Traditionally, clinical trials were conducted in hospitals, clinics, and universities, requiring the participants to visit the trial center physically to both enroll in the study as well as to submit their data regularly.
During the Pandemic, due to various social restrictions, the trials were conducted online with the help of modern technology. It included online enrollment, remote medicine administration, virtual visits by physicians, and remote data collection using various devices. This paved the way for ‘Decentralised Clinical Trials’ or DCT’s, enabling participants and researchers to conduct the trial remotely.
Decentralized Clinical Trials were necessary amid the Pandemic, but due to their high success rate and increased efficiency, researchers continue to opt for post-pandemic DCTs.
Conventional Clinical Trials (CCTs) are the reason behind today’s research advancements from medical biology to pharmaceutical advances. However, CCTs came with several drawbacks, making them less efficient over the modern DCTs.
Absence of a Patient-Oriented Process
Earlier, participants had to find an ongoing clinical study for their ailment, apply to volunteer in the research and wait for the response from the researchers. In most cases, the location where the study was being conducted and where the participant lived never coincided. This resulted in multiple to-and-fros to the research center.
The lengthy process of finding a study is almost always accompanied by a screening process or an eligibility criterion deciding whether the volunteer is fit for the trial. Often, the participants visiting the center were rejected as they needed to pass the eligibility criteria for the study, meaning they were enrolling for the wrong research. This resulted in patients turning their cold backs to clinical trials.
Physical Limitations of the Centers
The research centers conducting studies are not always accessible to the participants. The centers are only sometimes readily available with advanced equipment. Most participants find reaching out to these centers and submitting data burdensome.
The centers need a trained workforce and regulatory authorities to create a good experience for the participants. On the other hand, the unavailability of participants for the study is also a barrier for the researchers, and we will discuss it further in this blog.
Higher Cost of Operations
Conventional clinical trials require a high volume of trained staff to manage the participant’s data collection process and other operations, such as maintaining the equipment for data collection and processing. With high volume comes a high cost of operations.
New offline centers for research and more on-site equipment add to the surging cost of conducting clinical research. Moreover, during the recruitment phase of a trial, the researchers need a marketing campaign for the same, which again increases the cost of conducting a conventional clinical practice.
Demanding Data Collection Techniques
Clinical studies are conducted to collect data, analyze it and devise a solution to the rendering problem. The traditional clinical trials required participants to visit the center twice or thrice every week and at times every day to submit their samples for data collection. Traveling, which is a burden to the participants, the tenuous process of filling out forms, submitting the sample, and maintaining the prerequisites for sample collection overwhelms the participants during a trial.
Moreover, the data collected is usually accompanied by external factors such as physical and mental stress, the irregular time interval between the samples, and the manual task of managing the data. Such factors play an essential role in defining the efficacy of a clinical trial.
Poor Patient Recruitment
Patients are willing to enroll in studies that provide better treatment; still, 86% of the clinical trials fail to register the required number of patients for the study. Even after recruiting patients for an investigation, researchers lose many volunteers due to a low retention rate.
It is complicated for patients to find ongoing trials, especially those relevant to them. After finding a trial comes the screening process and the consent contract for conducting the studies. The location of the research center from the participant’s residence plays a crucial role in determining whether or not the individual will enroll in the study. The post-enrollment inconveniences such as unfriendly coordinators and inadequate staffing may be a reason behind patient dropouts and low retention rates.
Essentially, there are three stakeholders in a clinical trial. The primary stakeholders are the patients and volunteers, the researchers conducting the study, and the investors providing the funds for the research. Decentralized Clinical Trials have proved to be beneficial for all three stakeholders in one way or the other.
Improved Patient Reach
We have already addressed how patient recruitment is crucial in conducting a successful clinical trial. With Decentralisation, participants can enroll for a study over the internet, check the eligibility criterion, and get relevant notifications regarding upcoming studies.
Decentralization helped in extending the accessibility of a study to remote locations, increasing the diversity of participants enrolling for the study.
Ease of Conduct
Decentralized Clinical Trials require less staff for a study and comparatively less equipment, and the process of enrolling to start the study is seamless. The use of telemedicine for administering proper doses of a drug on time, wearables for collecting real-time data, and mobiles & desktops for virtual visits by the physician make clinical trials more efficient.
Better accessibility for different communities to participate in a study has become possible due to the ease of conducting a Decentralised Clinical Trial.
Enhanced Experience
Traditional Clinical Trials are challenging due to their demanding conduct, such as visiting the center, data management, and the possibilities of manipulating the data collected. In a Decentralised Clinical Trial, the patients are provided with 360-degree support from the researcher team and management staff, and are connected to the ecosystem of the study. With DCT, most participants are satisfied with the conduct and feel the process is less exhausting.
Timely notification for medicine and drastically reduced commuting have been the prime advantages of enrolling in a DCT.
Increased Profit Margins
Decentralized clinical trials require less staff to conduct a study. This is due to the virtual assistance and use of tools like telemedicine and mHealth, which reduces the direct burden of assisting patients while collecting patient data in real-time.
Reduced workload and lower operational costs are the benefits of a decentralized clinical trial. Having a decentralized trial also diminishes the need for highly extravagant infrastructure. However, only the necessary equipment is to operate smoothly. These factors will account for increased profit margins in a decentralized trial.
Decentralization has its perks over conventional methods of conducting a clinical trial. DCTs have increased efficiency over the traditional ones, more accurate data collection, and benefits to all the stakeholders in the study.
Decentralization will continue to make clinical trials more available as they have made it easier for patients to become a part of clinical trials without over-exerting themselves and finding a relevant trial for them in the first place. The unparalleled benefits and experience have made decentralized clinical trials a need of the hour.