The COVID-19 pandemic has understandably had a dramatic impact across the healthcare and pharmaceutical industry. These range from the short-term, such as the need to revise regulations and accelerate the shift to greater use of telemedicine, through to long-term, including the broader move towards self-sufficiency in the industry.
Arguably the most significant changes have been within the clinical trial process. During the first few months of the pandemic, the number of clinical trials that were being conducted actually fell slightly. However, once healthcare and pharmaceutical organisations began to get to grips with COVID-19, the number of trials rapidly increased.
Nevertheless, the main challenge facing the industry is not the risk of trials declining. Instead, Contract Research Organisations (CROs) need to be able to adapt to meet the ever-changing needs of the 'new normal' as the industry continues to progress towards greater virtualisation of processes.
The virtual challenge
To its great credit, the healthcare and pharmaceutical industry was able to respond quickly to the obstacles presented by COVID-19 in regards to the clinical trial process. More trials launched in June 2020 than ever before, representing a 17% increase year-on-year. Despite this resilience, there are a number of questions being asked with regards to how trials are going to be conducted in the future.
Patient participation and the transition to remote and virtual trials are pressing challenges that are impacting the clinical trial process. During the course of the pandemic, many industries have lacked the virtual capabilities required to connect and interact with people. The same is true for CROs, and their lack of effective ways to engage with both present and potential patients has resulted in delays. Some 48% of trials have missed their enrolment targets for the year 2020 and in addition, a further 85% have been delayed.
Virtually-enabled trials are essential to the continued success of clinical trial processes. Many trials that were taking place at brick-and-mortar locations are now having to be conducted in a decentralised way. On top of this, digital engagement with participants needs to be improved, simplified, and personalised through the more intelligent use of data. Given that around 50% of the cost of a clinical trial is monitoring, the opportunities for cost improvement are significant.
Embracing new tools, gradually
It’s clear then that CROs need to embrace the latest technologies in order to offer customers better solutions and tools for clinical trials. Building a portfolio of remote access solutions that can support decentralised trials is a good starting point.
However, the reality of the situation is that historically the industry has been quite risk-averse and reluctant to embrace change. This means that new technology can sometimes be adopted slowly, or not at all. Lots of organisations in the industry are satisfied with the technologies they currently deploy, preferring to leverage those instead of adopting a new system, even if said system would be more efficient. The status quo, although not taking advantage of all the opportunities available, is still working, after all.
The COVID pandemic has changed this situation and acted as a catalyst for change. The need for process efficiencies brought about by a need to reduce costs is challenging the way in which trials are managed, especially when one considers that typically around 50% of the cost of a trial is monitoring.
CROs would do well to listen to their patients. 60% of patients said that they would consider using new technology to help them stay more engaged with the trials process. CROs might do well to take note and action on this. Therefore, the solution is to implement a platform that offers two things: greater efficiency for CROs and improved engagement for patients.
How to overcome these obstacles
For the healthcare and pharmaceuticals industry to progress, an agile and efficient integrated platform must be developed. An integrated platform provides a singular source of truth, in addition to user-friendly tools, and a greater amount of real-time data analysis. This enables workers in the industry to perform their duties with increased efficiency.
Technology can play an important role in helping CROs to scale. For example, if an organisation has its trial information stored in many different places, it can be challenging to find one source of truth, whilst it also makes it difficult to obtain information, resulting in delays. Where technology comes in is that it can help an organisation to develop a more centralised platform that meets the needs of a fast-growing organisation with continuously evolving processes.
This is only the tip of the iceberg for many organisations. For those that have already become more digitally capable in recent years, companies are examining what more can be done virtually across clinical trials to improve processes and gain efficiencies in the management of units, resources, and time. By being able to access real-time data via an integrated platform, an organisation can obtain data from a trial much more quickly, whilst data can also be shared more easily with the regulatory agencies.
Additionally, the patient recruitment system is improved as remote trials allow for a much broader demographic to participate in the trials. Looking at this from an operations point of view, a centralised platform enables there to be a focus on people and processes. It uses technology to improve synergy among teams and increase employee satisfaction. For example, the platform might enable alerts and notifications, so that further activities can be automatically triggered when a milestone is reached or a task is completed. Previously, this would have relied upon an individual to remember to alert someone else and manually start the next project, with the obvious risk that errors and delays might creep in.
Looking to the future
Despite the COVID-19 pandemic introducing some extremely challenging obstacles to the clinical trial process, it has also given the industry a unique opportunity to re-examine the way in which things have previously been done.
Whilst new technology won’t be adopted overnight and the shift to virtual trials won’t be entirely straightforward, those in the healthcare and pharmaceuticals industry realise that CROs must be agile in order to keep up with the ever-changing demands presented by the ongoing COVID-19 pandemic. For this industry to progress, it must embrace new technology platforms, develop new strategies to engage patients, and continue to look for new methods that can improve data quality and processes whilst focusing on how to maximise the trials integrity and efficiency.
Nevertheless, there is the possibility that more conservative CROs and sponsors, in addition to some trials, prefer to use a hybrid approach since it is crucial to remember that not all clinical trials are alike. Although some of these trials can be easily adapted into remote or virtual trials, this is not necessarily the case for all of them. Currently, the majority of trials taking place are device trials that require both actual patients and time in the operating room. Ultimately, the move to a more digital trials process offers a myriad of benefits, but also represents a big change in enrolment and monitoring requirements.
Andy Campbell is a global solution evangelist at FinancialForce