Adaptive clinical trial design in oncology research represents an intersection of two major industry trends. One of these is the current prevalence of cancer clinical trials. Last year, Clinical Leader cited a GBI Research report that declared oncology the largest therapeutic area in the pharmaceutical industry pipeline. And the promise of immunotherapy continues to galvanize investigations into new cancer treatments. The other trend is the increasing popularity of adaptive trial designs, which have helped the industry neutralize major inefficiencies in their research – not to mention all the discussion and debate they have sparked among industry bloggers and thought leaders.
As oncology research is home to a large share of adaptive trials,1 any challenges to the implementation and execution of adaptive design can have consequences for one of the biggest and most important segments of the clinical research industry. As cancer researchers assess whether they’re equipped to successfully execute an adaptive clinical trial, then, the stakes could hardly be higher.
The impact of electronic data capture
The ability to manage a modern clinical trial hinges in large part not just on whether a trial uses an electronic data capture (EDC) solution, but on what that particular solution is capable of. Indeed, not every EDC can handle adaptive trial designs smoothly. Some, in fact, pose significant inefficiencies, requiring studies to be taken completely offline while protocol changes are implemented. This creates a major delay that many trials with strict timelines can’t afford.
Luckily, that delay is ultimately unnecessary – more modern and savvy eClinical solutions offer features that are much more conducive to adaptive trial design. Those features include:
- The ability to make mid-study changes in real time, affecting only the relevant sections of the relevant forms without bringing the entire study to a halt.
- The ability to test changes in a development environment before researchers deploy them, with the study, meanwhile, continuing undisturbed.
- Beyond EDC, eSource products can allow protocol amendments to be imported directly to the application, without requiring any tedious manual copying.
EDC brings the capabilities necessary for adaptive trials to data managers – eSource extends those capabilities all the way to the sites. And with adaptive trials on the rise, the ability to handle them smoothly is an invaluable asset for an eClinical platform.
Why this matters for oncology
Adaptive trial design is on the rise across various segments of the clinical research industry. It’s no surprise, though, that they’re pursued to such a high degree in cancer trials. The nature of oncology research, as well as the state of the field today, offer a number of possible explanations for this trend:
- Innovations such as immunotherapy have brought new uncertainties to oncology, and researchers can benefit from the ability to modify protocols as they learn.
- Challenges in patient recruitment and retention are notoriously daunting in cancer trials. If a trial misses the enrollment target set in the protocol, or the enrollment total changes due to attrition, the ability to integrate those changes seamlessly into an eClinical system can be an important lifeline.
- The urgency of cancer patients’ conditions, even in Phase I, make the question of whether the treatments in the trials actually work even more consequential. Traditionally, researchers don’t know if a dose is effective until the end of data collection – adaptive designs allow them to modify dosage sooner, increasing the chances of effectiveness.
As the trend toward adaptive trial design continues, it will become more and more important for researchers to ensure they have the tools necessary to reap the benefits. eClinical technology plays a major role in this process. Whether researchers possess the right EDC for the job could be a major factor in whether they can keep up with a challenging and evolving field like oncology or lag behind, struggling with the same challenges that have frustrated the field for years.
1 Hatfield, Isabella; Allison, Annabel; Flight, Laura; Julious, Steven A.; Dimairo, Munyaradzi; Adaptive designs undertaken in clinical research: a review of registered clinical trials; BioMed Central; 19 March 2016