Best Practices: Five Key Levers
By: Barbara E. Tardiff, M.D., M.B.A.
Corporate Vice President, Clinical Research Services
Five key levers to improve clinical trial decision-making and operations
Faced with growing financial and competitive pressures, biopharmaceutical companies are seeking new ways to increase productivity in every phase of clinical development. While there are many ways to improve clinical trials, here are five proven “levers” that have helped many companies achieve cost and time efficiency improvements in clinical development through better access to comprehensive, integrated information, as well as enhance the alignment of expertise, processes, and technologies:
Lever 1: Embrace the imperative to change the way clinical research is conducted
Many processes in biopharmaceutical development are recognized as being inefficient. These inefficiencies are rooted in the traditional separation between clinical care and clinical research, bottlenecks in data flow, and the heavy demands placed on investigative site resources that are responsible for providing clinical care in addition to conducting research studies. Substantial efforts are underway across the biopharmaceutical industry to change the way clinical research is conducted so as to improve pipeline productivity, decrease critical path cycle times, and reduce the cost of clinical trials. For example, globalization of development provides access to a larger pool of investigators, sites, and patients. Advances in technology enable clinical development teams to make better use of their time and leverage the knowledge of experienced resources. Lean methodologies are being applied successfully in many areas, such as manufacturing. The key to leveraging these available and emerging improvements is to embrace the need for change and commit to a cooperative effort throughout the organization to implement new ways of operating.
Lever 2: Recognize that information is the currency of drug development
Information is the true currency of drug development. More effective management and application of data is fundamental to improving biopharmaceutical product development. With the right information at the right time, resources can be better utilized to increase efficiency and reduce redundancy. Analytics also play an important role in identifying opportunities to optimize cycle times. Greater visibility and understanding of data earlier in the development process can significantly increase the probability of project success and improve the predictability of development plans by providing early detection of issues that could jeopardize milestones and deadlines. A holistic approach to managing the flow of operational and decision-support data is vital for optimizing development processes and impacting project goals.
Lever 3: Be open to process innovation
Cost and time savings can be achieved through innovation that promotes automation, streamlines processes, and improves the alignment of resources. The ability to scale processes efficiently is critically important to facilitate the transition of small, early-stage studies to later stages of development, and shorter process times are achieved by rethinking the coordination of information and work flows across functions and through various systems. For example, data from an Electronic Data Capture (EDC) system, a Clinical Trial Management System (CTMS), and a Safety/Adverse Event Reporting system can be used to enable the automatic, systematic adjustment of the frequency and content of trial monitoring – providing a purpose – and data-driven approach that allows trial resources to be applied where they have the greatest impact on enrollment, data quality, and regulatory compliance.
Lever 4: Focus technology on solving problems, instead of just deploying new features
A solution-focused approach to the implementation and execution of technology is critical to improving trial efficiency. Eighty percent of efficiencies are derived from improving processes and ensuring that staff have the skills and tools to perform their tasks quickly and efficiently. For example, near real-time access to data and consistent performance metrics is needed to provide timely and informed in-trial problem solving. The solution is a well-designed, integrated eClinical platform built to support the dynamic monitoring of data throughout a clinical trial. Using an EDC is a first step to improve visibility into data and product safety during the conduct of a clinical study – in large part because EDC systems have accelerated standardization efforts and helped establish data transfer protocols based on those standards and the use of other eClinical technologies. An eClinical platform leveraging EDC and standards ultimately should provide access to data and consistent performance metrics that support timely – and better-informed – in-trial problem solving, which helps maintain efficiency throughout a clinical development program
Lever 5: Keep an eye on the goal: Improving overall development success
Ensuring the smooth flow of data – supported by the tight alignment of systems and activities – is critical to achieve faster operations, greater information accuracy, and better program management in clinical development. Proactive program management is a key need for developmental improvements. The business processes in clinical development are complex, and extend across multiple functions and organizations. Better use of technology and the application of data standards will help minimize data errors and redundancies. Additional benefits accrue from alignment and integration of activities across technologies to enhance delivery of information and support better decision-making. Program management improvements – including improved technology and more efficient processes – should directly lead to the larger goals of reducing development costs, accelerating time to market, and increasing the success rate of biopharmaceutical product development.