A Systems Approach to Clinical Research
As other industries have found, an integrated global system of common standards, regulations and procedures acceptable around the world, with a focus on safety, ethics and quality, brings order into chaotic situations, benefiting everyone.
Over 60 years ago, the situation in the air transportation industry was much like that of the clinical research enterprise today. There were no universally accepted standards or processes for the complex array of operations necessary for global air transportation–flight paths and scheduling, safety regulations, baggage handling, passenger management, ticketing, boarding, training of pilots and staff, emergency procedures.
In 1944, despite deep differences and competing interests, 52 countries signed a convention to provide the foundation for a global system.
Today the International Civil Aviation Organization (ICAO), the International Air Transport Association (IATA) , the International Association of Travel Agents Network (IATAN ) and other like-minded organizations have worked together to build a global system spanning the globe. One-hundred ninety-one nations, along with many industry and aviation organizations, vendors and service providers collaboratively develop international Standards and Recommended Practices (SARPs), allowing over 100,000 daily flights to operate worldwide with safety and efficiency.
It is the integrated, interoperable nature of the global system for air transport that makes possible air travel as we know it today.
In the clinical research enterprise, such a system would bring order from the current chaos and dysfunction afflicting clinical research. Of necessity, such a system must be constructed collaboratively by stakeholders from all areas of the research enterprise for it to be a true system, one with its own Standards and Recommended Processes (SARPs) ensuring safety, efficiency, quality, interoperability, effectiveness…in a word, excellence.
The existence of such a system will:
- Drive and reward standardization. The existence of a system provides direct incentives to create and adopt standards to reduce variability, improve connectivity and interoperability.
- Promote and value professionalism. Sponsors, CROs and regulatory agencies have all come to realize that sustainable sites with professionally trained and educated personnel perform at a higher level and with fewer deficiencies, and they are willing to recognize and reward such professionalism.
- Drive regulatory simplification and innovation. An effective system that allows for enhanced, timely, remote assessment of compliance and safety data will allow regulatory agencies to be more effective and to develop innovative new mechanism for oversight of trials.
- Enhance performance through increased efficiency and reduced redundancy. Implementation of simple standards-based data collection processes has been shown to reduce study start-up time and duration by as much as 36%.
- Promote and enhance safety and quality. Real-time availability and access to performance, compliance and safety information from clinical trials allows early detection and analysis of important signals that may indicate problems even before harm is done, thereby permitting corrective action to be taken in a more timely and effective manner.
- Recognize and reward excellence. An effective system of accreditation allows top performing sites to distinguish themselves from poor quality sites, streamlines monitoring and oversight processes and supports the payment of a premium for quality, thus providing an incentive for achieving and maintain excellence and enhancing sustainability.
- Reduce costs of development and time-to-approval. By enhancing the efficiency and quality of the clinical trials process, a global system will shorten the time required for site selection and qualification, reduce study start-up time, reduce time devoted to frequent, often redundant monitoring visits, and improve data quality to facilitate the new drug approval process.
- Align ethics with good business and scientific practices. When doing things right results in significant financial rewards for all stakeholders and improved life-quality and health for the people of the world, there are no losers.
- Increase transparency and improve public trust. Accreditation is a proven tool for substantiating and building public trust. A more effective and timely process for oversight of research and the attendant reduction in deficiencies and scandals will further improve public confidence and participation in the enterprise, including capital investment.
Promote investment in sustainable research capacity in emerging nations and markets. Strong incentives exist to expand clinical trials activity in developing countries, at least in part to access markets for products in those countries that have traditionally neglected health needs. Alignment of these incentives with a rational approach to capacity building is a win-win opportunity.