EDC evolution

What factors are currently impacting on the pharma industry today, specifically the area of clinical trials?

A range of pressures, including those related to market, regulatory/safety, consumer pricing, and capacity issues, influence the industry on a domestic and global level. Sponsors must attempt to finance a pipeline of drugs, develop and support a blockbuster, and complete volumes of clinical research in the most economical way. While the clinical development cycle has been regarded as a cost of doing business; given all the pressures today, sponsors are asking how they can afford to address these challenges and are seeking new ways to reduce costs. They are asking 'How can we complete clinical development and sustain the growth trajectory we?ve committed to, given our amount of resources and bandwidth? Ultimately, how can we get more clinical trials through the pipeline?'

There is, however, real potential to address these challenges with a positive outcome through the effective use of technology. For example, proactive management of study resources, including monitors and clinical sites, is feasible in real time in an electronic data capture (EDC) trial, in contrast to paper trials where relevant information is often delayed or unavailable.

How has the demand for EDC changed within the last few years, and what has driven those changes?

Demand has grown dramatically in recent years because sponsors increasingly realize its value in addressing the pressures mentioned above. As with every new technology, EDC was initially piloted by visionaries in the pharmaceutical industry, who recognized its potential value and were willing to deploy it on a limited basis to determine its benefit – far ahead of the majority. The ?pilot? phase for EDC has now ended – the technology has been tested and proven over the past few years, and sponsors are increasingly confident in its capabilities. Sponsors initially saw the benefit of EDC as a way to more effectively capture clinical data at the source, but then quickly realized that making clinical data electronically available allows them to manage and analyze information for faster decision-making and optimization of their resources. As a result, we are seeing our customers transition from using EDC on a few studies into implementing EDC as the standard for the way they run all their trials.

With this in mind, how important a step are clinical trials in bringing new drugs to market?

Large sponsors are looking to save money on the development cycles of existing pipeline of compounds, and smaller companies are looking for overall improvements to process and throughput. For both, it?s critical to create efficiencies in the clinical trials process. In addition, pharma and biotech companies will want access to information sooner during the clinical trials process to make decisions about whether or not to proceed ? the earlier a sponsor can eliminate spending resources on drugs that won?t succeed, the better. As soon as possible, sponsors need to confirm that products are safe and effective. The number of products that are successfully brought to market are in the minority of compounds that enter into trials, making this early visibility a major factor to a pharma?s investments.

So what role does your company play?

Medidata?s Rave platform provides three main benefits – a complete clinical data management solution, an easy-to-use, easy-to-deploy EDC system for high site satisfaction, and early visibility into both performance of compounds, as well as the management of resources. Rave allows pharmas to run all of their clinical trial operations, regardless of the study phase, geography or language requirements, on one global platform. Whether it?s a Phase I or long-term surveillance study, the trial can be optimized by using Rave to help control the process and cost.

What challenges are pharmas hoping EDC will solve in the future?

For years, the clinical development space has been filled with various point solutions. Much as we?ve seen in the enterprise resource planning (ERP) space, the evolution of these point solutions into full platform solutions was not an easy transition. Likewise, the pharma industry will be challenged by cycles of integration and redesigning, including changes to clinical development processes. As sponsors are looking to replace these legacy clinical development point systems with global, enterprise-wide solutions, EDC will grow into an enterprise platform that interfaces with other development systems, such as enterprise ERP and clinical trial management and safety systems.

Besides the technology, pharmas will ask EDC vendors to evolve the way they provide services and support to meet the demands for global, enterprise-wide deployment. Vendors will need to operate both locally and globally, to be aware of the regulatory issues concerning both. They must understand that regardless of the sponsor?s geographic footprint, the issues they face are global issues, specifically in terms of regulatory factors, cost, and patient recruitment. For instance, if we?re working with a sponsor in Germany, Medidata is also able to manage issues in Asia, Africa, the Americas or elsewhere.