A novel approach to trials is attracting more interest among medical device companies and regulators looking to streamline the clinical trial process.
Unlike the traditional double-blind trial model, adaptive trial design allows researchers to continuously monitor data from the trial and use it to make changes to the trial while it's still running.
This allows for several advantages that could help make trials more efficient. For example, if the data showed a high likelihood of futility then researchers would be able to end the trial early. This would be particularly helpful for clinical 3 trials, many of which have a low success rate coupled with high expense.
Another adaptive design protocol, interim analysis, allows researchers to examine their study data at planned intervals and use that to determine whether or not to make pre-specified changes — for instance, adding a new treatment into the device regimen that has already been cleared with regulators at the start of the trial.
This protocol sidesteps the 10-12 week long lag times involved in making changes to a traditional trial. "This approach may allow manufacturers to secure some insurance for their cutting-edge device, allowing them to make changes to the study before it's even over to ensure that their investment is being used effectively," said Vicki Anastasi, senior vice president of medical devices at Aptiv Solutions, to DOTmed News.
Of course, this approach isn't without its downsides and pitfalls. Because researchers are able to get an early look at data, companies that are publicly traded may receive heightened regulatory scrutiny, for example.
Some companies specializing in trial design product solutions like Aptiv try to account for this challenge. "AptivAdvantage allows firewalling of this data so you're getting to your decision point quicker but you're also doing it in a secure manner," said Corey Dunham, senior vice president of global data management at Aptiv Solutions.
There's also the problem of altering the trial outcome: in other words, tweaking the study multiple times increases the risk that the results turned in to the FDA will show a false-positive outcome.
And altering the study halfway through may also send a signal to doctors and patients in the trial that the study isn't going as planned — an interpretation that may lead to study bias and a change in the results.
Nevertheless, it looks like adaptive trial adoption is due to see an upsurge among device firms seeking to preserve and allocate resources more effectively — an advance made possible in large part by recent breakthroughs in computational algorithms and computing speed. Other technology-driven trends such as remote data management are also helping drive better clinical trial efficiency, according to experts.
