Practical Considerations in Decentralized Trials

Hybrid clinical trials and decentralized trials have been commonplace in testing various vaccines over the years. Although the COVID-19 pandemic has accelerated the use of clinical trials, pharmaceutical companies were limited in movement and were looking for ways to ensure patients’ safety. Besides, they are to ensure the integrity of the vaccine trials. These trials remain a viable way to get data for medical research. However, before you can get started, there are several considerations that you need to keep in mind to manage the issues discussed above and get quality data.

Understanding the Decentralized Model

You have a choice of three models for your trials: traditional, hybrid, and decentralized. The most popular is the traditional model. Unfortunately, for the reasons stated above, it cannot be used. Researchers and their sponsors face challenges when implementing the latest technologies, processes, and tools to profit from studies.

The research team has to determine the most appropriate technologies for the study, whether telemedicine, mobile, or using local health providers. Each of these methods will differ from a traditional clinical trial. The fact that patients have assessments at home poses a challenge. Researchers must teach them how to use them and ensure that the data they collect is valid. Due to such difficulties, pure DCTS has yet to take root in the industry.

The Design of the Study

The design of the study determines how many decentralized elements are incorporated into it. For example, if you proceed with a highly interventional study, such as when researching neurological or behavioral issues, you may need to conduct several virtual site visits. In some cases, the study cannot be fully decentralized because some qualitative data may not be available through existing technologies.

On the other hand, a low-intervention study, such as weight or blood pressure recordings, is easy to do virtually. When designing the study, keep in mind what information you need to collect, the technology in place to collect it, and ways to ensure you collect accurate data.

Regulatory Considerations

Most countries have enacted legislation to protect DCT participants and ensure the security of the data collected from them. These rules differ from one country to another. If your study includes more than one country, you should know what laws each has put in place. At times, as a scholar, you may have to change the design and delivery of the study when you move to a different country. Check the relevant laws for guidance to eliminate the risk of being penalized.

Managing the Operational Ecosystem

The operation ecosystem includes all the services and tasks you will need when conducting the study. Sponsors are responsible for conducting medical oversight, managing the elements of the study, and protecting the patients under their care. You have to ensure that the patient understands the goal and procedures of the study and stays within the set parameters, such as a prescription for a drug.
They must also be willing to participate in the study and provide the data sought. This approach eliminates any other variable that may affect the results or safety of the patient.

Digital Endpoints

As explained earlier, decentralized clinical research uses new technology for monitoring and data collection. Technology development has made it easier and faster to gather data remotely. You have to choose the endpoints that will collect the data. Start by determining the type of data to collect and the extent to which it will be collected.

Ensure that you pick wearable devices that the target patients are able to manipulate to gather the required data. Besides, check if there are any regulations on the use of any of the devices or the type of data that you can acquire with them.

How to Manage and Manipulate Collected Data

Once you get the data, what you do with it determines the credibility of the findings. You should have a data strategy in place before you start data collection. Data management involves sorting it, cleaning it, applying formulas, and tabulating it for easy interpretation.

Ensure that the devices that collect data are secure from alteration and misconfiguration and do not demand a lot from the recipients. The integrity of data also applies to analysis, manipulation, and sharing.

Decentralized trials have become popular. They enable companies to conduct clinical trials across a wide area. However, scholars should keep in mind the factors listed above so that they can conduct a viable study whose experience and solutions can be used in decision-making.