View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
May 28, 2020updated 12 Jul 2022 11:48am

Clinical trials disrupted due to Covid-19 slowly resume

By GlobalData Healthcare

With many countries enforcing strict lockdown measures because of the Covid-19 pandemic, many companies have announced that they are experiencing disruptions to their clinical trials for non-Covid-19 indications. Since early March, more than 500 companies have publicly announced disruptions to their planned and ongoing clinical trials in press releases, US Securities and Exchange Commission (SEC) filings, and on social media. Many companies have delayed the initiation of planned trials or withdrawn the trials completely, and others have suspended enrolment in their ongoing trials or terminated the trials altogether. The majority of trial disruptions could be attributed to patient safety measures, strict lockdown requirements, social distancing procedures, and the high demand on medical professionals to treat Covid-19 patients. As lockdown measures in several countries are beginning to ease, a number of trials are beginning to slowly resume normal functioning.

Free Case Study
img

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.

The COVID-19 Dashboard on GlobalData’s Pharma Intelligence Center dynamically tracks both these disrupted trials and trials that have resumed activity. Over 130 trials are currently resuming, and more trials are being added to this category daily. According to GlobalData’s Clinical Trials Database, 77.0% of these trials are currently ongoing and recruiting participants; 17.0% are ongoing, not recruiting; and 3.7% of trials are completed. The US had the highest number of resumed trials by site locations, at 69.1%, followed by France at 12.0%, the UK at 6.8%, Spain at 6.4%, and Germany at 5.5%, as shown in Figure 1.

The main concern with restarting clinical trials is that Covid-19 regulations still exist in many countries, including lockdown measures and social distancing restrictions. In order to combat these obstacles, many sponsors must implement stricter and alternative measures to previous trial guidelines to ensure patient safety. Sponsors must ensure that inperson trials that are beginning to resume have a new set of measures, including frequent Covid-19 testing, increased cleaning of trial sites, making sure there is an availability of personal protective equipment (PPE), and ideally providing participants with suitable transportation methods to and from the trial site. This may have a direct implication on trial cost, as resuming a trial may be more costly to the sponsor due to increased precautionary measures. Companies are reviewing alternative approaches by using remote measures and virtual clinical trials, which aim to bring the study directly to the patient via online data collection and video call progress checks. In the US, the National Institute for Health Research (NIHR) has recently announced that it is setting up an outline for the reboot of non-Covid-19-related trials that were halted due to the pandemic. Efforts to resume these studies will be parallel to ongoing work on urgent public health Covid-19 studies, which will be still treated as high priority.

Related Companies

Free Case Study
img

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.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena