Clinical trials are crucial for the safe development of drugs. Whilst traditionally trials have been typically carried out in centralized settings, there has recently been a move toward a more decentralized approach. This article will discuss this subject.
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Clinical Trials – An Overview
Clinical trials are an important step in the research and development of new drugs before they are released onto the market. From the initial idea to the completion of the trial and approval of the drug, several steps need to be undertaken. There are many different types of clinical trials including behavioral, quality of life, screening, and diagnostic trials, each with different purposes.
Initially, the idea for a clinical trial starts in a laboratory setting. Treatments and procedures are tested in the lab and animal models before being approved for human trials. Studies move through a series of steps termed phases, where researchers learn more about the drug or treatment, including its effectiveness and any potential risks to the patient’s health.
Clinical trials have criteria that inform which groups of patients will join them (such as adults, children, patients, healthy volunteers, and people from diverse age, ethnic, and racial backgrounds) and there are a series of protocols that govern how a trial will be carried out. Protocols include the goals of the study, eligibility requirements, information that will be gathered, the expected duration of a trial, risks to participants and protections to put in place, and details about treatments and tests.
Not all clinical trials follow the same design and different types of trials exist. However, many trials include standard design elements. Randomization is one design element where patients are randomly assigned a treatment rather than being selected for a particular treatment. This avoids bias. Blind and masked studies are used to improve the accuracy of collected data, as participants and researchers are prevented from influencing the study results. These can be single-blind or double-blind tests.
Once the study is complete, data is analyzed to inform the further development of the treatment. There are four phases of clinical trials, with Phase I trials being tested on a small group of people. Trials progress up to Phase IV, where medicine is approved for public use and its safety is tracked within the population.
Centralized Trials and the COVID-19 Pandemic.
Traditionally, clinical trials have been carried out in a centralized setting, where volunteers are monitored in a controlled environment by researchers. Studies can be carried out across multiple sites. Centralized monitoring can be employed to streamline the process and analyze data from multiple sites, bringing advantages to trials.
However, the COVID-19 pandemic has thrown the proverbial spanner in the works. Many trials have had to be paused or scaled back, which has disrupted the development of several new drugs and therapeutics. This is an untallied cost of the pandemic in terms of quality of life and lives lost.
Another trend that has emerged during the pandemic is the rapid adoption of technologies that aid remote interaction. Aside from the much-lauded benefits of remote working, this trend has shown potential for connecting patients and physicians virtually. Telemedicine has been swiftly adopted worldwide. This virtual approach can confer benefits for clinical trials, decentralizing them and helping them adapt to the so-called “new normal.”
Is Decentralization the Future?
The move toward a more decentralized, virtual approach to medical care has coincided with the development of technologies that facilitate this trend. Video conferencing, improved internet connectivity, connected and wearable medical devices, smartphone-based applications, and electronic medical records have all been introduced. Interest in decentralized clinical trials has gone hand-in-hand with the adoption of virtual and remote medicine.
Decentralized trials are less dependent on traditional research facilities and specialist intermediaries for data collection. These types of trials leverage new technologies such as sensory-based technologies, telemedicine, and wearable medical devices. Home visits, direct delivery of materials and treatments to the homes of trial participants, and patient-driven virtual health care interfaces have been increasingly adopted by trials.
Currently, many trials already incorporate decentralized elements in their design. Decentralized trials often include traditional design elements with decentralization of patient/subject interaction. Fully decentralized trials involve no in-person contact between patient and researcher. Data fed back from the decentralized trial is analyzed remotely by researchers to inform the future direction of drug development.
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Advantages of Decentralized Trials
There are further advantages to decentralized trials. Due to the need for less infrastructure, decentralized trials can confer cost savings for researchers and institutions. Logistics of trials can be improved by improving subject and patient recruitment and retention. Patients who would otherwise face challenges with centralized trials find it easier to enroll in decentralized ones. Participation obstacles such as accessing trial locations can be overcome.
Trial access for under-represented populations can be improved, for example, elderly populations, those living in rural areas with fewer transport links, and certain ethnic minorities. Participants do not have to worry about their work commitments and getting time off for clinical trials. The generalization of results across diverse populations can be improved.
Additionally, individualized thresholds for measuring the effects of treatments can be established which decreases the trial sample size. Technologies such as biometric sensors can improve objective data collection on factors such as pain, cognitive function, quality of life, and functional status. Individual responses to treatment can be better understood. Study safety can be improved.
Moreover, because there are fewer centralized sites, institutional review boards and redundant applications are decreased, significantly saving on cost and site-specific inconsistencies. Less research staff are needed as well, as many processes can be carried out virtually. Overall, decentralized trials reduce cost, errors in reporting, and trials have the potential to be quicker and smaller.
The Future
Decentralized trials have numerous potential advantages over traditional, centralized clinical trials. As trends in remote connectivity and virtual working increase, clinical trials can benefit from this shift and new technologies. Decentralization may be the future of clinical research.
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