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FDA guidance (March 2020 and updated July 2020) acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits or put new processes in place regarding their current protocols.
Since COVID 19 has changed many of our normal way to conduct Clinical research, most organizations reported some level of impact on ongoing trials due to COVID-19. Indeed, only 8% of the organizations reported low or no impact , while 44% experienced high impact.
To overcome the impact on the ongoing clinical trials, organizations look into adoption of technologies for remote monitoring and patient-centric and decentralizing approaches.
- Remote technologies involved: telemedicine, eConsent, ePRO, EMR/data integration and wearable.
- Patient-centricity approaches involved: home health, decentralized laboratories and direct to patient drug delivery.
Moving forward, it is reasonable to predict that the COVID 19 clinical trial experience would permanently accelerate use of remote technologies in clinical trials. Additionally, we may aim to streamline the data collected from trial protocols, seeking to provide greater flexibility to investigators and removing “nice-to-have” outcome measures from protocols.
Meanwhile, high upfront investment cost and unclear regulatory stance drove several interviewees to predict that trials would return to “normal” post-COVID-19. This perspective may not be applicable to oncology and rare disease clinical trials, where investigators and site personnel believed that in-person care is critical.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.