During covid, people worldwide saw a more significant shift from offline to online mode. All the world went into lockdown and had to give the traditional ways to work. From January 2020 to April 2020, there was a 50% decrease in the monthly trial starts, and in May 2020, 60% of the investigators reported a marked decline in trial activities. The clinical trial field, too, needed to update, but the main issue they faced was monitoring clinical trials. So, the researchers came up with a few ways, such as decentralized, virtual, hybrid, or remote clinical trials, to continue the clinical trials even during a pandemic or any other calamity. With the introduction of decentralized, virtual, hybrid, and remote clinical trials, the medical research field has seen a paradigm shift that facilitates more inclusive and patient-centric approaches. As the field continues to evolve, these innovative trials design have shown the potential to revolutionize the ways of evaluation of medical devices and treatments is being done, ensuring safer and more effective healthcare interventions for the benefit of patients worldwide.
Description:
Medical devices undergo clinical testing before the targeted population can use them. Clinical testing aims to test the medical device on the human population to decide the safety and efficacy. Medical device companies must conduct preclinical testing and research on their product before applying for a clinical trial because clinical trials involve human participants. Preclinical activities, including actions like the following, ascertain whether a device is safe and effective enough for human subjects.
Bench test
Technical evaluation
Simulations on a computer
Animal research
The manufacturer must first obtain approval for their proposed investigation before they can begin clinical trials with their device. The procedures for obtaining approval and starting a clinical trial vary depending on the country.
The clinical trial of the medical device requires continuous monitoring, which can be done in one of the four ways given below:
Decentralized clinical trials.
Virtual clinical trials
Hybrid clinical trials
Remote clinical trials
Why do we need so many new types of clinical designs?
There are lots of difficulties in the traditional type of clinical trials; thus, the push for virtual, hybrid, decentralized, and remote clinical trials results was needed for a variety of reasons, including the following:
Reaching patient populations who don't live close to existing study centers can be challenging.
Clinical research costs are soaring (many of them due to site costs).
Despite the availability of new technology, manual data collection.
High discontinuation and/or early termination rates due to perceived burden.
In this article, we will explore the differences and similarities in the clinical trial study design types in detail.
Parameters | Decentralized clinical trials (DCTs) | Virtual clinical trials (VCTs) | Remote clinical trials (RCTs) | Hybrid clinical trials (HCTs) |
Definition | Studies that are "executed through telemedicine and mobile/local healthcare providers, using processes and technologies different from the traditional clinical trial mode" are known as (DCTs). | Virtual clinical trials sometimes used interchangeably with decentralized trials, are designed to run predominantly through remote data collection and patient engagement methods. | Remote clinical trials typically refer to trials where participants primarily or exclusively interact with the study remotely. Remote clinical trials often fall under the broader categories of decentralized or virtual trials. | A hybrid clinical trial combines the aspects of conventional traditional clinical trials with remote, virtual components that are delivered online or through a mobile device. |
Use of technology | Relies heavily on health technologies, wearables, and telemedicine platforms. | Relies heavily on health technologies, wearables, telemedicine platforms, and in-person data collection methods. | ||
Selection of patient | Patient selection can be widened. Patients far from the study site can also be included, and the study population can diversify. | Patient selection can be widened as patients far from the study site, and those who stay near the study center can also be included. It makes the study population can become diversified. | ||
Data collection | They can enroll, obtain consent form, monitor, and collect patient data at home using digital tools. They can also send ambulatory care teams for infusions and tests and tell participants to visit local facilities or central labs. | The patient can be enrolled using digital tools to obtain consent form, monitor, and collect patient data at home but can travel if needed. | ||
Pre-screening | Basic eligibility is assessed using a questionnaire used for pre-screening. Before approving the study's participants electronically, those who qualify are given a general overview. The patient can access a questionnaire covering every research eligibility aspect after signing the consent electronically. | With pre-screening surveys, they can guarantee eligibility, broaden the participant pool, and lessen the workload for both the site and the participants. | ||
Product Distribution | It can be shipped directly to the patient’s home. | They can be sent directly to patients’ homes, or they can collect from the study center. | ||
The biggest challenges in Decentralized, Virtual, Hybrid, and Remote clinical trials are:
The protocols of Decentralized, Virtual, Hybrid, and Remote clinical trials components need to be sufficiently explained and justified.
Communication of safety information becomes the responsibility of the participants.
Inability to determine a participant's suitability and eligibility effectively.
Interpreting large datasets can be challenging.
Limited evaluation of digital outcome metrics.
Tracking the data
Integration of new technologies
Keeping track of the patients
Conclusion: Over the past few years, medical research has shifted towards decentralized, virtual, hybrid, and remote clinical trials. There has been a significant advancement in the field of medical research. These innovative trial designs have emerged as effective solutions to overcome challenges faced by traditional clinical trials, particularly during the COVID-19 pandemic. They offer numerous benefits, including increased accessibility to a more diverse patient population, reduced costs, and the integration of modern technology for remote data collection and patient engagement. While these new clinical trial designs present exciting opportunities, challenges exist, including more precise protocols, effective communication of safety information, and the interpretation of large datasets. However, ongoing technological advancements and increased experience with these approaches will likely address these challenges and further optimize the efficiency and effectiveness of clinical trials.
