The clinical research industry is the plinth of the pharmaceutical industry, and it needs to be highly dynamic with its drug development programs. Its progress can only be certain if it is free from site-centric limitations. The research outcomes have to maintain accuracy and precision, for there is no room for error. The need for clinical trials that do not become historic because of time lag demands the implementation of decentralization of clinical research trials.
Decentralized clinical trials utilize technology such as telemedicine, wearable devices, and decentralized apps to conduct clinical research remotely, irrespective of geographical boundaries. These trials expedite the research study and its associated processes by doing away with the necessity of monitoring or administering to patients/participants on-site.
Observation of effects, quality of life of a patient, or any adverse events that might occur due to an administration can be done quickly without a costly delay. This makes clinical trials more accessible, convenient, and cost-effective. Digital tools that include software and hardware facilitate decentralized clinical trials in collecting data from a larger and more diverse patient population while reducing the risk of data loss or breaches. This innovative approach to clinical trials has the potential to speed up the development of new treatments and therapies and increase patient engagement and satisfaction.
The Healthcare industry is a highly sensitive and regulated industry where a tiny error of judgment or a slight delay could end up in an irreversible fiasco. Therefore,
Decentralized clinical trials (DCTs), despite having made things increasingly speedy by offering several benefits over traditional, on-site clinical trials, such as increased patient access and reduced costs, have pitfalls that need to be carefully watched and rectified. The limitations include the following:
DCTs rely on technology, and it uses electronic devices and cloud-based apps that need robust internet connectivity. But the Internet is beset by inevitable downtime and connectivity issues that can become a massive deterrent for patients and clinicians in their aim for quick access to help or data. Lack of standardization across devices and limited user familiarity with technology often result in patient or erroneous data loss. This compromises the quality and integrity of data and disrupts and delays the progress of an otherwise smooth flow of trial management processes.
DCTs may only be a somewhat acceptable solution for some populations and all clinical trials. Some patients may not be comfortable with taking treatments remotely and insist on seeing the practitioner in person. This is particularly true for elderly patients or first-timers who have difficulty navigating technology and administering self-assessments.
The Decentralization of clinical trials has to adhere to several regulations. Any new process must first be approved by a regulatory body, which becomes a challenge as it gets caught up in the complications of approvals. The regulatory body must follow guidelines that must be formulated as and when new processes evolve. Trial sponsors and CROs can only implement their findings and procedures post-approval, consequently resulting in hampering delays.
Decentralized clinical trials have been readily accepted as a preventive for stalling research during the pandemic. Decentralized tools like mobile phlebotomy and telemedicine have been quickly accepted and implemented, but there could be instances and times when an oversight can occur and compromise data quality. For example, a phlebotomist collecting blood samples from the patient’s home could forget to confirm whether the patient has fasted or not, and he could even fail to record or document the time of taking the blood sample.
Despite these limitations, DCTs can potentially increase patient accessibility, reduce costs, and improve the efficiency of clinical trials.
Since site-less clinical trials afford a convenience incomparable for both patients and trial personnel, it is more reasonable to work at mitigating the problems faced by these trials. DCTs rely on self-reported data from patients, which can be subject to bias and inaccuracies. By using objective measures, such as wearable devices to track patient activity, and by implementing strict data collection and verification protocols, these can be avoided.
A robust technology infrastructure to support remote data collection, communication with trial participants, and the secure transfer of sensitive data is the first and foremost requirement of DCTs. This can be addressed by working with experienced technology partners and investing in reliable systems and infrastructure.
Keeping patients engaged and motivated throughout a virtual trial can be challenging, particularly if they are not used to the technology. This can be overcome by providing clear instructions, offering support and encouragement, and incorporating interactive and engaging elements into the trial design.
DCTs raise a number of regulatory and ethical considerations, such as the protection of patient data, the need for informed consent, and the risks associated with remote data collection. These can be addressed by following established guidelines and regulations and working closely with regulatory authorities.
DCTs require willing and compliant participants to reach the trial group's desired sample size. Digital channels can be addressed using social media platforms to attract and enroll potential participants.
Technological advancements and interventions now and in the time to come have the potential to iron out the limitations of decentralized clinical trials and bring medical innovations and inventions to market that, in turn, will increase human longevity.
Despite limitations, DCTs have the potential to increase patient accessibility, reduce costs, and improve the efficiency of clinical trials. Healthcare technology plays a crucial role in overcoming the deterring challenges of clinical trials. With technological interventions, the barriers to a successful and logical conclusion to a clinical trial can be set aside.
Medical technology and interoperability have helped considerably in reaching out to a larger pool of potential participants and streamlining the recruitment process. For example, online patient communities and social media platforms are hugely useful in advertising clinical trials and increasing awareness among patients.
Technology innovation has successfully helped improve data collection and process management accuracy and efficiency in clinical trials. Electronic data capture (EDC) systems and mobile health (mHealth) technologies are being used to collect real-time data from patients, reducing the risk of errors, increasing the speed of data collection, and bringing down the reaction time for medical help.
mHealth technologies and wearable devices have encouraged patient engagement and compliance in clinical trials. Mobile apps that have been created for monitoring and recording the health data of a patient have facilitated in making healthcare services patient-centric. This helps in retaining participants and improving their quality of life post-treatment. For example, wearable devices track patient activity and monitor their vital signs, while mobile apps provide patients with reminders and educational materials to help them faithfully adhere to their treatment plans. A trial design that is interactive and supportive could be of great help to patients who are not very forthcoming.
With the help of technology, clinical trials utilize telemedicine and other software tools to engage patients and participants who are remotely situated. This mode of trial research has reduced the need for in-person visits and has increased patient convenience and comfort. Remote monitoring further facilitates improving the accuracy of data collection by using patient-reported outcomes, which works for continuous monitoring of patients outside of the clinic.
The use of advanced analytics tools helps in extracting insights from large and complex data sets that are generated during clinical trials. Machine learning algorithms identify patterns and trends in data, while researchers use data visualization tools to communicate their findings more effectively.
Decentralized clinical trials are being given a fillip by several technologies that circumvent glitches and pitfalls. These technological innovations include patient-centric technology platforms, easy web access, trial updates, alerts, etc. There has been a recent rise in the number of technology and SaaS products aimed at improving the efficiency and effectiveness of decentralized clinical trials (DCTs). Some of the latest technologies and products that are helping with DCTs include:
Sponsors of DCTs are faced with problems related to reproducibility, data sharing, personal privacy concerns, and patient enrolment. Blockchain, a relatively new technology, can be a key to solving this problem. It allows for tracking, sharing, and managing data within high-security tracking systems that ensure data sharing with utmost transparency and maintenance of privacy concerns of the participants. It provides a secure, decentralized platform for storing and tracking data in real-time. Blockchain can be effectively used to store and manage sensitive patient information, ensuring privacy and data security.
Tools like wearable devices, mobile apps, and telemedicine technology allow patients to participate in clinical trials from the comfort of their own homes, practically doing away with the need for frequent visits to trial sites.
AI and machine learning algorithms can be used to analyze large amounts of patient data, streamlining the data analysis process and providing insights into trial outcomes.
These systems allow patients to provide real-time feedback on their condition, providing a more accurate and up-to-date picture of their health. With ePRO, adverse events can also be taken care of without the patient reaching an irreversible health downturn.
These platforms offer a centralized, secure environment for conducting DCTs, allowing for the management of trial data, communication with patients, and the tracking of trial progress.
Some examples of SaaS products in this space include Mahalo Health, Medable, Parexel, and TrialSpark. SaaS platforms make clinical research patient-centered within an environment that gives rise to a need for global remote access and quick speedy results across a large volume of patients/participants. It facilitates reliance on patient-reported outcomes and reduces the operational complexity of the trial, ultimately resulting in gratifying patient experience and an expedited outcome delivery.
Mahalo Health transforms Decentralized Clinical Trials (DCTs) with its cutting-edge platform. Simplifying remote data collection, virtual monitoring, and patient engagement, it expedites enrollment, enhances trial efficiency, and fosters patient-centricity. Real-time analytics offer valuable insights, while robust data management ensures compliance. The result: streamlined DCTs, reduced costs, and accelerated medical advancements.
Clinpal is another leading SaaS product that allows researchers to manage remote trials with patient-centric digital platforms and end-to-end solutions for enrolment, consent, engagement, and data capture.
Science 37's NORA (Network Oriented Research Assistant) is another trailblazer that can revamp DCTs, offering a comprehensive platform for seamlessly integrating telemedicine, mobile nursing, and connected devices for remote trials. It has been designed to optimize participant recruitment, retention, and compliance.
Similarly, Medable's platform, with its patient-facing app and TeleVisit feature, facilitates seamless communication, virtual visits, and electronic consent.
Moving into uncharted territory, Veeva Systems presents a cloud-based SaaS solution for electronic data capture (EDC), providing unified clinical data management systems to ensure efficient trial execution. Their software offers functionalities such as protocol design, data cleaning, and comprehensive reporting.
Decentralized trials are also fueled by the ObvioHealth platform, an innovative SaaS product combining an app and dashboard for real-time data collection, patient monitoring, and efficient trial management.
Covance's Xcellerate suite takes it further with its integrative technology that streamlines the entire trial process from patient recruitment to risk-based monitoring, thus improving data quality and reducing costs.
Signant Health’s TrialMax® platform provides eCOA (electronic Clinical Outcome Assessments) solutions, engaging patients and ensuring accurate data collection.
These SaaS products underscore the progressive shift towards decentralized clinical trials, leveraging technology to expedite research and improve patient experiences while ensuring data integrity. There is a further appreciation for Saas products and technologies supporting DCTs, post Covid-19 as pharmaceutical companies raced against time to create vaccines and palliatives for the pandemic-affected human race. For biopharmaceutical and medical device sponsors, CROs, SaaS products, and technologies supporting DCTs come with the added advantage of flexible pricing, i.e., they offer a modular trial-fit subscription model with pay-per-module-user pricing.
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