Industry Perspective:
Q&A with Steve Kent, President, Perceptive Informatics
The changing landscape of clinical technology
Steve Kent is President of Perceptive Informatics, the industry’s foremost eClinical solutions provider and the technology subsidiary of PAREXEL International. He was previously Chief Executive Officer of ClinPhone, a leading clinical technology organization that was acquired by PAREXEL in 2008. In a recent interview, Steve discussed the rapidly changing landscape of clinical technology.
How has the clinical technology landscape changed over the last decade?
Although the biopharmaceutical industry was relatively slow to adopt clinical technologies when they were first introduced, that pace has accelerated rapidly in the last decade as companies began to realize the benefits these systems could bring to the drug development process. Over the last few years, the capabilities of clinical applications as well as integration techniques have advanced, resulting in an even more dramatic increase in the use of clinical technology. Just two or three years ago, more than half of all clinical trials were still using paper CRFs and other manual data-gathering processes. Today, it is estimated that more than 70 percent of trial data is collected electronically – a clear demonstration of the importance of clinical technology solutions for today’s clinical trials.
The global pharmaceutical marketplace has also changed substantially over the last decade. Competition has intensified. Development costs have increased dramatically. The cost of failure for pivotal clinical trials is higher than ever. Regulators, health providers and insurers are demanding more information about new products. To meet these challenges, biopharmaceutical companies must continue to find new ways to improve the efficiency and accuracy of every part of the drug development process. Most importantly, sponsors need to make earlier – and better-informed – decisions about their development portfolio to improve the success rate of products reaching later-stage trials.
While standalone clinical trial technology systems have significantly improved efficiency and data quality within specific parts of the clinical development process, they are limited in their ability to share information and reduce redundant data entry. This lack of data integration and interoperability is preventing biopharmaceutical companies from reaping even greater rewards from their technology systems, such as improved support for “go/no-go” decisions, greater trial productivity, and accelerated product development.
In recent years, the focus in clinical technology has shifted from individual systems to the development and implementation of multi-function, integrated eClinical solutions that provide greater value for sponsors than systems used in isolation. There is a growing utilization of “middleware” such as a Clinical Technology Integration Platform (CTIP) to improve clinical technology interoperability and integration, with the goal of delivering the comprehensive data biopharmaceutical companies need to gain greater visibility into trials and improve their decision making.
What are customers’ top clinical technology needs today?
As noted above, our customers in the biopharmaceutical industry need more integrated eClinical solutions that simplify workflow and provide easier access to important trial data and metrics. A CTIP addresses some of that need by facilitating the exchange of information between various clinical technologies and delivering key clinical data that site personnel can view through a single, centralized access point. Another way we are simplifying data access and improving the efficiency of clinical technology use for our customers is through what we call “product convergence”. Product convergence is the concept of making functionality that belongs to one application available through another. An example would be having the ability to randomize subjects, dispense and re-supply medication and provide emergency replacement packs for subjects through an EDC interface without having to log into IVR (interactive voice response) or IWR (interactive web response). This convergence of technologies allows users to perform their most important day-to-day activities using a single system and interface, without logging in and out of multiple applications – an improvement that increases the efficiency of clinical technologies and streamlines the workflow of site personnel, while also enhancing the user experience.
With the increasing size and scope of clinical trials, our customers also need technology solutions that are easier to use and less costly to implement. Large late-phase clinical trials – which may enroll thousands of patients at hundreds of sites around the world – present a particularly difficult challenge for clinical technology. To be successful, the system must be able to accommodate large numbers of patients, be simple enough to be used by site personnel with a wide range of technical abilities, and able to be implemented quickly and cost-effectively at numerous sites. Web-based clinical trial portals are well-suited to meet the requirements of these large multinational studies, which is why they are a rapidly-growing solution for many global biopharmaceutical companies and CROs. Portals also provide 24-hour-a-day support for data access, site collaboration and communications – benefits that are particularly important in light of the growing globalization of clinical trials.
The other major area where technology can address sponsor needs is in early-phase testing. With the high failure rate of new compounds in pivotal clinical trials, biopharmaceutical companies are increasingly relying on early-phase research such as Proof of Concept studies to more quickly and accurately select drug candidates with the greatest chances for success in later stage trials. Advanced eClinical technologies are essential to the success of these early testing models – providing real-time data to support adaptive trials designs and other innovative approaches that can help accelerate drug development.
What is the future of eClinical?
As we look ahead, the trend toward greater product convergence and data integration will continue to accelerate. Workflows will become more streamlined, allowing users to feel that they are working within a single application to perform most of their functions, even as they access data and functionality from various clinical systems. Software providers will expand their efforts to offer a suite of clinical products that share a common interface that will reduce learning times while increasing productivity. At the same time, delivery models will shift from traditional on-premise and hosted ASP to Software-as-a-Service (SaaS), providing rapid deployment and flexible pricing, as well as access to platform technologies such as reporting and identity management.
Reaching the next level of clinical technology will require a combination of integrated systems and innovative clinical services to create a new operating model that increases efficiency across the development spectrum. This combination of technology and services will require a provider with a wide range of clinical development services that are fully enabled by technology – an “eCRO” in the terminology of some industry experts. By leveraging the best available technologies and combining them with clinical expertise and a global infrastructure, eCROs would be able to marshal all the necessary resources to help a biopharmaceutical company reduce the time and cost of clinical development at every stage of the product lifecycle. These broad capabilities will be essential to support the trend toward larger and more complex Phase III and Phase IV trials being carried out on a global scale.
Ultimately, we expect biopharmaceutical companies to increasingly focus on the outcomes they want to achieve, and be less concerned about the specific technologies that are used to reach those goals. Sponsors will rely on a select group of partners for comprehensive solutions that combine clinical technologies, services and expertise to deliver the desired result – allowing biopharmaceutical companies to concentrate their internal resources on key tasks such as basic research, product acquisition, and market expansion.
