Over the past few years, the landscape of clinical trials has experienced significant transformations. Traditionally conducted with volunteers in hospitals or pharmaceutical labs, clinical trials faced new challenges due to the Covid-19 pandemic and the need for social distancing. The United States has been at the forefront, conducting 157,618 trials from 1999 to 2021. The majority of trials (73%) involved adults, while 13% included children.
The Clinical Trials Landscape in 2022:
Digitalization has emerged as a valuable solution during the pandemic, revolutionizing clinical trials with wearable devices and virtual consultations. These advancements have resulted in cost and time savings for patients, clinicians, and clinical research organizations (CROs). Technological innovations are addressing several challenges in clinical trials:
Patient Convenience and Personalization: Decentralized trials have made participation more convenient for patients, leading to improved recruitment and retention rates. This approach also allows for the generation of real-world evidence, enhancing the value of clinical trials. Customized trials with extensive data and real-time availability are the future, empowering patients with mobile applications to access and understand their own health data. This transparency fosters trust and credibility in the trial results.
Cost Reduction for Sponsors: High costs have been a pressing concern for CROs and pharmaceutical companies. The decentralized model has the potential to minimize expenses and streamline processes, ultimately reducing costs and saving time.
Enhanced Data Quality: Artificial intelligence and improved data quality measures contribute to optimized results, increasing the likelihood of technical success .
Key Clinical Trends in 2022:
The focus of clinical trials in 2022 revolves around two primary areas:
a. Patient-Centric Approach: Prioritizing patient-centricity improves patient recruitment, retention, and overall data quality, resulting in higher-quality trials while minimizing patient burden and trial costs.
b. Reduction of Site Visits: Virtual clinical trials alleviate the need for frequent site visits, enhancing patient satisfaction and reducing associated costs and time commitments.
Furthermore, the combination of in-home and wearable devices enables the collection of real-time, real-world data. Decentralization also facilitates trial recruitment in geographically diverse regions, with an increasing number of trials taking place in Asia, Eastern Europe, Central America, and South America.
Major Challenges in Current Clinical Trials:
Data Collection: Despite technological advancements, collecting and organizing data in the appropriate manner remains a significant challenge. Big data analytics offers a solution by securely storing and rapidly retrieving vast datasets. Machine learning algorithms help harness this variable and unstructured data, providing critical clinical insights on safety, efficacy, and tolerability.
Real-Time Monitoring Devices: Virtual trials introduce the need for accurate patient tracking within their homes. Monitoring clinical vitals, drug reactions, and medication adherence are crucial for assessing efficacy and safety. In-home devices, wearables, and mobile apps enable trialists and clinical trial companies to monitor patients remotely, ensuring the smooth operation of virtual trials .
Patient Data Collection: Each patient possesses unique health vitals, necessitating consideration during clinical trials. Identifying drug side effects and reactions is crucial for evaluating efficacy and safety. Digital technology and algorithms offer deeper insights into the effectiveness and risks of new drugs, ultimately reducing risks for future patients.
The clinical trial landscape is swiftly shifting from centralized and labor-intensive trials to decentralized patient-centered trials. This transformation holds great potential for improving the patient experience, increasing the likelihood of trial success, and reducing costs and time requirements. With the aid of cutting-edge technologies, such as big data analytics, artificial intelligence/machine learning, and real-time monitoring, clinical trialists and pharmaceutical companies are embracing innovative approaches like virtual trials. Coherence Health offers comprehensive solutions for decentralized and virtual trials, prioritizing a patient-centered approach. Addressing the unique requirements of each trial, Coherence Health delivers hassle-free solutions for both patients and trial organizers.