metadata: The Underlying Framework for Successful Trial Design and Execution
Metadata underpins every clinical trial. It is the consistent framework that enables stakeholders to access, monitor, log and track data, and it is critical to every stage of a trial, from design to regulatory submission. Effectively managing metadata is critical to delivering fast, efficient and cost-effective trials that contain robust and reliable data. But to optimise the use of metadata, team members need to have access to the correct versions, in a readable format, when they need it.
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