Clinical and Medical Research
How Approaches to Clinical Research are Set to Change in the ‘New Normal’ 2020 was an extraordinary year for the whole of humanity. But for one sector, it proved to be particularly defining – clinical research. Even before the COVID-19 pandemic, the world of clinical research was undergoing large-scale changes, utilising new technologies and moving towards a more patient-centric approach to attract volunteers, increase efficiency, protect patient safety and speed up the delivery of new medicines. Then, in March 2020, as societies all but shut down, the scientific community faced their biggest challenge yet – to identify treatments and develop new vaccines for the novel coronavirus – while the world collectively held its breath. But while unprecedented feats were achieved in clinical research for COVID-19, many other important projects focusing on a wide range of diseases and conditions, including cancer, were halted and patient recruitment stopped entirely. In fact, a survey showed that more than 75 per cent of pharma and biotech companies faced significant disruption in their clinical trials last year – the full effects of which we are yet to understand. In this story of two halves, there are winners and losers. But what do the events of 2020, confounded with other forces such as political shifts and innovative technologies, mean for the future of clinical research, both in the UK and globally? The Lasting Impact of COVID-19 Vaccine Trials on Clinical Research Developing and delivering new vaccines for COVID-19 worldwide has been – and continues to be – one of the greatest challenges faced by modern pharma. It’s been over 13 months since the Chinese health authorities and the WHO announced the discovery of a novel coronavirus on 9th January 2020, followed by the full sequence of the coronavirus 64 INTERNATIONAL PHARMACEUTICAL INDUSTRY
genome being shared over the weekend of 11th–12th January. According to the COVID-19 vaccine tracker, at the time of writing, there are currently 10 authorised and approved vaccines being delivered to patients worldwide, and many more remain in development. Israel is currently leading the way with its vaccination campaign and is already witnessing the positive real-world impact – falling infection, hospitalisation and death rates. It’s quite remarkable writing these words only a year on since the pandemic became a worldwide public health emergency. The international scientific community, investors and governments alike have come together at this time of crisis for the good of mankind. It’s not an overstatement to say this feat was only made possible by the flexibility and ingenuity demonstrated by those in the clinical research field and the goodwill of trial participants. And the hard work continues to this day, as more treatments are being tested and other vaccines make their way through the clinical trials process. The research sector should be applauded for adopting new approaches at rapid speed in order to cope with the challenges presented by COVID-19. Many of these transitioned to virtual approaches overnight to interact with and monitor trial patients, made possible by a range of innovative technologies. Moving forwards, it’s important these lessons learned during the pandemic are remembered and adaptations are made to protect the research process against future emergencies. What’s clear is that COVID-19 will permanently accelerate the use of remote technologies in clinical trials, reducing the need for in-person visits, to drive efficiency and uphold the highest levels of patient safety. Realising the Potential of Patient-centric Clinical Trial Design Clinical research is the heartbeat of pharma-
ceutical drug development; a rigorous process of testing and analysing real-world data to be certain a treatment or device achieves what it set out to do in a safe way. However, a fundamental flaw continues to affect the trial process’s biggest stakeholder – the patient. Limited patient-centredness is cited as causing or contributing to a number of issues, including non-response bias in surveys where candidates are left unable to respond to a question because the answers do not reflect their position; key populations being omitted from clinical trials (on the grounds of age, ethnicity, gender or socioeconomic group, for example) can reduce the accuracy of and actionable findings from trial results; and a lack of understanding over the trial findings and outcomes which are often only published in medical journals. Not paying due attention to or collecting information about the patient experience, including the recruitment process, is also a missed opportunity for researchers to improve trial design a step at a time. For example, asking patients for feedback on how useable informed consent documents can give clear insights into how that particular part of the process can be made smoother early on. Over recent years, there has been a growing movement towards patientcentredness in clinical trial design. Patient advisory groups dedicated to helping tailor clinical trial design are becoming more commonplace, offering first-hand guidance on ethical and procedural components and identifying pain points that could be affecting patient recruitment and retainment efforts. A literature review by the Patient-Centered Outcomes Research Institute (PCORI) in 2019 found evidence that consulting with patient advisers during a clinical trial has a positive effect on studies – including valuable contributions to research feasibility, acceptability, rigour and relevance. It’s clear patient engagement can support more relevant research through Spring 2021 Volume 13 Issue 1
