The Decentralized Clinical Trial Model
COVID-19 sure did shake things up in the healthcare industry. Surgeries were cherry-picked based on priority and level of urgency. Hospitals were over capacity. Nurses were exhausted. Doctors were stressed. During the beginning of the pandemic, clinical trials were strained as well as medical staff were stretched thin while trying to balance attending to both COVID and non-COVID patients in addition to clinical trial patients. Moreover, in-clinic visits added more risk to the clinical trial patients when they went in for labs or drug administration. Fortunately, home health services were able to alleviate some of the stress. Because of this service, patients participating in clinical trials were not put at risk of getting COVID and were able to receive treatment in the comfort of their homes.
As more and more organizations catch on to the decentralized clinical trial model, new technology is developing to make these home visits even more convenient and feasible. Typical issues that affect traditional clinical trial models include, but are not limited to, patient inconvenience and employee manpower. The decentralized model increases access to trials which creates convenience for those who were inconvenienced in the traditional model and decreases the work volume for clinical trial staff. Subsequently, the patient could potentially participate in a clinical trial 100% from home.
Technology and the Decentralized Model
While the decentralized model opens doors that were otherwise closed, technology is evolving which could essentially take the door off the hinges. Innovations such as telemedicine, monitoring devices, and data analytics are predicted to make the decentralized model even more appealing. The goal is to make the clinical trial process more patient-centric while reaching more diverse populations to acquire the most accurate data.
Telemedicine has become more popular than it had been before the pandemic while healthcare offices limited traffic to reduce the number of COVID-19 cases. This allowed patients to call and speak with a provider about their health. Services like Teladoc®, give patients the opportunity to call a hotline to be connected to a physician. Patients who are too sick to go to the doctor, cannot get an appointment soon enough, or just want to reduce the chances of getting COVID-19 are able to get virtually examined through a simple phone call. Considering clinical trials, sites can screen patients over the phone or even online. During the trial, follow-up appointments can also be conducted virtually, and patients complete their surveys over the phone or online, without having to physically visit the site.
Monitoring devices make patient visits go a little smoother and help reduce costs of physical visits. Because most monitoring devices needed during a clinical trial visit are now portable and inexpensive, nurses can bring these devices with them to visits or even send them to the patient to self-monitor and report any irregular measurements. Monitoring devices have saved both clinical trial staff and patients’ time and money which improves accessibility.
As more data is collected from patients, researchers gather more information about patients and their conditions and artificial intelligence can use that information to match the patient to the clinical trial that would be the most effective1. Data Analytics can also play a role in patient education. Patients get a better glance at their health and increase their understanding of the trial essentially improving retention rates.
Medicine is forever evolving with new innovations and advancements. As new and better ways for treatment are being discovered, the patient remains priority. If there is a way to make patient interaction and participation easier on the patient, the goal is to find it. Utilizing technology in the decentralized clinical trial model is a step in the right direction, but there is plenty of room for improvement. However, it is safe to say researchers are on to something!
References
Delisle, M. (2021, Sep. 29). 3 Ways Digital Health is Transforming Decentralized Clinical Trials. Hit Consultant. Retrieved October 12, 2021, from https://hitconsultant.net/2021/09/29/decentralized-clinical-trials-innovations/#.YWW42mLMJEY