Decentralized trial designs are the future. They solve most of the challenges traditional clinical trials face, including delayed timelines, lack of patient diversity, and unending costs. The pandemic illuminated most of these problems, but the Veristat researchers tried to work around the lock-down while recruiting qualified patients in their clinical trial design. To counter these challenges, researchers had to change their study formats and ensure they reach people where they are while maintaining flexibility, increasing diversity, and accommodating technology and direct data sources.
Decentralized clinical trials require clinical trial planning that augments and replace traditional clinical approaches with data-driven alternatives. Hybrid clinical trials have seen widespread adaptation while increasing emphasis on home care and the ability to access larger populations while driving lower overall trial costs. What strategies do clinical research organizations need to adopt to take their clinical trials to the future?
Use technology
Decentralized clinical trials are centered around incorporating technology. Technology accounts for the proper management of trial product supply and ensures that the patients are in adherence and compliances. You should include wearables, smartphones, and access to tele-visits together with home and healthcare providers, including nurses, phlebotomists, and your healthcare providers. It is also essential to integrate clinical trial activities that can be completed easily using NLP (Natural Language Processing) and AI (Artificial Intelligence) thus helping you identify a diverse set of trial participants.
Data collection
Clinical Research Organizations must work with different patient service companies to guarantee accurate data collection. Patient data in decentralized clinical trials is often fed through mobile phone devices, in-home, and in-clinic visits, and in some cases, extracted from electronic medical records (EMRs). The data is aggregated, translated into study reports, and prepared for regulatory review. Sometimes this data can be unstandardized and difficult to use. Using machine learning and AI to translate and format the data can make it easy to use for reporting purposes.
NLP technologies can also help your CRO access unstructured clinical notes, making them more accessible and usable for researchers. It is essential to manage patient data from multiple clinical trial sites or digital technologies with intuitive, fit-for-purpose technologies with a regulatory requirement expert or in partnership with a data science company. CROs are also exploring using RWE (real-world evidence) based on RWD (Real-world data) to help reduce time frames, expenses, and complexities associated with bringing medical solutions to the market.
Reducing the patient’s burden
CROs must work with their partners to create protocol design that incorporates patient-centeredness. This helps to reduce the burden on patients. Decentralized clinical trials make it easier for patients to participate in the clinical trial in the comfort of their homes using technology with study-specific educational information. Increased ease of the trial process leads to improved patient retention, which is crucial in maintaining study timelines.
Clinical trials will incorporate more technology in their trial process to reduce the timeline and increase the chances of success. You need to research the different choices you have at your disposal and determine how they will best work for your company.