It goes without saying that COVID-19 has had a tremendous impact on our global society and economy.
In fact, as lockdown was initiated across Europe at the start of March, we quickly saw the impact of this pandemic on clinical research activities across the various regions. Within the life sciences industry, we were confronted with challenges not experienced before, which have resulted in an acceleration of innovation across many areas, most notably the increasing need for digital and virtual capabilities to enable continuity of service.
The life sciences industry has traditionally been more cautious and reticent in its approach to adopting virtual trial capabilities. This is both understandable and evident when you look at particular therapeutic areas such as ophthalmology where there is dependence on device-led diagnosis and treatment, adding complexity to the evolution of virtual and remote offerings. What’s more, the existing model and processes have long been accepted and have a proven track record and history of success.
However, the pandemic has made the continuance of clinical research in this way very difficult and there has been a significant reduction in the number of trials progressing during this time. According to research by University College London, clinical research in England alone decreased by 87% at the peak of the pandemic. The question is whether this could have been avoided, or reduced if more virtual trial capabilities had been employed and accepted at the start of the pandemic.
There are several key considerations and lessons to explore as we transition into the winter months. There has been a sharp increase in COVID-19 cases across the UK and Europe, with further regional and local restrictions being enforced, as well as second lockdowns, and this could have a continued impact on clinical trials if we don’t adapt accordingly.
The changing nature of clinical trials in a post-pandemic world
The clinical research industry is growing, with data indicating record numbers of new studies and patient participation over recent years. The European region has numerous excellent research sites, a huge amount of clinical trial expertise and a large clinical trial subject pool that could contribute and add value to research activities. As a result, there is an opportunity to contribute to the development of various modalities to help drive innovation and change for improved clinical trial continuance.
These modalities must of course meet the requirements of the regulators to provide assurance of safety while also enabling ongoing clinical trial activities. For example, using a combination of remote and virtual technologies could assist in optimising the pre-screening of patients, site feasibility and selection activities, as well as clinical trial delivery.
Best practices for finding success in unprecedented circumstances
In reviewing the past six months – the upheaval, the pressures, the successes and failures – it is the accelerated focus and drive on innovation that we must continue to push forward.
Key considerations for success might be:
1. Focus on technology
Recent government restrictions that affect many of the markets across the globe, including multiple countries within Europe, have forced many clinics and organisations to be more digitally minded in their approach – whether that means adopting a hybrid or fully decentralised virtual model approach.
This virus has pushed the clinical trial industry to consider modalities that have the ability to enable at-home testing in combination with
remote working practices and digital technology. This will ensure continued trial conduct in a more convenient and safe manner for the patient without impacting the investigator’s role in ensuring adequate safety.
We have seen increases in remote pre-screening practices, e-consent and remote monitoring acceptance over recent months. These modalities, among others, can be used as we develop best practices across the whole of the life sciences sector to drive patient-centric, efficient and safe clinical trial modalities to assist in the continued improvement of clinical trial performance.
Identifying the right tools, data insights and infrastructure to develop both hybrid and full virtual trial environments will be fundamental to the future of clinical trials.
Not only is it important to consider the technology, data and usability remotely, but also the accuracy of the results, and whether these provide the levels of assurance needed at a patient, clinician and regulator level to allow market acceptance.
2. Building strong partnerships
Working together cross-functionally facilitates the development of approaches that are more likely to satisfy the needs of all relevant stakeholders and increase the potential for market acceptance. Input from all aspects is so important when considering remote clinical trial and virtual assessment modalities.
Clinical Research Organisation (CRO) partners can assist in facilitating this, with access to sponsors, sites, investigators and patients. Specialised CROs also offer an operational expertise and therapeutic knowledge that enables an understanding of the safety and clinical endpoint assessments to assist in this progressive evolution of clinical trials.
The endpoints being used in protocols are essential to demonstrate the true benefits and improvements that new treatments can have on the quality of life of patients. Patients must be at the centre of all we do within the clinical trial industry.
Our goal, independent of being part of the site, sponsor or service industry sector, is to help in the development of treatments that could benefit the end user, while ensuring continued safety and excellence in trial conduct. This will help to drive clinical trials into a new era that meets the needs of all involved.
3. Relationships matter
The clinical trial industry is well equipped to handle crisis and change in a manner that always prioritises staff and patient safety. This has been clearly demonstrated over recent months in the wake of COVID-19.
Maintaining working relationships between stakeholders in clinical trials is essential for success. Implementing a flexible and agile approach to protocols, standards and processes ensures that research activities can continue and ultimately patients are more likely to have access in the future to novel treatments no matter what the external circumstances may be.
Holistic stakeholder engagement is crucial as we look to innovate in order to meet the needs of our clinical trial subjects and to ensure that investigators can attain adequate assurance remotely, particularly to maintain patient safety throughout the duration of a clinical trial in light of COVID-19.
These relationships will thrive in the presence of effective and open discussion across all stakeholders to ensure continued development, innovation and success within the clinical trial industry.
The future is bright
In conclusion, the COVID-19 pandemic has helped us progress as an industry in a way we didn’t foresee or think possible even a year ago. We are at an exciting point of this journey where we have the opportunity to push the boundaries of innovation to benefit all.
As we look to the future of clinical trials across the globe, innovative modalities that allow for market acceptance and conduct of more virtual assessment and oversight are of increased interest for the entire industry. We face a time where innovation and collaboration could result in significant advances to ensure continuance of research in a safe, convenient, meaningful and efficient manner for all.