Most traditional clinical trials operate under a model similar to: design the trial, conduct the trial, and then analyze the research. This has been the model for most medical research in the past and remains the predominant model to this day. But times change.
There is a newer, more flexible trial structure that is starting to make the rounds through the clinical trial space – adaptive design. Adaptive design offers many benefits to the researchers and the participants in a clinical trial. In this post, we'll break down everything you need to know about adaptive design, along with ways that it can help you improve your next clinical trial.
What is Adaptive Design?
Simply put, adaptive design trials incorporate real-time results from the trial into the trial itself, modifying the trial's design. This feedback loop results in trials that often save time and money by incorporating efficiencies that arise during trial research. An essential requirement for adaptive design is that any changes made during the trial must maintain the validity and integrity of the trial, being careful not to insert any bias into the study results.
Why Aren't Adaptive Design Trials Used More Often?
Despite existing for roughly 25 years, adaptive design trials are still less common than fixed sample trials. This may be due to several reasons, including:
Confusion around how they can be used.
Uncertainty on when to use them.
Not confident in the benefits/results of using adaptive design.
As more people experience the benefits of adaptive design trials, we expect to see more trials embrace this benefit-driving methodology.
5 Reasons to Embrace Adaptive Design
Reduces the Length of the Trial
By incorporating efficiencies and evidence as they naturally arise in the trial, researchers can reduce the length of the trial through adaptive designs. In a fixed design trial, the treatment, and doses, of the patients at the beginning of the trial cannot be changed, despite what may arise in the trial.
This can result in time and resources being misused, as certain groups may respond better to specific treatment doses. Or some groups, at a lower dose, may not respond at all. Incorporating this information can lead to abandoning ineffective doses and focusing instead on dose quantities and perhaps groups that benefit more from the treatment.
Reduces the Number of Patients Needed for the Trial.
Similar to how adaptive design can reduce the length of a trial, it can also reduce the number of patients needed for a trial.
For example, let's say that a dose of the drug being researched is found to be ineffective. In an adaptive design study, the dose can be increased and given to the same patient. In a fixed sample study, this change in dose would likely have to occur in a different study if it wasn't planned from the beginning.
This would result in redundancies and a needless delay in collecting information. But the ability of an adaptive design study to incorporate the change into the same patient sooner reduces the number of patients needed in the trial.
Increases the Speed to Market of Pharmaceutical Drugs.
Since the length of the trial can be shortened, this also increases the speed with which these medicines are made available to the market. This increased speed is invaluable, as it can save people's lives while also resulting in increased revenue for the company.
Reduces the Costs of Clinical Trials.
In addition to the above factors, adaptive design can significantly impact the cost of the clinical trial. By reducing the number of patients and the trial length, the costs of an adaptive design study are also reduced.
On the other side of the equation, revenue is likely to start rolling in sooner since a shorter trial means that the medicine will often get to the market faster.
Adaptive Design Can Be Used in a Variety of Trials
We've been discussing how your team can use adaptive design in early clinical trials. But adaptive design isn't limited to those. It can be used in various trials, from standard clinical trials, to early-stage, to post-market. The main limitation is the ability of a team to track the changes and the data that comes out of these adaptations. And that's where Cloud Concinnity comes in.
How to Reap the Benefits of Adaptive Design?
While the benefits of adaptive design are clear, it is more complex and often has more variables to balance than a traditional fixed design trial. An adaptive design trial requires careful consideration, forethought, planning and more intensive oversight. Data will need to be closely tracked and analyzed, and more meetings will need to occur to communicate changes and other important information effectively. However, the benefits are worth it.
We firmly believe that adaptive design is the way of the future, which means that oversight teams will also need to embrace adaptive design. Luckily, Cloud Concinnity offers a streamlined, cloud-based system that will empower your team with the smart tools they need to meet the oversight challenges of adaptive trials. It also allows for asynchronous communication, which will reduce the need for meetings and allow your team to easily and quickly keep in touch.
To request a demo, reach out to Cloud Concinnity today.