The decentralized model proposes the performance of clinical trials as partially or entirely remote. The main activities of the trial can be driven through technology and require fewer site visits and more remote monitoring. These approach guarantees trial quality and data integrity in the same way as traditional trials, and it has broadened access to more patient-centered operations, engagement, new markets, and real-time data.
Because of the experience gained during the COVID-19 pandemic, we are experiencing a significant increase in clinical trial software and services technology development and usage. As shown in the results of an observational study on Parkinson’s disease in 2020 (1) with 226 individuals, of these, 181 (80%) successfully downloaded the study’s smartphone application, and 161 (71%) completed patient-reported outcomes on the online platform, showing exceptionally high adherence rates.
More and more, the software tools are getting validation and built-in compliance with the good practices framework. Challenges remain regarding the technology adoption among the participants, investigators, and sites teams. Mitigation risk strategies like user-friendly design flows and local training in balance with the interaction and assistance process with the patient are critical to getting positive outcomes in hybrid and completely decentralized trials.
According to Mckinsey & Company (2) most clinical trials won’t be entirely virtual but will use decentralization based on suitability for the endpoints. As predicted in the Industry Standard Research survey in 2020, 100% of surveyed CROs expected virtual trials to be included in their portfolio, and 89% expected to run trial activities in the subject’s homes. Two years later, the hybrid and decentralized clinical trial designs are worldwide.
- Person-centered approach: Participants can provide data anywhere and anytime through apps, APIs, and specialized software, improving the patient experience and reducing drop-outs, for example, due to patients moving to another city.
- Remote monitoring: Closed the geographic distance gap, the investigators can do virtual visits, use telemedicine, and use wearable devices to keep data records without going to sites.
- Real-time decisions: The systems allow more detailed surveillance of the trial, identify timely Serious Adverse Events (SAE) and Adverse Events (AE), and reduce times, speed, and task management.
- Diversity and inclusion: Technology amplifies access to more and more diverse participants, who mostly can’t be reached by the traditional methods.
- Technology amplifies access to more and more diverse participants, who mostly can’t be reached by the traditional methods.
- Efficiency: Reduces time in logistics and gains efficiency in data accuracy, processing, and paperwork. Mitigate human errors.
- Emerging markets access: Technology has contributed to decentralized clinical trial development in regions with less experience but high potential in life science research like Latin America and Asia.
trial in vaccines
Suiting and tailored technological solutions for specific therapeutic areas as vaccines are essential for efficient approaches to decentralized clinical trials. Understanding the expected outcomes and the regulatory context is vital to developing digital solutions that improve the trial flow—for example, considering the strict participants’ surveillance during the first seven days after the vaccine administration.
The maturity in the development of software solutions for vaccine clinical trials makes it easier to find products that can improve and make them more efficient. Critical stages such as enrollment, visits, monitoring, surveillance, and reports require processing large quantities of data and usually represent significant expenses in time and resources.
As the offer of software and services grows, so does the need for more flexible, customizable, modular, and integrated platforms for each stakeholder to have a tailor-made ecosystem.
Integra IT - Software solutions
for clinical trials from end to end
Integra IT is a specialized software and application development company focused on the process optimization and improvement of clinical trial operations. Beyond digital tools, we give our partners trust through data safety, quality, and timely support for their projects.
Since 2009 we have been improving clinical trial execution in more than 15 therapeutical areas, including COVID-19, phase I to IV, and RWE. We have the trust and results of the CROs and sponsors in over 20 countries worldwide, with extensive experience conducting hybrid and decentralized clinical trials in emerging markets. Our technology makes end-to-end data gathering more efficient, with a user-friendly process for staff and patients, and always under the best quality standards from GCP and the FDA 21 CFR Part 11.
- R, Schneider, 2020. Design of a virtual longitudinal observational study in Parkinson’s disease.Wiley Online Library. https://onlinelibrary.wiley.com/doi/full/10.1002/acn3.51236
- G, Agrawal, 2021. McKinsey & Company. No place like Home? Stepping up the decentralization of clinical trials. https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials