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September 29, 2021updated 11 Jul 2022 2:47pm

US leads actively recruiting clinical trials for Covid-19

As new strains of COVID-19 continue to drive new cases globally, companies and institutions have continued development of interventions for the virus.

As new strains of COVID-19 continue to drive new cases globally, companies and institutions have continued development of interventions for the virus. For example, the FDA granted full approval to Pfizer/BioNTech’s COVID-19 vaccine Comirnaty for the prevention of the disease in individuals 16 years of age and older on August 23, 2021.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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Currently, there are over 2,000 COVID-19 clinical trials recruiting patients, with 16% being for vaccines and 84% for therapeutics. By geography, the US has the largest percentage of trials at 20.2%, followed by China and India. A further breakdown can be seen in Figure 1. Four of the top five areas for trial recruitments are states within the US (California, Texas, Florida, and New York), this is likely due to the US having the most COVID-19 cases, with the most cases being in California, Texas, Florida, and New York. Running trials in these locations would raise the success rate of completing these trials, an important factor when considering that the top reason for terminated/suspended/withdrawn COVID-19 clinical trials is low accrual rate, at 17%.

As the US lags based on the number of fully vaccinated citizens compared to other countries such as the United Arab Emirates, Portugal, and Spain, it is expected that unvaccinated patients will drive increased rates of COVID-19. As these cases rise, trends show that the number of recruiting trials will follow, solidifying the US as the top area to run COVID-19 clinical trials with the best chance for a successful trial.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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