A Decentralized clinical trial is a medical research field that tests medical interventions, including new drugs and procedures and their efficacy. Such trials are the lifeline of medical advances, helping biotechnology professionals develop treatments to improve the quality of life or extend survival rates for life-threatening diagnoses.
The clinical trial industry is constantly evolving to improve benefits to all parties, and decentralized clinical trials (DCTs) are the latest development yet in the industry.
DCTs are medicine’s version of digital migration, facilitating remote trial protocols through strategic partnerships with tech giants like Hexaware.
Below is an overview of DCTs are here to stay and their future for the clinical trial industry.
1. Offer Better Participant Experience
Before the advent of DCTs, the clinical trial industry adopted site-focused protocols. Site-focused protocols mean clinical trial participants must be physically available at designated trial centers, medical universities and colleges, hospitals, and community clinics.
While site-focused clinical trial protocols remain integral to the clinical trial industry, they present numerous challenges to participants, leading to a high dropout rate.
According to one research review, controlled randomized trials from reviewed medical journals showed at least a 20% dropout rate. Such high dropout rates disrupt the trial’s model and threaten the final results’ integrity.
However, unlike site-focused clinical trial protocols, DCTs are patient-centric, prioritizing participant comfort and convenience. Such patient-centric protocols improve the participant experience significantly, leading to high patient engagement and retention rates.
Patient engagement involves involving the participants in some trial decision-making processes, including design. Its primary advantage is fostering trust between the clinical trial’s participants; health workers involved third parties, and the whole community.
The public trusted that patient engagement helps foster patient retention by inspiring confidence in the community that the clinical trial benefits public health advancement. Additionally, it promotes patient retention, minimizing mid-trial dropout cases due to avoidable circumstances like limited accessibility to target sites.
Decentralized clinical trials that allow participants to enroll, give consent, undergo screening, and receive follow-ups can only do so through remote data monitoring solutions like Hexaware.
Additionally, while some clinical trial elements may be conducted remotely, others require in-person participant availability. Hexaware helps integrate the remote and site-based research elements through aggregate data centralization technologies, facilitating holistic success.
2. Better Reach Through Accessibility
One of the most significant downsides to site-based clinical trials is limited participant access. Consequently, the data generated from such trials, even with the most comprehensive research design models, tend to be from non-representative samples, limiting the final research’s evidence.
Site-based clinical trials often inadvertently exclude potential participants located geographically far from the site and people with challenged and limited mobility. Additionally, such trials remain inaccessible to underrepresented communities, such as natives, who may lack access to information.
On the other hand, DCTs are more accessible to diverse participants thanks to their digital integration aspect. Contract research organizations (CROs) and pharmaceutical companies work with data technology platforms like Hexaware to enable participants to undergo the screening process through e-consent, telemedicine, and electronic health records.
Additionally, Hexaware’s platform allows participants to engage in remote follow-up sessions, limiting and sometimes eliminating participant burden.
However, one thing worth noting is that accessibility extends to the technology and platforms used to administer and monitor the trial. The technology should be easy for participants to access and have an intuitive interface that is easy for individuals with diverse education and ability levels to use. Hexaware has experience making intuitive apps and platforms for automation in digital medicine.
3. Timely Clinical Trials
Like any research project, clinical trials include a time frame as part of the research design model. However, one study on clinical trial recruitment and retention established that 80% of clinical trials fail to be completed on schedule with delays of at least six months.
According to the study, late enrollments necessitating the establishment of new study sites, and participant safety concerns are the primary reasons for clinical trial delays.
Clinical trials are expensive, even for big pharmaceutical companies; most CROs rely on sponsors to fund the trials. Therefore, the loss of resources due to the on-site research challenges highlighted above can compromise future sponsor-CRO relationships. However, DCTs can overcome time management challenges, preventing financial losses and preserving data integrity.
4. Enhanced Data Accuracy
Data analysis and reporting are crucial clinical trial elements. Site-focused clinical trials primarily use human experts to collect data from the participants. However, despite expert involvement, the data handled by humans are prone to personal biases and errors.
DCTs use information monitoring technology to collect remote data aggregates, organize the data and use analytics features to process the data into information.
Besides bias-free and accurate data collection, digital medical technology devices and software like wearables, apps, and sensors enhance participant engagement, allowing them to submit more data in real-time.
5. Improved Protocols And Research Designs
Digital platforms used in DCTs collect real-time participant data. Additionally, DCT-enabling platforms employ disruptive technologies like analytics and AI to interpret data in real-time.
Such timely data processing allows trial managers to respond to any note-worthy issues reflected in the data. Therefore, DCTs offer unparalleled flexibility in clinical trials.
Decentralized clinical trials are among the most disruptive evolution to hit the clinical trial industry. Although stakeholders need to do more to integrate technology, streamline the trials and establish the cost advantage, the pros of DCTs outweigh its cons.