How big data is transforming the clinical trials landscape

Currently, Randomized Controlled Trial (RCT) is the gold standard of clinical research, but with caveats. Translating biological efficacy into clinical efficacy is a major hurdle. Since RCTs are conducted in strictly monitored environments and even stricter guidelines, their implementation in real-world healthcare situations falls short of desired outcomes. This is true especially for the underserved healthcare ecosystems where lack of infrastructure, facilities, technology, imbalance between trained adequate manpower and patient population, and other factors prevent research outcomes to bear fruit in real-world treatment regimes.

A ray of hope to arrest this inadequacy is Big-Data Clinical Trial or BCT. With its intrinsic advantage of data-guided interventional models, clinicians are now better-equipped to derive accurate and efficient treatments using BCT.

How has big data revolutionized clinical research?

Since data feeds from trial sites are received in real time and their inflow is continuous, researchers are able to construct precise predictive analytics models based on the latest information gathered around vital trial factors such as drug tolerability, drug exposure levels, drug immunity, tolerability, patient safety, treatment outcomes, and other matrixes. The combination of up-to-the-minute data updates, their unquestionable reliability, and their “anytime” accessibility creates an agile research environment in which continuous data modeling as well as continuous data “editing” is made possible, due to which rehashing of analytics is possible on the go as trials progress. Eventually, as trials conclude, such humongous data analyzed on a daily basis creates robust, reliable, and resilient BCT models.

Automation further helps to improve accuracy and effectiveness of analytics, since the human error factor is discounted in BCTs.

Thus, traditional data-dependent clinical trials are rapidly transforming into data-driven activities, thanks mainly to the BCT models. As Associate Director & Head, Emerging Analytics and Advanced Visualizations, Janssen Pharmaceuticals, articulates, “This (BCT) has culminated in sponsors of trials having the unique opportunity to leverage big data and advanced analytics to optimize and improve clinical trials operations at a time when advanced analytics is coming of age.”

The 6 V’s of Big Data

The business side of BCT

How does the BCT ecosystem enable businesses to improve their top-lines and bottom-lines?

BCT design and implementation often incorporate other information provided by sponsoring clients, such as biomarkers, claims data, data from wearables and medical devices used on patient population, their medical imaging and electronic records, and the like. This combination of multiple factors facilitates superior trial outcomes, the end-result of which is safer drugs with better efficacy. Good products mean good profits.
BCT programs are cost-effective. Extraction, extrapolation, synthesis, analytics, and reporting of data through manual processes is often costlier than the automated versions.
BCT models ease the pain of patient recruitment and reduce their dropout rates, hence improving results and enabling companies to produce drugs with better efficacy on a wider section of real-world patients.
BCT not only streamlines the entire trial process but also reduces trial time, thus eliminating delays.
These trials reduce the go-to market time of end-products.
And of course, ready-to-serve big data analytics are availed faster with BCT.

Additional benefits of big data in clinical trials

Aside from research and trials, big data has also helped in improving post-trial value chains, and made it easier for clinicians to treat patients. Be it medical infrastructure, healthcare professionals and frontline workers, logistics, supply chain, delivery, or availability, big data has produced positive results across the healthcare pipeline.

How effective is BCT in healthcare decision-making? We get an inkling from the fact that COVAX succeeded in delivering 1 billion vaccines to 144 participating countries by January 2022, thus making the vaccination drive equitable and inclusive with the help of big data.

Human longevity has increased from 66.8 years in 2000 to 73.4 in 2019. However, healthy life expectancy remains at 63.7 years. As we live longer, we are predicted to fall sick often and face many new health threats during our lifespan. Amidst this classic paradox, big data and BCT have emerged as the sunrise factors in clinical trials and healthcare domains.

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From RCT to BCT: How Big Data is Transforming the Clinical Trials Landscape

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