One change in clinical research everyone is feeling is the consistent increase in the complexity of protocol designs for new studies. Regardless of the causes of this increase in complexity, it is something research organizations need to effectively manage in order to remain efficient and profitable. This task is often easier said than done. Complex protocols have a negative effect on data quality and analysis, cause greater amounts of unused trial data, increase dropout rates, and lower physician participation levels. What’s worse, complex protocols often become more complex as a trial progresses. Oftentimes, multiple protocol amendments are made on a single study, especially on long term studies, such as oncology related studies, which can cost hundreds of thousands of dollars to implement and waste months of time.
For any organization involved in the research process, it is important to keep up with the constant changes in your trials so you can minimize loss and maximize efficiency. In order to meet these requirements, research organization managing complex or regularly changing protocols need a CTMS with the ability to adequately manage dynamic and adaptive protocols.
An all too common issue researchers’ faced with adaptive trial designs (ATD) is how to manage the complex protocol designs. Paper and MS Excel methods for managing complex and changing protocols can be nearly impossible. This is why dynamic and adaptive protocols are necessary. The right CTMS can provide the necessary solution for research organizations in this scenario. A 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. Here are just a few ways that a CTMS with dynamic and adaptive protocols can help oncology trial management.
Cost and Time Reductions
Using CTMS to manage ATDs 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.
For more oncology related blog articles, check out Oncology’s Clinical Research Complexities: Understanding Cost Allocation.