Technologies Driving Clinical Trial Management

Clinical trial duration increased by 25% and clinical trial procedures by 58% between 2000 and 2018. Furthermore, the average cost to bring a drug to market, is about $2.6 billion. Frost & Sullivan’s health care analysts have identified the following companies as contributors to advances in clinical trial management technology that may reduce both time and money.

Frost & Sullivan’s Transformational Health business unit tracks technology’s impact in clinical trial management to address trial complexities, harmonize clinical data across sites and manage costs and failure rates. Its independent research indicates that the clinical trial success rate, measured by the overall likelihood of approval of developmental candidates, is only 12%. Clinical trial duration has increased by 25% and clinical trial procedures by 58% between 2000 and 2018. Furthermore, costs are escalating: according to statistics from the Tufts Center for the Study of Drug Development, the average cost to bring a drug to market, including development costs, is about $2.6 billion.

Integration of digital technologies, such as cloud computing, artificial intelligence, Big Data predictive and prescriptive analytics, the Internet of Medical Things and mobile technology, can improve efficiency and accelerate clinical trial processes. Pharmaceutical companies are embracing these technologies to improve patient engagement and reduce trial failures to make drug development more profitable. Innovative business models using virtual technology, wearables and bring your own device have taken clinical trial management to the next level.

Frost & Sullivan’s health care analysts have identified the following companies as contributors to advances in clinical trial management technology.

Science 37 (Playa Vista, Calif.)

Science 37 focuses on siteless clinical trials—direct-to-patient studies—by leveraging cloud computing and telehealth to collect evidence on a therapy. The company uses telemedicine and decentralized physician networks to design an integrated clinical study where real-time patient data is collected to shape outcomes. Its cloud-based mobile research platform, the Network Oriented Research Assistant (NORA), manages clinical trials across all stages—screening, recruiting, remote monitoring and data collection. The company is able to address pain points such as adding diversity by widening the patient pool through remote monitoring. By continuously engaging with trial participants using a variety of communication channels and doing it at a time and place convenient to the patient, they were able to improve patient retention through the end of a study. Leading biopharmaceutical companies such as UCB, Otsuka Pharmaceuticals and Novartis are working with Science 37 to accelerate clinical trials by bringing new drugs to patients in a shorter time. Novartis, for example, in a partnership announced in March, plans to use the platform for U.S. trials in neuroscience, oncology and dermatology that will begin this year. (La Jolla, Calif.) uses artificial intelligence to disrupt traditional clinical trial management processes. Its platform is a combination of important electronic data capture, clinical trial management system and electronic patient-reported outcome functionalities, analytics and adverse event reporting. It accelerates the trial process by directing users through protocols throughout the clinical study and managing informed consent for patient visits and follow-ups. Using deep learning, it collects genomics data and other information from various sources, including past clinical trials and journal articles, to improve study design. The platform also ensures protocol adherence and provides life sciences companies with real-time health analytics using a dashboard to track performance criteria such as general site performance and retention statistics. Established industry players and treatment centers including UC San Diego Moores Cancer Center, Northwell Health, DNX Biopharmaceuticals and Zelegent are using the platform.

AiCure (New York)

AiCure has an artificial intelligence-based mobile platform that Frost & Sullivan identified as having the potential to revolutionize patient engagement and compliance during clinical trials. AiCure’s solution can directly confirm medication ingestion and patient behavior with patented and HIPAA-compliant facial recognition and motion-sensing software that requires no self-reporting or human review or supervision. The AI-backed mobile app uses a device’s camera to process images of the patient taking medicine at the appointed time, and the platform uses predictive analytics and deep-learning methodologies to analyze medication data with an accuracy of up to 90%. This method of direct observation provides actionable insights to physicians to ensure patient adherence to the treatment regimen, especially for clinical trials for mental health and highly infectious diseases. Its advanced security features can determine non-adherent behavior such as concealing a medication in the mouth or spitting out medicine. AiCure’s suite of solutions has U.S. Food and Drug Administration registration as a 510(k) Class 1 exempt device, which allows for marketing and distribution in the United States.

The Road Ahead

Frost & Sullivan research confirms a growing demand for digital health and IT solutions for clinical trial management: the global clinical IT solutions market is expected to be valued at $4 billion by 2020. The requirement for clinical validation of interventions using real-time data and the need to include patient perspectives in understanding outcomes will lead to the development of digital therapeutics, medical adherence and compliance management solutions. The growth in virtual and siteless trials in the next few years will require biopharmaceutical companies to collaborate with technology solution vendors to utilize the benefits of cloud computing, artificial intelligence, blockchain and mobile technology for collecting real-world evidence. This will increase the demand for advanced data integration and analytics solutions to collect, share and compare data from a variety of sources.

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