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June 2, 2021updated 12 Jul 2022 11:13am

Resumed trials continue to increase despite vaccine concerns

Since early March 2020, more than 500 companies have publicly announced disruptions to their planned and ongoing clinical trials due to the COVID-19 pandemic. Many companies have delayed the initiation of planned trials or withdrawn them completely, and others have suspended enrollment in their ongoing trials or terminated the trials altogether.

By GlobalData Healthcare

Since early March 2020, more than 500 companies have publicly announced disruptions to their planned and ongoing clinical trials due to the COVID-19 pandemic. Many companies have delayed the initiation of planned trials or withdrawn them completely, and others have suspended enrollment in their ongoing trials or terminated the trials altogether. The majority of trial disruptions can be attributed to patient safety measures, strict lockdown requirements, social distancing procedures, and the high demand on medical professionals to treat COVID-19 patients.

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As the initial peak of the virus started declining, many trials were set to resume activity. However, the number of confirmed COVID-19 cases is increasing again, especially in India where numbers are skyrocketing.

The COVID-19 Dashboard on GlobalData’s Pharma Intelligence Center dynamically tracks both disrupted and resumed trials.

As of May 17, the number of resumed trials is currently at 1,039. Out of these trials, 60.7% are currently recruiting participants, 17.6% have completed recruitment but are still ongoing, and 0.2% have yet to start recruiting subjects. The figure below shows that there is a very slight, steady increase in trials resuming activity. Initially, the general trend showed a gradual increase in the overall percentage of trials for each trial status, the biggest of which has been seen in ongoing, recruiting trials and ongoing, not recruiting trials.

The US has the highest number of resumed trials at 69.6%, followed by the UK at 9.1%, Spain at 7.4%, France at 7.2%, and Germany at 6.8%. With the global rollout of COVID-19 vaccines from companies such as Pfizer, Oxford/AstraZeneca, and Moderna, the global figures are declining. However, concerns have been raised about the adverse effects of the Oxford/AstraZeneca and Johnson & Johnson vaccines, with a small number of individuals affected by blood clots.

India is currently experiencing an increased number of cases and deaths. With oxygen shortages and a lack of hospital beds, it is expected that international aid will boost the vaccine rollout in India in addition to providing needed medical equipment.

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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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