Making connections: web-based clinical trials without the web

A web-based clinical trial, without an internet connection - so how does that work? MTI talks to Clindox, the Irish firm that came up with a solution for conducting trials in remote areas.

Obstructive airways diseases have become a major issue in India due to rapid urbanisation, the pressures of modern living and a lack of understanding of the issue among the general population.

According to the Indian government Ministry of Health, an estimated 35 million people people in India have asthma and 22 million have COPD (chronic obstructive pulmonary disease).  

The Chest Research Foundation (CRF) was initially set up in November 2002, becoming a Public Charitable Trust, in 2011. Part of its remit is to investigate respiratory diseases in India, with a focus on regional variations and causes - and to provide a clinical evaluation of drugs for the treatment of these diseases.

The respiratory trial in question involves 13,000 subjects, 250 investigators, 50 data managers and 8 different languages/dialects - an exercise of significant scale.

Mats Forsgren, CEO of Clindox, explained the company’s involvement: “We’re based in Dublin but have a development team in India and have been looking at expanding our sales into the territory. This was a perfect opportunity to showcase what our system can do, but due to some unique challenges we’ve had to do some development work too.”

Clindox believes that the clinical trial world has been slow to take up technology. Trial software systems have been around for years but typically the expense has made many smaller to mid-sized companies stick to paper-based trials. Companies like Clindox have been working to change the perception that trial systems are too slow to set-up and cost-prohibitive.

For The Chest Research Foundation, this would ordinarily have been a paper-based trial, comprising 13,000 hand-written interviews on paper. This would have involved all of the data managers manually collating the info from eight different languages in order to crunch the numbers and then make sense of it.

By working with Clindox, the CRF had an opportunity to speed up and simplify this process, but there were some challenges to overcome. The lack of internet connection in many of the regions, and the multiple language requirements were two major obstacles.

Key to this project was the development of Clindox’s CRFweb App which can be used by investigator or patient on Android or iOS. It enables data to be entered where an internet connection isn’t available. The collected data is then seamlessly synchronised later when a secure connection is available.

The group has also recently launched its ePRO (electronic patient reported outcome) module that enables the subjects to answer questionnaires at home without risk of them accessing other functionality or data. The module also facilitates a multi-language capability, which helped to address the language capability issue in India.

For this study, the Chest Research Foundation investigators visit their subjects on site/at their home and record the information on their android device using the CRFweb app in the appropriate language. When they get back to the office, the data is automatically uploaded and the data manager has the information and analysis/reporting facilities at their fingertips.

Although the CRFweb App is being utilised in this case in an environment where there is limited internet access, Clindox says it has first world benefits too. Data security is paramount in clinical trials. The app allows the investigator to opt to collect data from a subject offline without any concerns about data security, through public/private wifi etc., then later, when back in a secure network environment, the system can automatically connect and upload the data.

Clindox report that this trial is going live at the time of publication, and as such the time saving for the Chest Research Foundation will be hard to quantify until the project is complete, but the groups says “the benefits are already obvious and significant”.