Beyond COVID-19: Restart, Recovery and Resilience

COVID-19 was officially declared a pandemic by the World Health Organization on 12 March 2020. As a critical part of the healthcare community, the global pharmaceutical industry has been committed to playing the biggest possible role in the response to this outbreak.

In the UK, the pharmaceutical industry has created new partnerships with academia, charities, Government and NHS to ⁽¹⁸⁾:

• research medicines and vaccines to fight COVID-19
  
• mitigate any impact that the global supply chain, manufacturing and transport disruption may have on the availability of medicines and health technologies
  
• support the opportunities for thousands of highly skilled people to volunteer where most needed
  
• build capacity for COVID-19 testing and diagnostics.

The UK’s COVID-19 R&D response has been impressive, with Government setting up a process for nationally prioritising and approving Urgent Public Health studies ⁽¹⁹⁾. The first studies through this process were approved in March, and an ever-increasing number of participants have been recruited since then, to a range of interventional and observational, commercial and non-commercial studies ⁽²⁰⁾. This response has been made possible through the monumental efforts of patients, the public and research and healthcare staff across the life sciences sector, NHS and Government. Many clinical trials in other non-COVID-19 diseases were also proactively paused⁽¹³⁾, to help prioritise COVID-19 research and ensure optimal

We have also seen the adoption of new ways of working in the design, approval, set-up, recruitment and delivery of ongoing COVID-19 and non-COVID-19 clinical trials, which enable greater efficiency and flexibility. Examples include direct-to-patient shipments of investigational medicinal products, digitally-enabled remote approaches, including monitoring of patients, informed consent and electronic signatures ^{(21, 22)}, the use of data to support healthcare decision-making and research efforts, and the adoption of complex innovative design (CID) and large platform trials, such as RECOVERY ⁽²³⁾. This response has come with the support of national regulators, the Health Research Authority (HRA) and MHRA, with efficient approval and supporting guidance on managing clinical trials, making amendments, acquiring informed consent, pharmacovigilance and inspections ^{(24, 25)}.

Since May 2020, the UK has commenced a programme of restarting the paused non-COVID-19 research studies ⁽¹⁴⁾. Despite the NIHR issuing a framework to support decision-making by sites and sponsors, a number of challenges remain, such as patient recruitment, trial oversight via remote or onsite monitoring and lack of available research staff ^{(26, 27)}. Furthermore, with record high waiting times in England, the NHS’ capacity to deliver clinical services and research, for both COVID-19 and non-COVID-19 patients, is limited ⁽²⁸⁾.

As of 9 September, data from the NIHR CRN, shows that 45% of studies (2,676) are open to recruitment, with 36% of open studies recruiting since the 1 June ⁽²⁷⁾. The ABPI and pharmaceutical industry have been working with Government and the wider sector, in England (14) and the Devolved Administrations ⁽³¹⁾, to help identify bottlenecks in restart, share best practice and advise on possible solutions, driven by a shared ambition to successfully navigate the UK through this challenging restart.

While the comparative data presented in this paper describes the pre-COVID-19 clinical research environment, the areas for improvement remain the same, with the need for change merely amplified through the 2020 pandemic. The manner in which we restart clinical research activity is a critical first step in the UK’s journey to recovery and will be crucial for the resilience of the healthcare system against any future public health emergencies. An evolution of the NHS is a critical part of this and the ABPI and pharmaceutical companies are committed to working with Government and the life sciences sector to make these changes happen.