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March 25, 2020updated 12 Jul 2022 11:56am

Trial delays in the time of Covid-19

By GlobalData Healthcare

Last week, GlobalData released an Analyst Briefing detailing the increase in overall clinical trial delays due to the global shift in focus to the Covid-19 pandemic (Clinical Trial Delays and Covid-19, GDHC2995EI). This same trend is apparent when looking only at company-sponsored trial delays from 1 January 2020 onwards, as shown in the featured image.

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Eli Lilly is cutting clinical trial activity in response to the COVID-19 outbreak, delaying most trial starts and halting enrollment in most ongoing studies. The company plans to carry out study protocols with the subjects who are already enrolled in its trials on a study-by-study basis. Galapagos also recently announced that it is pausing enrollment in some clinical trials, such as filgotinib’s Phase II and Phase III trials for Crohn’s disease, psoriatic arthritis, and uveitis, in order to help protect patient safety. Bristol Myers Squibb has suspended new site activations for ongoing studies and will not initiate any studies involving healthy volunteers or activate any sites globally for new studies until 13 April 2020. ObsEva has put new patient screening and randomisation for the EDELWEISS 2 and EDELWEISS 3 trials, its ongoing Phase III trials of linzagolix for the treatment of pain associated with endometriosis, on voluntary hold due to the impact of the Covid-19 outbreak. Provention Bio paused a Phase III diabetes study out of caution and will provide an updated timeline at a later date. IVERIC bio will delay the initiation of patient enrolment in a second pivotal trial for Zimura (avacincaptad pegol) for the treatment of geographic atrophy secondary to dry age-related macular degeneration.

Last week, the FDA issued guidance for industry, investigators, and institutional review boards conducting clinical trials during the Covid-19 pandemic. Methods that could help keep the research going include virtual visits, phone interviews, self-administration, and remote monitoring. These suggestions could help trials that are being met with subject quarantine and travel limitations, clinical site closures, and interrupted supply chains. However, the upward trend for clinical trial delays is expected to continue moving forward along with a possible shift toward virtual trials.

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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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