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Revolutionizing the Clinical Trial Process

Revolutionizing the Clinical Trial Process
September 18 2020

Since COVID-19 emerged in January 2020, it has caused unprecedented disruption of clinical trials and ongoing patient care. Around 1,000 organizations have reported trial disruption. 

To protect patient safety and trial integrity, the pharmaceutical industry made strides to accelerate trial innovations such as digital tools and virtualization, with support from regulatory guidelines. 

COVID-19 altered the conduct of ongoing trials, the biggest change is telehealth in the clinical trial stage. 57% of the clinical trial patient interactions and 79% of the clinical trial interactions between sponsors and contract research organizations taking place remotely. As in-person trial visits decreased, both industry and regulators anticipated the risk of resulting data loss. Regulators issued guidance on statistical mitigation approaches, while sponsors applied telemedicine to monitor patients to replace in-person assessments and limit data gaps.

There are indications that such innovation adoption could be lasting. Clinical trial providers expected remote patient and sponsor–CRO interactions to persist at higher levels than pre-crisis. Among them, 46–78% expected the adoption of digital patient engagement technologies to increase post-crisis. As patient engagement norms change, 34–52% expected trial decentralization approaches such as new site models, online recruitment, home nursing, and direct-to-patient trial supply to increase.

The challenges that COVID-19 poses to running clinical trials may persist until effective vaccines become widely available, and approaches used to address them are expected to become more widely used once the crisis is over. But the lessons learned in innovating the COVID vaccine are certainly valuable and could be pivoted to the clinical trial process to accelerate sciences.  

 

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Starts that Are Accelerating the Clinical Trial Processes :

Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. The company's platform enables cancer researchers and care providers to learn from the experience of every patient. It has built a new patient matching engine within OncoTrials, allowing us to more scalably improve screening workflows.

Mednet is a leading healthcare technology company specializing in eClinical solutions designed for the global life sciences community.
It has two decades of experience and more than 1,200 studies with both CROs and life sciences sponsors. Mednet is a comprehensive, cloud-based, all-in-one eClinical platform incorporating data management, data capture, and trial management tools. 

Syapse is a real-world evidence company working in partnership with health systems, life sciences companies, and regulators to solve the challenges of precision medicine and drive better outcomes for people with cancer around the world. It has a web-based tool for exploring shared, de-identified real-world data that enables study feasibility assessments, identification of unmet needs, post-market usage characterization, and more.

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