Research: Inability to Integrate Data Adds to Clinical Trials Inefficiencies

ClintexCTi’s blockchain-based all-in-one data management and analytics platform provides unique solution

New research shows that the volume and diversity of sources of data used in clinical trials is rapidly increasing at the same time that the pharmaceutical companies which run the clinical trials are having more and more difficulty aggregating and analyzing the data. This situation is putting further strain on an industry already struggling with spiraling costs and growing inefficiencies. If not addressed, the increasingly serious problem of managing data will ultimately be detrimental to patients as it will lead to more expensive treatments released on more delayed schedules.

The eClinical Landscape Study, which was conducted by the Tufts Center for the Study of Drug Development and was released in November of last year, surveyed 257 unique companies that conduct clinical trials.

According to the research, 97% of surveyed companies responded that they plan to increase and expand their use of clinical data sources. Companies already use an average of four data sources in clinical trials today but are projected to use an average of six data sources within three years. Among data sources, eInformed consent data is expected to have the biggest increase over the next three years, tripling from 31% usage to 93%. Use of smartphone and mHealth data is expected to rise by 47 percentage points, and the use of eSource data is likely to grow by 46 points, more than doubling current usage.

The main reason data sources are expanding in clinical trials is of course that with more data points it should be possible to gain a more accurate picture of the efficacy of a treatment. In addition, it is hoped that increased data sources also allow for better decision making during trials. The idea is that with more data it should be possible to save money by increasing efficiencies in the conducting of the trial.

However, the research shows that although data sources and volume are increasing, companies are actually finding it more difficult to manage the data and are less able to extrapolate correct decision making from it. In fact, nearly all (98%) clinical data management professionals report challenges with their clinical data management systems. Meanwhile clinical trial costs are spiralling out of control with the average cost to bring a treatment to market now approaching $1.5 billion.

With regards to the data management inefficiencies, the main problem according to the research is that companies are using too many data capture and analysis systems and so are unable to integrate analytics across the systems. The majority of clinical trial sponsors (77%) report that loading data into their electronic data capture (EDC) systems is a challenge, with 66% of those pointing to EDC system or integration issues as the main cause of that challenge.

The major implication here is that the companies conducting clinical trials desperately need a single integrated system.

“Having worked in the frontlines of data management in clinical trials for over two decades, I’ve seen data capture and utilisation inefficiencies time and time again. Clinical Trials require a huge amount of time and effort to manage and ensure the quality of clinical data across multiple interfaces. Even when the data is cleaned and available, the sponsor has trouble utilizing that data to its full extent because the diverse sources of data capture and input don’t smoothly integrate at the analytics level,” said Neill Barron, Director of Clinical Data Services at Clintex. “This is exactly why we designed ClintexCTi. The CTi Data Model can unite the disparate sources of clinical trials information to power advanced analytics, and help to speed up access to cheaper medicines for patients”

The ClintexCTi (Clinical Trials Intelligence) all-in-one data management and analytics solution was designed specifically to deal with the known problem of data integration. The ClintexCTi solution, with its seven connected applications, uses a permissioned consortium blockchain to enable secure and private collaboration and analysis both within and between clinical trial studies. This will allow clinical trial sponsors for the first time to analyze data across the complete range of metrics. By integrating that data, the true potential of a data analytics engine is finally unleashed.

This will at last result in the efficiencies that clinical trial sponsors have so far been unable to achieve, saving the industry billions of dollars and speeding up the development of safe and effective treatments. From a patient’s perspective, widespread implementation of a platform like ClintexCTi in clinical trials will ultimately mean lower prices for better treatments in a timelier manner.