The suite life: The future of clinical development

By Martin Young, Senior Vice President, Integration and Product Strategy

Over the last several years, the pharmaceutical industry has been fundamentally transforming its core business model of producing "blockbuster drugs" aimed at large patient populations with high sales potential.

“To achieve significant R&D efficiency and capacity gains, sponsors are increasingly looking for an integrated suite of solutions that can automate the management of the entire clinical development process across all phases of development”
-Martin Young

Over the last several years, the pharmaceutical industry has been fundamentally transforming its core business model of producing "blockbuster drugs" aimed at large patient populations with high sales potential. While the industry thrived on this model for decades, the market opportunities for blockbuster drugs have been diminishing. For pharmaceutical and biotech companies to continue to grow and remain competitive, they need to bring a greater number of products to market in order to address smaller, more specialized patient populations.

Regulatory requirements, however, are consistent regardless of the size of the intended patient population, which keeps the cost of bringing a new drug to market relatively equal. As one might expect, testing more drugs and running more trials concurrently increases overall R&D costs and creates additional resource challenges. A key requirement for any new development model, then, is increasing R&D efficiency and output. Of course, this is easier said than done.

Today's clinical trials are more complex than they were just several years ago and require the management of incredible volumes of electronic data. Trial sponsors have increased their use of technology in almost all areas of clinical development, including patient recruitment, drug supply chain management, study design development, patient reported outcomes and pharmacovigilance, among others.

While all these tools have streamlined various individual processes and are helping the pharmaceutical industry achieve greater R&D efficiency, taken as a whole, they have the potential to create a complex layer of data and vendor management that could derail any of the efficiencies gained. Employing and integrating a myriad of disparate point solutions from different vendors can be a daunting and expensive task.

To achieve significant R&D efficiency and capacity gains, sponsors are increasingly looking for an integrated suite of solutions that can automate the management of the entire clinical development process across all phases of development.

What's in the basket?

While most sponsors recognize the inherent delivery and user efficiencies gained from employing a technology suite, to truly be effective, each component has to be a best-of-breed solution that can stand up against any comparable individual point solution. A suite is only as strong as its weakest link, and a sponsor will find limited value in an integrated solution if the principal technology does not meet its standards. To cover the full breadth of clinical development and pharmacovigilance, the technologies outlined below are some of the core, best-of-breed applications that need to be included.

Electronic data capture (EDC) was the first notable innovation that helped drug companies achieve greater efficiency and is a fundamental technology in clinical development. EDC systems automate the collection and validation of clinical trial data in-stream to explore the efficacy and safety of a drug. This technology facilitates near real-time access to clinical study data, giving better visibility into information collected.

To help organizations better manage their supply inventories, interactive response technology (IRT) solutions (or IVRS/IWRS) automate and centralize the overall supply chain for randomizing subjects and dispensing medication kits. This technology is particularly important for reducing drug waste and reducing overhead, both in large-scale studies with thousands of patients and in small biotechnology studies where the cost of the biopharmaceuticals used can be quite expensive. Randomizing patients-that is, associating patients with particular treatment arms, assigning them patient IDs and issuing them the right medication kit-is a critical process required for the majority of Phase II and III studies.

Study design tools leverage standards and templates to simplify the process of building a study. Designers can reuse study components, such as forms, code lists, and rules, from one study and apply to another study with similar requirements. Actual research cannot begin until all the stakeholders-data managers, biostatisticians, site staff, etc.-agree that the design satisfies all requirements. Abbreviating the duration before a trial can go live is a significant value to trial sponsors.

Electronic patient reported outcome (ePRO) technology is an efficient method to capture data directly from patients. Subjects can enter data either through a PDA device or directly over the Internet on any computer they have access to. Paper-based collection methods are costly, logistically challenging and can discourage patients to continue to participate in the trial. With ePRO, organizations receive more accurate data and better visibility into the collection and analysis processes, which can help improve compliance with trial protocols.

Heightened regulatory oversight and business needs have also magnified the need to improve patient safety and manage risk more proactively throughout the duration of a trial and during post-marketing studies. Organizations are looking to identify and report potential safety problems quickly and efficiently. To accomplish this they need tools for adverse event reporting, data mining, signal detection and evaluation, and tracking of safety issues. These tools give better insight into data and allow safety professionals to make product decisions based on a much broader range of empirical data than previously possible.

The Glue that Binds

With the massive amount of electronic information generated to bring a new drug or device to market, controlling this information from multiple collaborators, while maintaining an audit trail, is extremely difficult. Integrating the data alone is not enough. Workflow integration must also be accomplished. When there is workflow integration, the process of linking data to the downstream analysis and reporting processes becomes much more efficient and gives better control to study management. For a suite to be truly viable, then, there needs to be a central repository to aggregate, transform and store all the collected clinical and operational data, as well as a statistical control environment that can automate the statistical analysis, reporting and submission processes.

A clinical development technology suite that would allow a sponsor to access one system for all clinical data; automatically validate and transform data; simplify data aggregation; automate the analysis process; and streamline the submission process would ease much of the pain facing the pharmaceutical industry as it transitions from the blockbuster development model to leaner and more varied R&D strategies.

Experience has shown numerous other instances where industries have relied upon particular applications to automate business processes and ultimately pushed the evolution of the point solutions employed into a software suite. The same thing appears to be occurring in the pharmaceutical industry. When the suite concept fully takes hold, new levels of efficiencies should be realized that will help drive down the cost of bringing drugs to market.