Dose escalation studies have been used as a cornerstone in medical research to determine the most effective dose of a drug. They are usually part of early-stage, phase I clinical trials. But like so many things in our world, the COVID-19 pandemic changed how researchers approach dose escalation management. The immediate demand for a healthy, effective vaccine showcased the need for evolving best practices and spurred researchers to adopt new technologies.
These advances have spread beyond the COVID-19 vaccines and will likely reverberate throughout the field. So to best prepare you for the future of dose escalation management, we break down these changes and the new technologies below.
How Does Dose Escalation Work?
In phase I trials, dose escalation works by finding the most effective dose of a drug; that which prevents patients from being exposed to harmful or sub-therapeutic doses of the drug.
This is a fine line to walk.
As researchers seek to avoid harm, patients are often put on lower doses that are often sub-therapeutic. The dose amount is then increased, to better identify effective doses while minimizing any harmful effects to patients. This process requires diligent management and careful consideration of all the factors involved.
Why Is Dose Escalation Important?
If the dose is sub-therapeutic, precious time and resources are misused, and the patient isn’t given effective treatment as the dose isn’t high enough to be beneficial. On the other hand, if the amount is too high, the patients may be subjected to unnecessary risk, discomfort, and unpleasant side effects.
Dose escalation seeks to find the effective dose by slowly escalating the doses in different patient groups. However, this requires the expertise and ability to manage and analyze the data of different patients within different groups by researchers while allowing these researchers to communicate effectively and quickly.
That’s a lot to manage! Luckily, this is where the Cloud Concinnity Platform comes in.
The Importance of Technology in Dose Escalation Management
The implementation of dose escalation in phase I clinical trials requires the close monitoring of each patient’s dose and response to these doses, along with various other factors. The necessary data to track quickly adds up. So how can technology help your team manage these factors?
Providing Patient Data at Your Fingertips
Cloud Concinnity offers a solution to these problems through an easy-to-use, cloud-based software that allows an oversight committee, such as the DMC, to see what’s happening with individual patients and their dosing. This clarity of information and detail of data is invaluable when determining the correct dosing for a patient and ensuring that a study’s resources are utilized as effectively as possible.
It also allows committees and teams to make better decisions about whether or not the study should proceed. If a statistically significant number of patients aren’t responding to treatments or, worse, are reacting negatively, this will be readily apparent. This can save time, resources, and money in ending or reworking ineffective trials early.
Reducing Administrative Burden
Moreover, technologies like Cloud Concinnity reduce the administrative and operational complexity of dose escalation trials by allowing teams to keep track of patient data and communicate quickly and effectively. And, since this is all cloud-based, it’s available for any researcher to access while also providing a central point of access.
Increases Communication
These trials often require more meetings and communication between researchers, as the nuances in the data brought about by dose escalation spur debate or discussion between researchers. Luckily, we’ve created the ability for them to meet asynchronously with the Cloud Concinnity Platform, which saves valuable time and increases the power of the team to communicate effectively.
Standardizes and Automates Processes
Many of the changes brought about by the COVID-19 pandemic aren’t going anywhere any time soon. And while the need for the most efficient, safe, and effective trials utilizing dose escalation management was prevalent before the pandemic, they are even more critical now. Researchers are using dose escalation management techniques in various fields.
This increased focus on dose escalation management means that teams will need smarter process management software to help them navigate these studies designed to find the correct dose for a drug that can potentially save millions of lives. And the best way to manage dose escalation trials is with software like Cloud Concinnity, which provides the cloud-based flexibility and ease of communication that will help your team succeed.
While other platforms may offer communication or documentation, Cloud Concinnity provides the security and capabilities to meet the compliance requirements of a clinical study. If you have any questions or would like to see a free demo of our software, please get in touch with us. We are here to help.