At one time, going to the doctor’s office was the only solution to seeking medical attention and diagnosing health issues. We used to be without a second option when consulting a medical professional was in question. However, that seems like a whole different era now. Today, we have multiple options when it comes to medical advice, and most of them do not require the patient to go to the doctor’s clinic physically. Telemedicine plays a significant role in providing flexibility and convenience to doctors as well as patients for providing and receiving medical attention from a distance. To put it more simply, Telemedicine is the concept of remote diagnosis and treatment of patients by using telecommunication technology. Today, many hospitals and clinics offer their patients the option of getting their diagnosis and cure online through medical platforms and more such equipment. 

A significant branch of telemedicine is Decentralized Clinical Trials (DCTs)  which revolve around conducting clinical studies with the help of telemedicine and local healthcare providers. A Decentralized Clinical Trial involves digitally executing all aspects of a traditional clinical trial. Collecting patient consent, segregating patient data, creating diverse groups for the study as well as monitoring the progress of the clinical trial are all done online, with the help of telehealth technology and state-of-the-art software and platforms- that can be accessed by both patients and healthcare professionals running the Decentralized Clinical Trial. 

Decentralized Clinical Trials have changed the face of health trials and clinical studies since the COVID-19 pandemic due to the increase in trial activities conducted remotely. A McKinsey article in 2021 stated that the DCT reduced the patients’ need to visit the clinic by up to 80%. 

Our experts at Mahalo Health have curated all the necessary information you must know about DCTs today to help you get acquainted with this relatively new concept that is catching on in the medical industry. Read ahead!

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How are Decentralized Clinical Trials relevant today?

Prior to Decentralized Clinical Trials, Traditional Clinical Trials were conducted by clinics to diagnose health conditions and find cures. Traditional Clinical Trials were organized by clinics/hospitals where patients had to be physically present at the trial site to register and participate. The biggest drawback of Traditional Clinical Trials was that only people from areas near the trial site could participate. Besides, participants had to visit the trial site on a regular basis so that doctors could examine them and record their results. This was a tiring and time-consuming process because there was a low turn-out rate, which affected the results since doctors had a meager sample to examine. A research study in 2021 mentioned that more than 70% of the participants lived at least 2 hours away from the clinical trial site. 

Additionally, TCTs were quite expensive since the organizers were required to maintain a physical facility for patients to visit, along with resources that could manually record the progress, problems, effects, and more. 

Following are the phases of a clinical trial that have been integrated into Decentralized Clinical Trials as well, thus making them relevant and much needed in today’s post-pandemic world.

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1. Geographical boundaries and Screening

Decentralized Clinical Trials differ from TCTs in the most basic and root concept. While traditional clinical trials are limited to recruiting a particular diversity of patients from nearby areas and require the participants to be physically involved in testing and recording data, DCTs eased the entire process- from enrollment to tracking progress by implementing the concept of telehealth through and through. Basically, DCTs are human clinical trials but have utilized novel telemedicine technologies to operate and derive quick but efficient results without limiting themselves to particular demographics or locations unless required for research. 

The patient screening is initiated through a multi-layered screening process, where subjects are required to fill out an elaborate questionnaire and sign an eConsent form if qualified to participate. The eConsent form comes with the option of integrating all the existing health records of the patients in the Electronic Data Capturing system (EDC). This system helps clinics avoid the additional costs of testing the patients before enrollment. 

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2. Patient Recruiting and Onboarding

For patient recruiting, DCTs have employed a digital, multipronged approach that includes digital advertising and marketing to reach out to their targeted segment to participate in the trial. Individuals have the liberty to register themselves on study portals with the help of websites, applications, or digital kiosks. They are also provided with all the necessary information, detailed description, compensations, benefits, and a lot more about the study so that they are well-educated about what they are signing up for. On the other hand, Traditional Clinical Trials required physical onboarding of patients by conducting offline seminars, setting up kiosks, and handing out printed literature to the participants, which was not only expensive and overuse of resources but also inconvenient for the patients. 

Patient onboarding has been made very convenient and safe for DCT organizers as well as for patients. While TCTs required participants to simply meet the qualifying criteria, get a review by medical personnel, and sign the consent form, the onboarding process for DCTs is much more elaborate and trustworthy. DCTs have employed various digital platforms and tools to remotely verify the patients, onboard them into the study, provide them professional support, store their data, and monitor their condition. 

Participants of Decentralized Clinical Trials are given around-the-clock virtual support through email, chat, in-app messaging, and on-call counseling. Additionally, to eliminate fraudulent activities, the patient onboarding process includes participant identity verification that captures and stores their biometrics and other vital information. 

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3. Patient Monitoring

Traditional Clinical Trials required participants to visit the trial site to receive their treatment, diagnostics, and professional guidance, and the patient data was regularly recorded on the on-site database. 

However, the medications, therapy material, and other necessary equipment are shipped to their registered addresses upon implementing the decentralized model. At the same time, study details and patient data portals are accessible to patients online. Additionally, DCTs also promote the use of user-friendly data-capturing devices such as eCOA (Electronic Clinical Output Assessment), ePro (Electronic Patient-Reported Outcome), biosensors, and wearables to monitor their patient’s vitals throughout the study.

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4. Patient Follow-up 

Decentralized Clinical Trials provide participants the liberty to seek medical guidance and treatment within the comfort of their homes, unlike Traditional Clinical Trials, where patients have to schedule an appointment with their doctor and visit the clinic for their periodic follow-ups and checkups. 

DCTs use mobile applications for monitoring the patient's health and HIPAA-compliant telehealth platforms for online check-ups. Besides, patients enrolled in Decentralized Clinical Trials do not have to visit the study site for physical tests. Authorized lab personnel perform these tests in their homes and then upload the results online for further review. 

Digitalizing all the processes of Decentralized Clinical Trials have made it so straightforward and convenient for patients to participate in these studies since they no longer need to disrupt their daily schedules to visit the study sites for checkups or tests. 

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5. End of Study 

At the end of the clinical trial, the participants are asked to ship the equipment that was provided to them to the study site, and compensation is then released into their registered bank accounts. 

The collected data from all the participants is analyzed to create relevant published statistical findings, not to mention that the results are used to determine the advancement of the therapy if it is released on the market for use. 

Lastly, Decentralized Clinical Trials are the most viable option for diagnosing new health problems, conditions, cures, and placebos across various diversities of people with different genetics and geographical locations. DCTs not only allow diverse enrollment rates and higher patient retention rates due to the convenience but also provide better, more accurate results at a relatively reasonable cost compared to Traditional Clinical Trials. 

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Final Words

Although Pfizer conducted the first Decentralized Clinical Trial in 2011, DCTs experienced a significant rise in popularity during the pandemic when people across the world were forced to remain confined in their houses for months at a stretch. A significant drop of 50% in inpatient turn-out for Traditional Clinical Trials back in January 2020 birthed the instant need for Decentralized Clinical Trials. 

Today, due to the global adaptation of virtual medicine and diagnosis, Decentralized Clinical Trials are steadily becoming the primary option for conducting health trials. 

Mahalo Health is a digital platform company that is on a mission to accelerate digital health innovation and aid Decentralized Clinical Trials and healthcare enterprises in implementing the latest technologies for enhanced patient outcomes and ease with their digital health products and services.  We help companies add connectivity to their medical health devices and provide personalized remote patient care platforms and telehealth applications to guide patients toward better care. 

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