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’s something research organizations need to effectively manage in order to remain profitable and conduct quality research. 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, which can cost hundreds of thousands of dollars to implement and waste months of time.
If you are a research site, academic research organization, CRO, or any other 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 quality. Below are a few ways a CTMS application helps lessen the impact from complex trial protocols. Be sure to consult CTMS vendors on how their application can help you take control of your study protocols.
Consent Form Management
The best CTMS applications will allow you to ensure all patients in a trial are up-to-date on the latest consent forms. You can see which patients have signed the latest form and those that have not, and you can avoid wasting time and money conducting procedures on those why aren’t on the latest consent form. This is an important step because it will allow your organization to minimize unused trial data and will help keep costs as low as possible.
Adaptive and Dynamic Protocol Management
Many studies today involve multiple arms. It’s important you have a CTMS that can account for the addition of multiple arms, this way you and your team can effectively track the visit requirements for each visit on every study arm you are running. This functionality also makes billing for visits and procedures much easier and repeating visits simple to schedule in the system.
While protocol complexities increase the likelihood that patients may drop out, a CTMS can work wonders to keep them informed on every stage of the trial. Visits can be scheduled, patients can be paid more quickly and you can even send them messages that keep them informed as soon as possible on any changes in the trial.
A CTMS allows your research partners to more easily integrate with you, making the whole research process more efficient for all parties because protocol amendments can be distributed to easily. What’s more, your partners can send necessary information to everyone else through the CTMS, which facilitates faster adoption of a protocol amendment and mitigates losses of both productivity and money.
If your organization has multiple locations running the same study, then you will want a CTMS that can take a study protocol from a central location and distribute it to every location running a particular clinical trial. This eliminates the risk of inaccurate protocols and eliminates time wasted by entering data multiple times. This functionality makes investigator-initiated studies more feasible as well, as an investigator’s location can push the created protocol to a central location and onto other sites running that trial.