RxTrials welcomes CenterWatch as a guest blogger who wrote the below post:
The following is excerpted from the article “Sponsors target new areas to speed cycle times” by Karyn Korieth, which appears in The CenterWatch Monthly August 2011 issue.
Across the industry, biopharmaceutical company executives struggle to find ways of shortening drug development cycle time.
In the current drug development environment, sponsors place a high priority on accelerating cycle time to improve R&D productivity. Yet median development cycle times, according to analysis of FDA and industry data, increased by nearly 15% between 1994 and 2009, from 77.3 to 81.9 months.
Executives say the greatest challenge to reducing cycle time is the large, phase III clinical trial, having become more complex in terms of number of patients, design, type and frequency of measures, enrollment criteria and the logistics of managing sites in multiple countries. Other trends, such as requirements for long-term safety studies and a movement toward more outcome endpoints also have lengthened clinical trial phases in recent years.
Yet overall, executives consistently cite protocol development, site selection/patient enrollment and improving the decision-making processes as the most promising areas for improving cycle time.
Some companies have set specific targets for reducing cycle times. At Biogen Idec, the overall goal is to reduce theINDfiling to NDA submission cycle by no less than eight-to-nine months versus its baseline. Other companies haven’t set specific objectives, but are constantly asking how they can improve processes.
Accelerating the design phase
Protocol design is a key area. Sponsors are looking to simplify designs, which could help ease site work burden and reduce the number of amendments required, by initiating more informed decision-making early in the planning process.
A recent Tufts Center for the Study of Drug Development (CSDD) study found more complex protocols take 72% longer than less complex protocols from the time the protocol is ready to last patient/last visit. It also found more complex protocols averaged a higher number of amendments; it takes more than two months and costs an average of $450,000 to resolve a single amendment.
Genzyme has just begun a new protocol development process that could potentially reduce cycle time by two months through reducing a study’s complexity. By clearly identifying the endpoints upfront, and what data are needed to meet those endpoints, unnecessary procedures can be eliminated and more feasible protocols can be designed.
Genzyme teams apply a rigorous feasibility process to address challenges associated with access to the target patient population and recruitment in the early planning stages. The initiative sets out a timeline establishing when various committees should sign-off on the study concept.
Forest Research Institute has focused efforts on developing clinical strategy plans early in the process to drive the development of study protocols. “You need to develop a clinical scientific development plan as early as possible,” said Ulo Palm, M.D., vice president of clinical operations and operational excellence at Forest Research Institute. “What is lacking is focus. If necessary, I would send a team to a hotel and tell them they are not coming back until they have written a sound clinical development plan taking all of the different aspects into play.”
Speeding study execution
Across the industry, there is nearly universal attention focused on study execution, especially on study start-up processes, site selection and patient recruitment. According to Cutting Edge Information, site selection and patient enrollment activities consume almost 45% of cycle times.
Sponsors have begun to adopt practices, such as the use of metrics and analytics, that have been used in other industries for years to improve efficiency and productivity.
Forest Research has instituted a detailed clinical development start-up plan, which has accelerated start-up time by three months.
BMS has identified the need to better use analytics, particularly to identify the location of target patients so it can select the right investigators to reach these patient populations. It has an initiative to compile global data sets from insurers, CROs, clinical laboratories and other sources, to give it more robust information for identifying patient populations and investigators.
Genzyme has begun a similar program to better select sites that have a higher probability of enrolling patients for a given study, hiring a feasibility expert who has implemented a formal process to develop data-driven country and site selection strategies. Part of the process, including using data to review the past performance of particular sites.
Astellas has begun to use global templates for its clinical trial agreements that not only reflect the needs of sites, but also incorporate different local regulatory requirements. The site selection process ensures sites actually have the required patient population and the ability to successfully attract and retain those patients.
Improving critical decision-making
Astellas three years ago established a global development committee that includes drug discovery research, commercial and manufacturing representatives who make critical decisions about molecules as they go through development milestones. It is responsible for technical, scientific and budgetary review and decisions and meets every two weeks.
The global project team, which works hand-in-hand with the committee, is responsible for understanding the differing regulatory needs of the main regions where Astellas wants to seek registration and approval, and for creating a single or integrated global development plan. The team facilitates decision-making by ensuring that information flows between the drug discovery and research groups and the global development organization.
What advice would you give sponsors to best improve cycle times?