Increasing the speed and efficiency of investigator site contracts and budgets
The Tufts Center for the Study of Drug Development recently estimated that the average cost to develop a new drug and gain market approval now approaches $2.6 billion, with the largest portion of that sum attributed to clinical trials. A separate study by KPMG asserted that the return on investment (ROI) of biopharmaceutical research and development (R&D) has dropped from 20% in the late 1990s to 11% today, with only one in every 10 investigational drugs being approved by the FDA.
At WCG, we aim to increase the ROI of R&D by improving the efficiency of clinical trials. One area in which we’ve made significant strides is in the negotiation and execution of investigator site contracts and budgets. By streamlining the development of these critical but administratively burdensome processes, we are able to help clients avoid costly delays, maintain more productive relationships with investigator sites, and ultimately speed the delivery of potentially life-saving therapies to market.
Clinical trials are comprised of a vast matrix of different services that occur at overlapping intervals. In the most successful trials, interrelated services are strategically coordinated, and study teams facilitate clear, frequent and proactive communication across multiple operating units, service providers and sites. A lack of communication or in the coordination of services can result in costly delays. An amendment, for example, is often a consequence of poor communication. Studies show that one-third of all amendments are avoidable, resulting in nearly $2 billion per year of unnecessary expenses. To ensure clear communication, the most efficient contract negotiators create templates which reflect the priorities and preferences of the sponsor, including country specific facets of contract language. At WCG, we find that the more information we have at the onset of a trial, and the more frequently we work with a client, the more effective we are at controlling their timelines and costs.
As clinical trials become increasingly complex, clinical trial agreements (CTAs) have become longer and more intricate. The key to navigating these intricacies, especially in a dynamic international landscape, is the retention of local legal expertise. At WCG, we employ a network of global attorneys who understand institutional policies, compliance regulations and country-specific laws. Residing in over 60 countries, these seasoned, trained negotiators are familiar with local language and customs, and work at maintaining positive relationships with site personnel. They are also proficient in budget strategy, understanding how fair market value and standard of care analysis may be interpreted differently by various sites. By engaging these experienced, in-country experts, we are able to reduce the overall amount of time and money that our clients spend on negotiation.
Our innovation is a proprietary, end-to-end technology solution that enables the efficient coordination and management of contracts and budgets, providing clients with greater visibility into each activity. And through links to electronic data capture (EDC), invoicing, reporting and banking systems, our technology facilitates the timely and accurate execution of investigator payments. The Clinical Trials Transformation Initiative determined as many as 40% of sites drop out of clinical trials due to lengthy delays in payments. In addition to supporting trial operations, it aids in the collection and analysis of data, which clients use to leverage valuable insights and drive continuous process improvement.
Based on our experience, the average timeline to execute a CTA is 129 days. Some delays are out of the sponsor’s control, like country-specific regulatory requirements or academic institutions with long signature processes. But many are not. To improve overall efficiency, we focus on optimizing the elements of the process that are under the sponsor’s control. Methodical, accurate and realistic planning in the early stages of a trial is what enables our clients to move forward with accuracy and speed. In addition, they benefit from improved relationships with sites, as sites prefer working with sponsors who are committed to alleviating administrative burdens and are capable of issuing payment in a timely and accurate manner.
Every week lost to negotiation is a week during which patients are not enrolled and data goes uncollected. These delays must be prevented. Not only do they impact the timelines and cost of the trial, but more importantly, the lives of patients and their families.