COVID-19 treatment and vaccine trials
ICON is currently working on numerous COVID-19 treatment and vaccine trials.
Rapid mobilisation advancing vaccine development
We have conducted more than 246 vaccine studies globally, including over 40 studies in respiratory viruses, within the past five years alone. In February ICON quickly mobilized its Vaccines, Infectious Diseases and Government and Public Health Solutions resources to assist both government and commercial clients in addressing the COVID-19 global threat and is already providing clinical monitoring and safety oversight on a number of new COVID-19 trials. ICON is a preferred partner for BARDA and has participated in seven studies during infectious disease outbreaks within the past 10 years, including two for H1N1 during a H1N1 pandemic and three for H7N9.
ICON supports Pfizer and BioNTech on the investigational COVID-19 vaccine trial
Trial capabilities key to enabling agility and speed in global study involving 44,000 subjects
ICON mobilised a large global team of therapeutic and operational specialists to partner on the implementation of Pfizer‘s and BioNTech’s strategic plan and framework for the monitoring of the trial, which included a high level of remote clinical monitoring and source data verification in addition to on-site monitoring, safeguarding data quality and integrity in the evolving pandemic environment.
Pandemic respiratory vaccine clinical trials
In this whitepaper, ‘Pandemic respiratory vaccine clinical trials: A departure from business as usual’, we focus on the corresponding success factors that can keep pandemic respiratory vaccine trials running at optimal speed and efficiency.
Webinar: Keeping your trial on track in the evolving environment of COVID-19
In this webinar, industry experts presented regulatory and operational insights to that enable you to be proactive now to protect patient safety and minimize disruption.
ICON has considerable experience in supporting trials of respiratory disease, infectious disease affecting respiratory function, and supporting investigational treatment. Additionally, our Medical Device & Diagnostic experts have conducted studies to aid in the diagnosis of respiratory conditions or with devices utilised to administer drugs in support of respiratory conditions.
As the COVID-19 pandemic evolves affecting the regulatory and clinical and landscape, ICON experts are available to support all aspects of your respiratory programme requirements.
Webinar: Navigating the “new normal” during COVID-19: A regulatory and clinical perspective for medical devices - watch webinar recording now
COVID-19 case studies
ICON is working on numerous COVID-19 clinical trials. Download the following case studies:
COVID-19 Vaccine manuscript development: (PDF) - One client needed to report, as quickly as possible, the phase 2/3 data from a global phase 1/2/3 trial that evaluated the safety, immunogenicity, and efficacy of their severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidate.
COVID-19 Vaccine study: (PDF) One client trial investigating a prophylactic vaccine study in healthy participants required rapid patient recruitment, site selection, and study start-up.
COVID-19 - Easing the regulatory burden: (PDF) Various regulatory agencies have all published new recommendations on how to manage clinical trials in the wake of the COVID-19 pandemic. To accelerate the development of COVID-19 treatments and vaccines in general, institutional review boards, ethics committees and regulatory authorities are expediting timelines. Where ICON has encountered countries that have not implemented expedited review times, we have reached out directly to ensure this is implemented.
COVID-19 Treatment: (PDF) One client trial investigating an antiviral treatment for patients with conﬁrmed coronavirus infection required rapid patient recruitment, site selection, and study start-up across multiple geographies.
COVID-19 vaccine challenges
Over the past decade, researchers have made great strides in vaccine research with gene sequencing, further development of mRNA and DNA vaccine platforms, and novel adjuvants for more traditional antigen based products. These advancements have enabled biopharmaceutical and government entities to respond to infectious disease outbreaks by fast tracking both vaccines and treatments in record time.
In the current pandemic, regulatory agencies such as the FDA and EMA and have expedited commercial approvals to bring safe vaccines and treatments to market. Groups such as CEPI and BARDA have enabled key assets and infrastructures to be leveraged in response to this pandemic.
However, numerous key development challenges to delivering a coronavirus vaccine remain.
Related blog: COVID-19 vaccine trials
Related media article: Cindy Dukes, VP Vaccines at ICON, features in an MIT Technology Review article 'Here’s what we have to do to show a coronavirus vaccine works'
How to ensure your trial data and patients remain safe during COVID-19
Cyber attacks have increased dramatically during the COVID-19 pandemic. Opportunistic cyber criminals can use the current pandemic to steal intellectual property and patient information.
The impact of COVID-19 on pharmacovigilance
The pandemic is affecting how clinical trials are managed, not just in terms of patient recruitment and immediate patient care but also in terms of data collection, analysis and safety reporting.
The shifting diagnostics regulatory landscape amid COVID-19
For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.
COVID-19 vaccine trials
The success factors that can keep pandemic respiratory vaccine trials running at optimal speed and efficiency.
Diagnostics on the frontlines of COVID-19
Need for rapid diagnostic testing to identify and track people infected by or exposed to coronavirus.
COVID-19 and respiratory devices
A dynamic market and evolving regulations.
Minimise the impact of COVID-19 on clinical trials with in-home clinical services
Adapting clinical trial protocols can help to keep participants enrolled and receiving treatments and assessments.
Managing trial participants with cardiovascular and metabolic disease during COVID-19
Impact of COVID-19 pandemic.
COVID-19, Influenza and cardiovascular disease - What is known?
Patients with cardiovascular disease are particularly susceptible to respiratory infections.
Preparing for Disease X
A look at the potential impact of Coronavirus.