While adaptive trial designs have been slow to gain traction, there a many benefits to adopting this trial model. While fear from additional FDA scrutiny is a major concern for many research organizations, it is not the sole reason why the industry has not seen a more widespread adoption of adaptive trial designs. These reasons include having difficulty managing the more complex trial designs and difficulty communicating changes across all of the organizations participating in a particular trial. While not all problems can be addressed by a clinical trial management system (CTMS), utilizing a CTMS in the management of adaptive trial designs can greatly benefit a research organization.
Manage Complex Protocol Designs
An all too common issue researchers’ face with adaptive trial designs is how to manage the complex protocol designs. Paper and MS Excel methods for managing complex and changing protocols can be nearly impossible. The right CTMS can provide the necessary solution for research organizations in this scenario. 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.
Cost and Time Reductions
Using CTMS to manage adaptive trial designs can also provide significant reductions in time by streamlining processes and eliminating unnecessary administrative tasks. In conjunction with the reduction in time, a significant cost savings can be achieved for research organizations.
In any clinical trial communication between partners is critical to the success of a trial. This is especially try in situations where the protocols of a trial can change in a moment’s notice. CTMS systems can play a major role in improving communication between research organizations. As protocols change everybody can be automatically notified to ensure that everybody is operating off of the same sat of protocols, ensuring trial accuracy.