A Rapid Cure for Pharma's Phase IV Trials

Eclipse Uses SAS^® Software to Help Extend the Longevity of Top Brands

Bringing new drugs to market is traditionally cited as the greatest challenge to pharmaceutical companies. Yet in recent years there has been a massive shift in emphasis towards maximising the value derived from already-approved drugs, for example by exploiting newly discovered indications, or entering new markets.

Clinical research has been slow to respond to this shift: most clinical research organisations (CROs) remain overwhelmingly focused on Phases I, II and III and do not understand the unique characteristics of post-approval Phase IV trials. The Clinical Data Management (CDM) systems developed for Phases I-III typically require huge investment and massive resources to set up and maintain; they are cumbersome and ill equipped to respond to the needs of the market.

Pascal King, Founder of the Dublin-based clinical informatics company Eclipse puts it like this: "Using a traditional CDM system is like piloting a super tanker - it takes a long time to adapt and change course. That may be appropriate for regulatory studies but when you are conducting Phase IV trials you need the agility of a speedboat." Eclipse has built a new business model by delivering that speed and agility through SAS software.

Developing new drugs does not of itself guarantee success in today's business environment: competitors are snapping at your heels in next to no time. It may take an average of € 900 million over ten years to develop a new product, but pharmaceuticals companies will often spend that amount on marketing in the first year after approval. Likewise they want to drive maximum value from a product before its patent expires and the generic producers move in. From a return on investment perspective, it may be better to spend money on extending the longevity of an established brand rather than gambling on R&D. "Pharmaceutical marketing is getting more and more like fast-moving consumer goods marketing," says King. If a pharmaceuticals company identifies enhanced efficacy over the competition within a particular market segment, it wants to get that information out as fast as possible."

Phase IV trials address this new reality: they are essentially market expansion programmes to open up new geographical markets, to find new applications for an existing drug, or to secure a niche position in a crowded market. "Phase IV trials are an important element in the marketing mix," says King. The problem has been that clinical research people are too busy with regulatory trials and have been slow to adopt the new mindset; some have regarded Phase IV as not being as scientifically rigorous as Phases I-III.

Consequently most of the Electronic Data Capture (EDC) and CDM companies serving clinical research have remained focused on the older generation of "super tanker" technology - systems designed for trials programmes spanning many years.

That has begun to change with the Food and Drug Administration (FDA) now insisting that every chemical entity coming onto the market has to go through Phase IV trials. Whereas pre-market trials are typically conducted on a pool of some 3,000 patients, once the drug is on the market you can look at the incidence of adverse or positive events on several million people. The FDA wants to see more and more scientific tests of drugs that are actually being prescribed by doctors at a frequency of the doctors' own choosing. According to the US analyst Center Watch, Phase IV trials are the fastest growing sector of all clinical trials, outstripping Phases I to III combined in terms of new study starts.

"Our objective at Eclipse has been to offer a solution that meets both marketing requirements and the demands for scientific rigour," says King. For example, a pharmaceuticals company might discover that a product is particularly suited to the elderly because it has few side effects. A Phase IV clinical trial should enable the company to demonstrate this proposition convincingly through scientific investigation that will satisfy senior clinicians.

Eclipse needed a solution that could turn data around quickly, offering flexible data manipulation tools that would address marketing needs and satisfy the FDA. "SAS is the only software in the world that meets these criteria," says King. "The FDA has a vendor-neutral policy but it is a long established practice for industry to submit data to regulators in SAS data set or transport file format. So from the very outset we decided to build our business on SAS. It meets the needs of marketers, and it gives peace of mind because it is the software that researchers trust.

"The Eclipse Clinical Data Management (ECDM) solution is entirely based on SAS software and brings together a complete package of fully validated data management and analytical tools tailored to the needs of clinical informatics companies like Eclipse," says King. "We felt it was important to get these back-end capabilities right first."

The other part of the equation was to build a secure front-end that would enable rapid web-based data capture and a high response rate from participating doctors. "We wanted to make it as easy as possible to enter the data. As easy as buying a book on amazon.com." Eclipse has broken new ground in this direction; for example, it has built the first Phase IV data collection solution with a true multi-lingual capability, so that doctors can enter results in their own language. Data is also validated automatically with a series of built-in checks. "One of the benefits of making the solution user-friendly is that it helps to promote a positive image for the brand."

Responsibility for this aspect of the business fell to CTO Stephen Booth, who had built up experience of internet front-end and back-end development in the financial services sector. Booth applied this experience to remove all of the paper and time-intensive manual interaction that has traditionally made clinical trials a long, drawn-out process.

Eclipse can therefore offer its customers a Phase IV solution that speeds up every aspect of the process: capture, analysis and publication. Benefits include the ability to meet tough marketing deadlines (for example, advertising, editorial and event-driven deadlines), faster entry into new geographical markets and more timely repositioning of products to better exploit key market segments. In each case, speed and responsiveness is key to driving extra revenue to the bottom line. King believes that Eclipse's unique proposition will also increasingly appeal to smaller Biotechnology companies seeking to reduce costs during earlier trials phases, especially Phase II.

Meanwhile in less than three years Eclipse has grown to become Europe's leading Phase IV clinical informatics company, with a US office and plans to enter the Asia-Pacific market. "We've done this by combining SAS technology with our own deep understanding of clinical research and pharmaceuticals sector marketing," concludes King.