Pharmaceutical companies could save anything from US$10-US$15 million a year on paper and postage alone by implementing eClinical solutions, a new report says. But it also warns that adoption of these solutions will remain slow until all stakeholders in the clinical trial process are ready to “make the necessary mental and cultural switch”.

Of the US$1 billion spent on bringing a new drug to market, US$500-US$700 million goes on clinical studies, notes the Datamonitor report, In Pursuit of the Paperless Clinical Trial: A Look at EDC and CTMS.

Life sciences companies worldwide, which already spend between US$12 million and US$17 million per year on mailings and copies of paper case report forms, are looking to eClinical solutions such as electronic data capture (EDC) and clinical trial management systems (CTMS) in an effort to improve efficiency and cut costs during this most expensive phase of drug development.

As the report points out, a number of pharmaceutical companies and contract research organisations (CROs) already have strategies in place to use EDC for 100% of their clinical trials by 2010. “Although there are several roadblocks ahead, Datamonitor believes the adoption of EDC will be rapid through 2012, at which point it will plateau out,” the market analysts comment. “The industry will also see an increase in the adoption of CTMS as management becomes a greater issue due to the globalisation of clinical trials.”

Adaptive benefit

One benefit of these trends will be adaptive clinical trials – another strategy to accelerate drug development, under which sponsors can alter trial designs or cancel the trial outright on the basis of interim data analyses.

In this context, EDC allows for a centralised, standard workflow whereby patient data can be easily collected, cleaned, validated and managed. It provides real-time, permission-based access to high-quality data, “which is critical to a time-sensitive process in which only a limited user base may be exposed to the data”, Datamonitor notes.

CTMS software creates a platform for tracking and managing all non-patient information related to the trial. It allows sponsors to maximise usage of clinical supplies based on patient enrolment in each treatment arm, which could change mid-trial, Datamonitor observes.

In all, says the report’s author, associate analyst for pharmaceutical technology Ruchi Mallya, eClinical technologies “play a vital role in the successful implementation” of adaptive trials. These require continuous analysis and monitoring of unblinded clinical data, performed by a group of statisticians and researchers who are not allowed to communicate with the rest of the clinical research team. As such, Mallya comments, eClinical solutions “empower sponsors, researchers and statisticians with real-time data, enabling them to make critical modifications to the trial”.

Interoperability

An eClinical platform consists not only of a CTMS solution but of “a whole suite of systems”, the report notes. At the moment, these systems operate in silos and are connected through point-to-point integrations.

To leverage fully the benefits of these technologies, Datamonitor says, eClinical solutions need to be “built on an interoperable framework that will enable life science companies to run clinical trials in a more efficient manner … An interoperable platform would allow for greater visibility into the clinical research process, and greater collaboration among various departments and stakeholders within an organisation”.

As pharmaceutical companies do not have the necessary expertise in interoperability, they will rely on external input to help them develop this framework, the report adds. This will make vendors that can provide an interoperable eClinical platform the leaders in the clinical technology market.

At the same time, adoption of EDC in particular “requires a major organisational and process paradigm shift”, Mallya warns. While eClinical solutions have been around now for more than 20 years, implementation of these systems has been much slower than initially expected, largely due to lack of support from end-users.

Many researchers and investigators who are used to paper-based systems “are not ready to make that change”, Datamonitor comments. Yet until all stakeholders in clinical trials “are educated on the true features and benefits of modern clinical technologies, and are willing to make the necessary mental and cultural switch, implementation of eClinical solutions will remain sluggish”.