Study: New protocol designs lead to better trial performance
By Mia Burns (email@example.com)
Increasing protocol complexity is responsible for longer clinical study times, greater difficulty in recruiting volunteers, and rising drug development costs. This trend is spurring new approaches to optimizing protocol design, according to leaders from the research-based drug industry recently convened by the Tufts Center for the Study of Drug Development. Associate Web Editor Mia Burns spoke to Kenneth Getz, director, sponsored research programs, CSDD, Tufts University School of Medicine about the changes and their impact.
Q: What are some of the specifics of the new protocol design approaches for clinical trials?
A: These new approaches fall into several primary areas. Some organizations are just beginning to recognize the problem and the opportunity. They are trying to benchmark their own internal study design practices against published data from the Tufts Center and against robust metrics provided by organizations like Medidata Solutions. Benchmarking offers an opportunity for companies to really understand how their designs compare to general industry practice. Do they have too many endpoints for example? Too many procedures?
Companies that are farther along tend to create internal mechanisms and new governance models to proactively assess the feasibility of their protocol designs. We’re seeing newly formed committees made up of cross-functional teams that are empowered to evaluate the cost and feasibility of performing various procedures. These mechanisms look at ways to reduce the number of procedures that are not associated with a primary or key secondary endpoint. These new governance committees will play an essential role in optimizing study designs and, ultimately, they will assist organizations in improving study performance, efficiency and quality while lowering cost.
Q: What could be done to curtail protocol complexities within clinical trials?
A: Ten years of research at the Tufts center has informed the identification of key opportunities. But our research is centered around a very simple concept: Everything we do to simply study design will ultimately improve performance, quality, cost, and efficiency. It’s an unusual win-win. Spend less on procedures – specifically extraneous ones – through simplifying, prioritizing, and optimizing study design. As a result, we will complete the study faster, collect better data, and we get our treatments into the hands of patients much sooner.
One key opportunity area identified is reducing protocol amendments by focusing on more extensive assessment of study design feasibility before putting the protocol into the clinic. Too often, investigative sites start working with the protocol before the sponsor has finalized the study design or before the sponsor realizes that the protocol is too difficult to implement and enroll. As a result, protocols are frequently amended and this is very disruptive.
Another key area is reducing the number of procedures that are not core to the study objectives. Many protocol procedures are not collecting data that will support the primary or secondary data endpoint. Roughly every one in five procedures is exploratory in nature. To reduce the number of these specific procedures alone will have a huge impact on improving study performance, quality and cost.
Q: What are some examples of the internal governance mechanisms that drug developers are implementing within their clinical trials?
A: Internal cross-functional committees are becoming widespread and they are empowered to review and modify the protocol while it’s in the design phase. These committees challenge costly procedures that are not central to the objectives and the endpoints of the study. Many of these committees rotate their members based on availability and expertise. A growing number of major sponsors are creating this new governance capability that fits within the protocol review and approval process. Early reports on the impact of these committees are very promising with strong cost and time savings reported.
Q: What are some of the changes occurring within the organizational structures?
A: Feasibility review committees are probably the biggest change. I think the other is the growing realization within companies that the optimization of protocol design is an absolute necessity for their long term success. It’s a critical advantage for them to get better at challenging and improving protocol feasibility.
Q: How do drug developers review the key design elements and collect new measures?
A: Some of the specific metrics that companies are gathering to assess the effectiveness of their feasibility assessment processes include cycle time improvements and the cost savings by not performing certain procedures. Some companies are also looking specifically at reducing the number of protocol amendments that they typically must implement.
Posted: October 2013