View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
April 9, 2020updated 12 Jul 2022 11:56am

Disruption of Clinical Trial Progress in Oncology by the COVID-19 Pandemic

Country-wide lockdowns as a countermeasure against COVID-19 have severely affected the clinical development of new agents. Pharmaceutical companies and academic institutions have chosen to de-prioritize and suspend certain clinical trials or to defer enrollment to a later date.

By GlobalData Healthcare

Country-wide lockdowns as a countermeasure against COVID-19 have severely affected the clinical development of new agents. Pharmaceutical companies and academic institutions have chosen to de-prioritize and suspend certain clinical trials or to defer enrollment to a later date. In mid-cap to large-cap companies, a halt in trial enrollment has been decided on a case-by-case basis, but in small-cap companies, it can be across the board, due to their small number of ongoing clinical trials.

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.

Academic institutions/hospitals may choose to halt all trial enrollment not only to minimize the risk of transmission for the trial participants but also to shift key medical personnel to treating COVID-19 instances. The pharmaceutical industry may choose to move resources away from other therapy areas and into new, high-priority clinical trials for anti-COVID-19 agents and vaccines. Thus, multiple therapy areas can be simultaneously affected at various degrees. Oncology is a therapeutic area that is particularly susceptible to disruption from COVID-19. Patients with cancer typically have increased risk of all infections, especially after treatment with toxic chemotherapy, stem cell transplants, or surgery.

While it is difficult to monitor the effect of the pandemic on clinical trials in real time, a new proprietary dataset of GlobalData, updated daily, allows investigation into disrupted trials across indications. Specifically, clinical trials that are delayed, suspended, or otherwise affected by the COVID-19 pandemic are aggregated daily and as of 8 April totaled 389 trials. A breakdown by therapy area shows that the greatest proportion of disrupted clinical trials concern clinical development in oncology (28%), followed by the central nervous system and gastrointestinal clinical development areas at 14% and 8%, respectively. Most instances of administration of injectable anti-cancer agents are performed in the inpatient setting. Trial investigators may hesitate to bring cancer trial participants as inpatients, due to the increased risk of exposure to COVID-19 within hospitals. Rather, they may choose to move these patients to an outpatient setting when possible, or delay treatment, thus disrupting the trial protocol. Within oncology, an indication breakdown shows that five tumor types are responsible for more than 50% of disrupted trials: lung cancer (15.6%), breast cancer (11.9%), multiple myeloma (8.3%), myelodysplastic syndrome (8.3%), and prostate cancer (8.3%).

Interestingly, 66% of all non-oncology, COVID-19-disrupted trials are sponsored by the industry, compared to 51% of oncology trials. The existence of large, cancer-focused academic institutions that serve as single clinical trial sites may contribute to this difference. Specifically, sites such as the Fred Hutchinson Cancer Research Center and the Centre Leon Berard are behind 10 and five disrupted oncology trials, respectively. Some of the affected companies in oncology are Boehringer Ingelheim International and BioNTech, with 12 and nine disrupted trials, respectively. Among the affected oncology pipeline agents are Aravive’s Aravive-S6, Immunomedics’ sacituzumab govitecan, and Jazz Pharmaceuticals’ Vyxeos, each with three affected trials. Whether the development of these products will be affected adversely in the long term remains to be seen.

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