Across the world, companies are implementing strategies to manage the COVID-19 pandemic. Most industries recognise the benefits of technology, but pharmaceutical companies have traditionally been slower to embrace new ways of working. This is now changing and the industry is moving at hyper speed because the risk of not modernising has become greater than staying the same. Sponsors are learning fast that the advantages of adopting solutions such as decentralised trials, wearable technologies and real-time communication technology can no longer be ignored. Clinical trials will finally be pushed into the 21st Century, meaning greater patient safety, more accurate outcomes and the speeding up of drug development.
If this sounds overly optimistic, consider this: in response to the pandemic, the FDA, EMA as well as national-level European governments have issued emergency revised guidelines related to the conduct of clinical trials to help sponsors adapt to the global health crisis. The recommendations are intended to help protect patient safety and ensure trial data integrity meet acceptable standards. Not surprisingly, sponsors and clinical research organisations (CROs) have scrambled to assess technologies to allow them to safely continue care for seriously ill patients enrolled in clinical trials. At the same time, thorough documentation of deviations is critical so as to preserve trial data integrity – at least to the best of anyone’s ability right now. As they scramble to find what works, time cannot be wasted by exploring solutions that take a long time to implement and or need lengthy user training. The usually conservative pharmaceutical industry is showing signs that it can move quickly under pressure, which bodes well for the future of clinical trials.
Long overdue
Let’s go back a few years: in 2016, ICH Good Clinical Practice (GCP) Guidelines were modernised with the introduction of ICH E6 (R2). This required sponsors and CROs to implement a more robust and formalised risk-management process before starting clinical trial execution. The intent for this change was to make sure clinical teams took a measured approach to evaluating risks within clinical studies, utilising critical thinking and applying lessons learned from previously conducted trials.
Despite the great benefits of fully implementing this change in regulation, there was a lag in uptake. According to the Association of Clinical Research Organizations (ACRO), in 2016, 18% of new studies started applying a risk-based approach to monitoring. By 2018, this jumped to 61%, but full-industry adoption was still slow. Those working in the clinical industry saw tangible value in applying this methodology because it allowed for re-evaluating and re-assessing risk throughout the study lifecycle, but uptake was too gradual. The incredible range of technological options that could have helped sponsors and CROs apply these processes were also not seen as a priority.
How fast things change! The all-encompassing nature of COVID-19 has exposed aspects of the management and execution of clinical trials as unworkable. Reality has hit from all sides and the industry now must embrace change. Travel is one such example, the pre-COVID model had clinical monitors travelling from site to site to perform visits. Currently this isn’t possible, and it is likely that sponsors won’t want to go back to the old ways if tasks can be done effectively with remote working. For CRAs, their hectic schedule saw them acting as intermediaries between research staff, trial management and medical monitors and much of their time was spent travelling. With time freed up by operating remotely, productivity increases, saving both time and money.
Let’s take a closer look at the three primary areas that will become critical moving forward:
Patient safety
Site staff need to analyse how they’re tracking and communicating updates to monitors regarding critical to quality risk indicators. Monitors need to look at how they are informing site staff about changes in study visits and procedures. And study teams need to make sure everyone is getting the most up to date information. It’s also important to consider what tools are being utilised so that data trial subjects stay enrolled in the clinical trial and how they can stay informed about updates related to their study and the visits.
Data integrity
Points to consider include examining how issues related to data integrity will be escalated from the site to the sponsor and from the monitor to the site. How will communication be delivered to sites to explain the process for the management of ongoing clinical trials due to COVID-19 disruptions? How will protocol deviations be tracked and communicated? Protocols also may require amendments very quickly and sites will need to have the newest version available immediately. There is also a risk that COVID-19 could unintentionally impact results of other ongoing clinical trials, so documentation is critical to help preserve data integrity.
Evaluating risk
Site staff should understand how trends in high risk categories are being escalated to the CRAs and sites and CRAs will need to provide key study updates and clarifications to site personnel. Communication regarding these risks will be essential and time will be of the essence in most cases. Potential safety issues and critical to quality trends will need to be escalated quickly to CRAs and sites. Incorporating an efficient process to facilitate this important communication during and after the pandemic will be vital.
The industry has choice when it comes to technology. To really advance, however, we can’t just apply technology to old ways of doing things. For example, machine learning tools can help sites and CRAs get the right answer in real time, but this requires a shift from sponsors and CROs away from paper first. This will help reduce the potential for protocol deviations, ensuring the answers are available in an instant and eliminate guesswork – for example, inclusion or exclusion criteria. Additionally, predictive analytics can measure behavioural trends, enabling CROs and sponsors to determine who is accessing the documents and querying specific data within the protocol.
Another hot topic is decentralised trials. Due to COVID-19 disruptions, virtual patient visits have replaced some of the in-person assessments. We could see greater adoption of decentralised trials in the near future. However, again, decentralised trials require a fundamental shift away from paper-based protocols and study documentation in order to ensure all carers are informed in real-time of any study changes. From a patient perspective, wearable technology could support decentralised trials so participants will be able to collect data from the comfort of their homes. Wearable devices have the advantage of collecting data in real time and this data can be remotely reviewed, enabling clinical trial staff to quickly identify and respond to adverse events.
CROs, sponsors and research site staff can and will rise to the challenge during this time of crisis. There may initially be teething problems as they get used to the new way of working, but in the long run the progress made will change all our lives. It’s in everyone’s interest to ensure that clinical trials can still proceed despite the pandemic and to make the most of the opportunity to improve the efficiency and safety of trials, which in the long-term will help to get drugs to market on a faster timeline.
During periods of upheaval, historically huge technological and social changes tend to occur in a short period of time because of necessity and the willingness to innovate. This was true during wartime and is true now. It may have taken a once-in-a-lifetime event to modernise clinical trials, but I believe that now the tide has turned there will be no going back.
Gary Hughes is chief executive of Teckro, for more information please visit www.teckro.com
