Importance Of It In Clinical Trials

By Author: Ragalahari
Total Articles: 4
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The sensitivity of the processes implies that clinical trials are long drawn processes, often lasting more than seven years from designing and planning of protocols to the final report. Every additional month or year of delay implies millions of dollars in costs and lost revenues for pharmaceutical companies; not to mention the high risk of ensuring the sanctity of the data from clinical trials. A streamlined and speedy process for clinical trials impacts positively the economics of companies, and often times dramatically.
Pharmaceutical companies, have, therefore always been on the lookout to boost the productivity of clinical trials. Some of these initiatives have included adoption of new scientific approaches to refine design of trials, globalization of trials for broader pools of patients and researchers and technological capabilities. Despite all these innovative approaches, end-to-end improvements in trial performances have been hard to achieve. Primary among the reasons towards this have been:

Lack of proper coordination between trials across the organization resulting in loss of transparency
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... Inability to leverage historical work, specially pertaining to design of trials; instead of re-using and learning from experience, teams continue to re-create protocol designs from scratch each time, resulting in a lot of wasted time and effort
Unreliability of EDC Study SETUP systems has meant numerous hours spent verifying and matching electronic data against actual physical data
Incomplete performance measurement programs that fail to look at programs holistically and focus on specific parts only

As the search for productivity continues, organizations have increasingly found that re-doing IT systems and increasing their effective usage in clinical trial programs can address a lot of the above concerns and challenges.

How IT helped clinical trial efforts

Leading pharmaceutical companies that have undertaken programs to re-align their IT systems have reported as much as 10% reduction in trial durations. Companies have focused on improving speed, quality and costs through a combination of activities: focusing on the right and accurate data, managing workflows and data transparency across the activity chain.
With costs skyrocketing, companies are turning to computerized systems and IT solutions to increase productivity and maximize the efficiency of clinical trials. The adoption of such solutions will be integral in enhancing and transforming the data collection and management aspects of a trial.


Another key activity that has immensely benefited from this wave of applying new technology has been in information and process design. Critical ways where technology can and has begun to play a role include:

Integrated planning of clinical trials across the organization enabling the best leverage of resources and their allocation as needed to teams
Use of modular design, leveraging past work to create electronic case-report forms
Use of electronic data capture systems at the origin point of data, i.e. by physicians
Integrated data system that gives management an end-to-end view of trials, enabling better and quicker decision making

An IT focus on the following areas in clinical trials can deliver immense value to pharmaceutical companies and other stakeholders and build a more efficient value chain:
Clinical data management: this could include databases of investigators and their preferences to support design of electronic forms, standard interface to integrate third party systems and automated data checks to maintain data integrity acting as a bar code for the clinical trials/ subjects