Web-based clinical trials: Fast track to reach the market

The technological solutions open up more and more efficient ways of conducting clinical trial, which means accelerated advancements in ultimate patient care, says J Sairamkumar

The very mention of the word ‘trial’ brings to our mind the long and often laborious process involved in the judiciary. It is often said, ‘justice delayed is justice denied.’ This is greatly true with clinical trials conducted on pharmaceutical products. A day’s delay in the clinical trial process could potentially mean an incredible loss of more than one million dollars — probably more with the pharmaceutical behemoths.

Any new drug, variation in an existing drug, vaccine or medical equipment is subject to clinical trials to prove the safety and efficacy of its usage. The Food and Drug Administration (FDA) acts as a judge, regulating the trails and confers the final verdict. Pharmaceutical companies quickly patent any new drug formulation that is invented by them to protect their intellectual property (IP). Mere patenting doesn’t permit a pharmaceutical company to launch a drug in the market. As per FDA regulations, the new drug has to be subject to three distinct phases of trials before it can be approved for consumption.

Long trial process

The patented life of a new drug is about 20 years. The development phase including the trial process usually consumes two thirds of the patented period. It is no secret that a pharmaceutical company makes most of the profit from its products during the patented period as the price of a drug drops drastically when the patent period ends and faces open competition.

As per Gartner group, Prozac, one of the blockbusters from Eli Lilly, earned more than $2.5 billion a year until it went off-patent in mid-2001. Revenue through Prozac fell by almost 70 per cent immediately after the patent period due to competition from other generics. If Eli Lilly had shortened its R&D process by just two years, it probably would have earned an extra couple of billions.

Millions of dollars are pumped into clinical trials of hundreds of new drugs every year. Only a fraction of these drugs successfully enter the market after approval and only a couple of them turn into real blockbusters. The sooner the clinical trials conclude, the larger the cost savings that can be diverted to other R&D initiatives.

Right solutions

Having said that crunched cycle time is the key to success, the challenge is to reduce the trial duration without compromising on comprehensiveness of the trial, data security and adherence to other regulations. Web-based clinical trials are proving to be the right solution to meet this challenge. The use of web-based trial management systems, in case of large trials, have resulted in compressing the duration of clinical trials anywhere from two months to more than a year.

In a web-based clinical trial management system, data is captured through browser-based applications that can run almost any hardware supported by a trial site. The data is validated in real-time and stored in a central database. Often, a web-based trial management system supports data analytical tools that are used during the trial period and after completion.

Figure 1 presents the architecture used in a typical web based trial management system.

To appreciate the effectiveness of a web-based trial management, let’s examine the various steps involved in clinical trial and compare it with the conventional paper based system.

Figure 2 represents a typical clinical trial process.

The first step after the approval of the protocol to conduct a trial is to enroll trial sites, physicians and patients. Typically, phase 3 trial involves hundreds of trial sites covering multiple countries and ethnic groups. Web-based solution provides a greater reach and ensures faster enrolment compared to traditional channels on enrolment.

After the trial launch, in a paper-based trial, during every patient visit, data is captured by the clinical research coordinator (CRC) on paper and then re-captured thereafter on electronic media by data entry operators. This is an error-prone, time-consuming and expensive process that needs iterative corrections. Also, very often the clinical research associate (CRA) who monitors the trial progress, raises queries on the data captured. In a paper-based system the turn-around time for tracking and resolution of such issues is very high.

A typical web-based system supports, edit and checks that validate data, as it is entered. For example, if the data captured on a patient’s weight during a visit is 50 per cent more than the previous month’s visit, there is possible error in data capture. This is caught and resolved at the time of entry itself rather than through an offline, time-consuming resolution process required in a paper-based system. Also, most web-based systems provide the facility to add custom edit checks to cater to trial specific data capture. This is highly effective as every trial is unique in some ways and data capture and validation needs vary. Also a web-based system facilitates real-time audits during the trial progress.

The data consolidation, analysis and submission (to FDA) activities that happen at the end of the clinical trial is highly important. In a paper-based system this may take several months to a year, depending on the volume of data, quality of first time capture of data on paper and effectiveness of the subsequent clean up process. Whereas, in a web-based system, the data is consolidated and available for analysis and submission practically after the last patient leaves the site as part of the planned trial.

Cost-effective

In addition to the timesaving, web-based clinical trials also provide other direct cost benefits like savings on printed stationery. The cost of printing Clinical Record Forms (CRF) that are used to capture clinical data, for a single patient participating in a trial, could be as high as $100. In a paper-based trial, the CRA has to travel extensively across sites to monitor the progress, and the related expenses are usually in thousands of dollars.

In a web-based trial, travel of CRAs across various sites is avoided as the data is stored in a central location and available online. The cost saving achieved using a web-based system, in trials involving thousands of patients and hundreds of sites, is significantly high. Today’s Internet technologies match and even exceed the data security requirements of a clinical trial.

The only regulatory overhead in moving from paper-based data capture to electronic records is the need to comply with FDA’s part 11 of code of regulations-21CFR 11. The 21CFR 11 mandated requirements such as maintenance of audit trail of electronic records, access control and security are again not a significant overhead compared to the time and cost saving achieved by use of web-based systems.

Integration of web-based trial management systems with interactive voice response systems (IVRS) and electronic patient diaries (EPD) is the emerging trend in the industry. These technological solutions open up more and more efficient ways of conducting clinical trial, which means accelerated advancements in ultimate patient care. We are sure to see an increased use of web-based systems for managing clinical trails in the years to come for the obvious advantages.

The writer is senior manager, Pharmaceutical Practice Cognizant Technology Solutions