Can Smarter Study Design Meet the Recruitment Challenge

By Ed Miseta, Editor-in-Chief, Clinical Manager
Follow me on twitter @EdClinical

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Recruitment has always been a challenge for companies conducting clinical trials. Corporate sponsors looking for new ways to engage and recruit patients have had varying degrees of success. But could this challenge be mitigated or eliminated through smarter study design? A recent Town Hall by Halloran Consulting Group in partnership with Exploristics attempted to answer this question. City Hall, organized by Meaghan Powers of Halloran Consulting Group, brought together Aiden Fynn from Exploristics, Akil Jackson from BergenBio and Alan Menius from Spencer Health Solutions. The discussion produced some interesting questions and takeaways regarding clinical trial simulations.

The importance of simulations cannot be ignored. There are problems that exist in clinical trials that are not going to go away. The answer to these problems cannot be to spend more money or collect more data. This, unfortunately, will put more of the burden on patients at a time when drug companies are trying to make trials more patient-centric. The solution could be for companies to have a more informed and holistic approach to study design. Simulations could help provide them with this approach.

What are clinical trial simulations?

Clinical trial simulations use mathematical models to describe a system or process and are then used to test and evaluate the process under different sets of conditions. The performance of the process can then be evaluated. A simulation can provide insight into the success and failure factors, help quantify risks, and enable the development of mitigation strategies.

Several factors have guided the evolution of test simulation in recent years. The group notes that the main drivers have been the interest of regulators, the increase in access to the data needed to develop realistic simulations, increased computing power, the increased acceptance of cloud computing in the pharmaceutical industry and a new generation of statisticians with multidisciplinary skills well suited to building simulation capabilities.

Decentralized trials have been a hot topic over the past year, with the pandemic forcing many corporate sponsors to allow patients to participate in trials remotely. One concern that has been expressed about this approach is the quality of the data collected. Since data is collected from patients’ homes rather than clinics, corporate sponsors need to know whether the data collected is complete and of good quality. Simulations allow companies to examine these issues, understand what to expect, and how the data collected would impact the overall study.

Adoption and challenges

In order to implement a clinical trial simulation, the right expertise is required. Speakers noted that the platform is designed for statisticians or someone who is very familiar with statistics. Over time, as an organization develops increased capabilities, it can develop a hybrid model.

There will certainly be barriers to adopting simulations. First, the group notes that employees like the status quo. They like to do things a certain way and will be reluctant to do things differently. This is a situation that businesses will have to overcome. As one panelist noted, the old method no longer works. Change is needed, and drug developers will need to invest the time and effort required to set up simulations. Over time, the investment will lead to cost savings, less burden on patients, and a greater level of confidence in a study. Hopefully the simulations will also lead to a decrease in the number of test failures.

There is work that will be required to set up a simulation tool. To be successful, the simulation tool will require early engagement with statisticians to develop the testing protocol and strategy. All available knowledge will be collected from the start to build a large virtual and synthetic population that captures risk factors, outcomes and what-if scenarios.

Regulatory concerns

With any adoption of new technology, there are concerns about whether the FDA and other regulators will accept the changes. The same goes for simulation-based design methods.

The panel noted that the FDA encourages companies to use model-based drug development. Simulation is an important part of this. Simulations can be performed before companies even engage with the FDA. Discussions with the FDA can be seen as a negotiation, and it is preferable that these negotiations be quantified rather than based on opinions. The simulations will give businesses the data they need to make these discussions more tangible.

Of course, the first step in implementing any new tool is to get senior management approval. The panel also gave advice on how to proceed.

When presenting the tool to executives, focus on saving time and the ability to quantify risks. Then turn the discussion on the expected impact of the tool. Demonstrate how a clinical trial simulation will help build a smarter study, generate better data, and minimize the risk of a study failure that will need to be repeated. It can also help with patient recruitment because it can better quantify and communicate potential benefits to patients.

For more information on this town hall and others, contact Maria Coakley, Events Manager, Halloran Consulting Group, at [email protected]

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