This post originally appeared on the Bio-Optronics Blog
The analysis of patterns in clinical trials has indicated that studies are becoming increasingly complex. Over time, more and more procedures are included in protocols, and these procedures are increasingly complex. Frequently, amendments are added to protocols, further complicating the implementation of the desired protocol.
In addition, adaptive trials are predicted to gain traction in the next several years. In fact, many CROs and sites have already expanded their capabilities to accommodate adaptive trials. Adaptive clinical trials are another effort to reduce waste in clinical trials. In this design, protocols can be optimized or changed midstream as data is collected. According to the Journal of the National Cancer Institute, the types of adaptations “can be to drop a treatment arm that isn’t effective, alter dose levels, or increase the trial size if a drug proves less responsive than predicted.” The belief is that many trials fail because the protocol is not optimally designed, making it difficult to tell if an IMP is actually effective. The FDA and industry are pushing for adaptive trials because they are expected to be more efficient that traditional studies.
Adaptive trials are expected to encourage more patients to enroll in studies. In adaptive trials, if a treatment is working with the initial trial participants, later enrollees are more likely to be given the medicine over a placebo. It is proposed that patients will prefer the increased chances of receiving a new treatment and will be more likely to enroll.
Nevertheless, adaptive trials and otherwise complex trials will require more time and effort by staff be spent on administrative tasks. Ideally, a technology could alleviate the administrative burden of increasingly complex trials, leaving staff to focus on patients.
The right CTMS can help sites, CROs, AROs, other research networks, and sponsors simplify their workflow and the complex environment around them. The investigative staff should be able to easily add procedures to the protocols, and change them as needed. A product should provide flexibility that can handle many amendments and will allow the user to determine when each is activated and can apply the changes going forward.