Clinical trials—the process of testing the safety and efficacy of new drugs—are costly and complex undertakings for pharmaceutical companies. A trial can cost hundreds of millions of dollars and require the coordination of many patients, physicians, and regulatory agencies for up to seven years. The stakes are high not only because companies spend about 10 percent of their operating budgets on these trials but, more important, because they derive huge benefits from being first to market with a new type of drug. In addition to threats from similar compounds, pharmaceutical companies face competition from generics once their patents run out. Patents are issued before a drug goes into clinical trials, so the faster a trial goes, the longer the pharmaceutical company enjoys a monopoly until generic versions can be sold. Thus, a streamlined and speedy process for trials can have a major impact on the economics of new drugs and of existing drugs that may be approved for additional uses after further clinical studies.

Over the past decade, pharmaceutical companies have introduced a number of initiatives to boost the productivity of clinical trials. One of these initiatives has been the rollout of electronic data capture (EDC) systems, which allow patients and researchers to enter their trial information directly, either in electronic diaries or online systems. Other efforts include the adoption of new scientific approaches, such as Bayesian techniques¹ that enable pharmaceutical companies to refine their designs for trials from one stage to the next. In addition, companies have improved their technological capabilities—especially connectivity—at clinical locations by allowing trial managers to keep tabs on the retention of patients and the progress of trials. They have also improved their ability to conduct trials on a global basis, by vastly increasing the pool of researchers and patients. And they have adopted more disciplined procedures for managing trials, in some cases borrowing techniques (including “stage gates,” which set firm deadlines for gathering data and refining the goals of subsequent stages) from product design.

End-to-end improvements in the performance of trials remain elusive, however, especially in the early stages. First, many companies are not coordinating a number of trials across their organizations as well as they could. The lack of cross-trial transparency can create delays when different trials compete for scarce resources. A second reason is that many organizations haven’t yet embraced reusability by streamlining their approach to the design of trials. Certain components of the forms that guide researchers in trials could be shared and reused across a number of them, but many companies haven’t integrated the principle fully. Third, although electronic data capture systems have substantially reduced the time required to gather data on trials—to 2 weeks, in some cases, from 20—first-generation systems were not always flexible or reliable enough to suit investigators’ needs. In addition, verifying electronic data to ensure that they correlate with physical data (such as lab test reports) remains time consuming. Finally, the productivity measures some pharmaceutical companies have implemented apply only to parts of the organization and thus fail to capture all of the benefits.

In recent years, some leading pharmaceutical companies have begun to ease the bottlenecks and raise productivity by revisiting IT systems to streamline the process further. Such efforts are most successful when companies take a comprehensive clean-sheet approach, integrating their systems in an end-to-end redesign of the whole trials program (Exhibit 1). The application of these principles has sped up trials by 10 percent or more for some companies. In addition, a number of them have applied principles from lean manufacturing to these information flows, improving their throughput and reducing waste by redesigning their clinical-trials processes, staff responsibilities, and technology. Certain companies have improved their speed, quality, and costs by focusing on getting the right data the first time, managing work flows to reduce bottlenecks, and making data more transparent across the entire clinical process.

Through our work with these pharmaceutical companies, we’ve identified four areas in information and process design that are ripe for improvements to make clinical trials faster and cheaper:

• the integrated planning of clinical trials across a given company to improve the way resources (for example, clinicians and biostatisticians) are allocated to clinical teams
• tools to create electronic case-report forms (eCRFs) rapidly by taking advantage of modular designs and reusable components
• the enabling of physicians to use electronic data capture tools more effectively by providing more training, customer support, and a standard interface
• an integrated architecture for information systems, to make trials visible to management from end to end and thus to execute more effectively by eliminating bottlenecks

Developing an integrated plan

Pharmaceutical companies design trials within individual therapeutic areas, but trials in all of them draw from a pool of shared functions. Coordinating these resources efficiently isn’t easy given the dynamic nature of the trials portfolio, the challenge of creating the right cross-functional teams from the shared pool, and the difficulties of recruiting investigators² and patients. To complicate matters, program managers for trials often attempt to reserve more resources than they need in order to ensure that the actual requirements will be available. What’s more, when trials are canceled, newly freed-up resources often are not redistributed efficiently to ongoing efforts. These factors all make the use of a company’s resources less than optimal, which limits its ability to initiate new studies or to complete ongoing ones as rapidly as possible. Developing an integrated plan across therapeutic areas to address these issues can cut costs and speed up the completion of trials: one large pharmaceutical company identified potential savings of $50 million to $150 million from improving the way it allocated resources across projects (Exhibit 2).

The transformation from ad hoc planning to an integrated approach requires a comprehensive program that addresses the cultural, process, and systems barriers to change. Five elements are critical:

• Senior managers signal their support for integrated plans by insisting, very visibly, on the use of standardized processes and systems.
• All project managers follow a common process that formalizes the way the company creates, approves, controls, executes, and ends trials.
• A flexible approach to planning allows project teams to plan at whatever level is clear to them—an entire program, a project within a larger program, or a bundle of tasks within a project.
• Forecasts of the use of resources are based directly on project plans.
• Common standards for detailed descriptions of work activities help allocate resources more efficiently and specifically.

Each of these elements has implications for information technology. IT platforms for enterprise project management³ play a major role in enabling a company to develop and manage a more integrated approach. In addition to linking available resources and trial schedules automatically, the platform serves as a repository of design templates for trials, enforces standards, and helps improve work flows.

Designing trials rapidly through modularization

One result of integrated planning across therapeutic areas is that companies are beginning to standardize their processes and tools for designing and recording a trial and to guide the investigators who conduct it. Designing a trial begins with determining its objectives (that is, what the researchers are hoping to prove about a new drug) and describing the type of patients and physicians it will require. Designers of trials then work with colleagues—within the company and in partner organizations, such as contract research organizations that help coordinate trials—to convert these objectives into a series of documents, including the patient consent form, the list of lab tests to be conducted, and the case report form that physicians fill out during the trial.

Although there is a robust culture of independence among designers of trials, several factors are encouraging standardization and reuse throughout the design process. The first is the recognition that integrated planning helps make better use of an entire organization’s resources across trials. Creating reusable modules that can be used in a number of studies (for example, a standardized approach to designing and collecting data about a drug’s safety and any adverse effects) saves time in subsequent designs. Senior managers, recognizing this opportunity, are often strong advocates for the shift to modular design.

Second, the advent of electronic data collection creates an incentive for designers of trials to modularize the process in order to minimize the cost of developing and integrating electronic case reports for each one. First-generation electronic data collection systems created some unforeseen fixed costs. Before they came on the scene, for example, information was collected manually, so the person recording it could easily spot and correct obvious errors early in the process. Programming electronic data collection systems to identify these errors through a series of checks is time consuming and generates additional start-up costs for trials. Standardized error-checking modules allow such checks to be built once and reused many times.

Third, collecting data in a standard form makes it easier to perform analyses early in a trial. This, in turn, allows project managers to see early findings and to make interim decisions about the rest of the trial.

Tailoring electronic data collection to investigators’ needs

Once the design is complete, managers (often a contractor) must recruit and train investigators to undertake the trials. In most cases, the investigators must balance competing demands: the extra effort required to conduct cutting-edge research with the need to devote sufficient time to manage a practice and care for patients. Conducting efficient clinical-research trials is therefore a primary concern for investigators. Any improvement in efficiency will help pharmaceutical companies sign up leading practitioners.

In recent years, investigators have become increasingly frustrated by electronic data collection systems, which, they say, create more work than the old-fashioned pen-and-paper system did; for example, reliability issues have forced them to keep data both ways. Doctors and nurses also complain that they lack adequate training in the systems—a problem complicated by the fact that every company uses its own proprietary systems.

The pharmaceutical industry could improve its ability to sign up physicians by making data collection systems more friendly to investigators in several key ways. First, companies should gather and track the preferences of investigators at different sites in order to understand how physicians want to use electronic forms. The companies should then ensure that the systems are flexible enough to accommodate these preferences. If some leading researchers insist on staying with pen and paper, designers of trials must make sure that there is a solid process to convert the data to standard electronic forms (perhaps in a low-cost remote location).

Likewise, companies should standardize the way they collect data not only within their organizations but even across the industry (see sidebar, “A Sabre for pharmaceuticals?”). This move will shorten the learning curve for physicians, as they will have to learn the electronic-entry system only once.

Finally, companies should redefine an important factor in trials: the role of clinical-research associates. In the current model, associates primarily monitor programs. Instead, they should become more active problem solvers who manage the relationship between the organization conducting the trial and the investigators. As part of this shift, the incentives for the role of associate should be realigned so that they are no longer based merely on the number of visits to sites but also reflect metrics for speed in recruiting patients and the quality of the data gathered.

Streamlined work flow and end-to-end trial visibility

The fragmented IT systems and data architecture⁴ of most pharmaceutical companies make it extremely difficult for managers to track productivity throughout the trials process. Project managers for trials might be able to reduce bottlenecks in the availability of patients, for example, if those managers could see the patient-recruitment pipeline. But although they have access to the clinical-trials-management system, the data on patient recruitment are usually kept in a separate system for electronic data capture—or sometimes even on paper.

A single real-time view of all the relevant data on trials can help companies overcome these barriers. Vendors hope to integrate their offerings and provide a more complete solution, but this task may take some time. Until these systems are more mature, companies should continue to take a best-of-breed approach and invest in middleware tools that help exchange data among systems. A “dashboard” that displays key metrics in a spreadsheet or some other easy-to-view form can also help managers keep tabs on the bigger picture.

Even across a number of systems, companies must work to streamline and unify the way they manage work flows. Automated notification—such as alerts in trials-management systems to warn when data entry has been delayed—is one example of how IT can help managers coordinate projects in order to make sure that bottlenecks don’t occur. Alerts could also help trigger coordination across functions to keep processes moving without delays.

Finally, a standard interface can help pharmaceutical companies analyze and compile trials data received from a number of different partners that manage studies within a single program. Currently, each third party might use its own data standard. Standardizing within a company (and across the industry) could make it easier to exchange data and speed up trials.

A significant opportunity to speed up clinical trials awaits pharmaceutical companies that build on the foundations of the first wave of electronic data capture systems. Changes of this scope are never easy, and legacy systems can act as a drag on new solutions. The companies that enjoy the most success in implementing the kinds of changes described in this article tend to do so as part of a broad change program anchored around a solid business case. These companies envision a comprehensive redesign program rather than isolated fixes and often take the opportunity to implement productivity-improvement schemes such as lean or Six Sigma. Finally, they create new roles and redesign incentives where necessary to encourage new kinds of behavior.