As the world searches for new, life-saving medical treatments, the global clinical trials market is expected to grow at 5.7% per year to an overall value of $69.5bn by 2028.
But the process must evolve in order to meet this demand. Traditional trials are often complex and drawn-out, suffering from high costs and inefficiencies. Recruiting volunteers and patients, and then being able to retain them has long been a problem.
As the industry faces even more pressure due to the prospect of future infectious disease outbreaks similar to the coronavirus pandemic, these traditional trial models and practices are no longer sustainable.
The industry needs a new and innovative approach to clinical trials – one that will ensure patients have access to life-saving treatments, quickly and safely, regardless of black swan events like the global pandemic. Under these pressures, the industry is coming together to engage in innovation and modernisation.
Decentralised clinical trials that can take place from a patient’s home are clearly gaining ground. A recent study found 76% of researchers are now running decentralised trials due to the pandemic, with 38% indicating more than half are decentralised. These trials are becoming increasingly possible thanks to technologies such as artificial intelligence, machine learning and cloud computing, and it’s also sparking a renewed drive for patient-centricity across the health sector.
Challenges to uptake
Traditional clinical trials typically require a great deal of investment. The process is often marred by extensive and confusing paperwork that participants are required to complete.
The amount of travel involved along with the more recent fears of attending appointments in a healthcare setting where there is a perceived risk of being infected by the coronavirus have also been major barriers in uptake.
For hospitals and staff, who deal with constrained resources at the best of times, the challenge doesn’t stop after the recruitment drive has ended. Helping patients to stay on-board and avoid poor protocol adherence is another major issue affecting many clinical trials.
Alleviating bottlenecks
Remote monitoring and decentralised clinical trials are important tools to overcome the present situation and go a considerable way to alleviate these bottlenecks. They are far more patient- centric than traditional clinical trials, since they build convenience and flexibility into the process.
There’s no need for travel, nor the pressure to attend medical facilities – even for filling in the initial paperwork which can be done by electronic consent. Using digital technologies, the patient is empowered to act.
This has the potential to vastly improve compliance and recruitment rates. It also opens up the prospect of participation to a more diverse pool of people from further afield, since the trial is no longer limited by geographical proximity to a healthcare facility.
This diversification is vital to help ensure the safety and efficacy of new medicines across the population, rather than just one part of a population. All of this is critical to the success of clinical trials, and subsequently the faster, cheaper development of effective and safe drugs to market.
An ecosystem of new technologies
The move to decentralised clinical trials won’t happen overnight. Ultimately, it’s more likely there will be a hybrid approach, with patients engaging both on-site and remotely. It is clear that the pandemic has accelerated the acceptance of new technologies and devices that can, and should, be used to safely conduct decentralised trials.
One area demonstrating great potential is wearable devices. Whether these are worn on the wrist, or as an adhesive patch on the body, AI- embedded capabilities allow devices to measure patients’ heart rate or metabolism remotely. Others can test for antibodies or blood pressure.
A patient’s daily activity can even be monitored to provide a more comprehensive view, from body posture to sleeping patterns. These devices are linked through secure networks via the cloud that allow clinicians to view and analyse the data in real time.
It’s important to recognise there’s no ‘one-size- fits-all’ approach to this. Different trials require the adoption of different technologies, all of which can be mapped using digital strategies. Supporting decentralised trials through an ecosystem of technologies like video calling and electronic reminders can certainly improve patient compliance in trials.
From ensuring that participants take the correct medication at the correct time, to prompting them to record developments in an electronic diary, the move to digital solutions can help to improve patient adherence and morale during the process. As patient convenience improves, so does compliance and adherence to protocol, which leads to more accurate results and swifter development of new and safe medicines.
A better way to manage the data
Ultimately, success is dependent on capturing interoperable data and combining it with medical research from each stage of the process. Doing this allows researchers to show rigorous evidence of benefit to patients, along with any potential side effects, which can later be submitted to regulatory agencies.
Typically, however, this is not a straightforward process. It’s crucial that all the data – including any adverse reactions, the number of patients who drop out, the frequency and method of data collection – is accurately tracked, logged and analysed. This requires Herculean coordination of the pharmaceutical industry, physicians and patients to generate valid evidence.
This is made more complicated by an overly complex and fragmented industry model. For example, there are no universal standards for medical devices. Devices that measure heart or respiration rates can require calibration and a certain degree of understanding.
Also, companies have historically built digital solutions that best suit their purposes, making it more difficult to share data with already established systems in the healthcare sector. Both of these issues create a real challenge when it comes to effectively managing all the different platforms and data sources, as well as ensuring the quality, safety and security of patient data.
A significant incentive for decentralised trials is the collection of real-world data and real-world evidence, which provide an assessment over the lifetime of a trial. Data is captured continuously and in the context of participants’ lifestyle and health habits – all feeding into a bigger picture.
Ultimately, with the use of various different technologies, decentralised trials can collect more data from patients than traditional, site-based clinical studies.
Because these technologies can deliver data straight from the source, for example from wearable devices, they also reduce the need for additional data verification, which can reduce the timeline and the costs of clinical trials.
Additionally, they allow clinicians to keep better tabs on how patients are doing at home, alerting them to any health problems or side effects far more quickly.
A seamless process
Developing in-house solutions for decentralised clinical trials represents a significant deviation from the current resources, capabilities and expertise available within large pharmaceutical companies. But the benefits of implementing decentralised clinical trials fast outweigh the challenges, by reducing trial timelines and costs, and providing more accurate data.
To accelerate these trials, many start-ups and technology firms within the industry are actively working on finding a solution. AI, machine learning and cloud computing make up one area, but there are also other components working in the background to provide a seamless process.
Distributed ledger technologies such as blockchain, for example, are being used to minimise the distance between doctors and patients, and to improve the organisation and security of data capture.
Decentralised clinical trials are a game changer not just for the pharmaceutical and healthcare industries, but also for regulatory and governing bodies. Increased quality control and storage requirements, as well as up-to-date standard operating procedures, are all key benefits that can ultimately reduce the time it takes to get life-saving drugs onto the market.
Shielding against future disruption
Decentralising clinical trials are part of the modernisation of the industry moving forward. In a risk-averse, highly regulated environment, change is often difficult. However, the pressures of the pandemic are giving way to greater innovation within the industry, and the benefits of remote devices are clear.
Patient-centricity is key here. Building convenience and flexibility into the clinical trial process removes significant bottlenecks that the industry has previously struggled with, resulting in better recruitment and engagement levels, and more accurate data monitoring.
As we look to the future, decentralised trials provide a shield against major disruption, ensuring continuity in operations and, critically, the improved delivery of life-saving medication to patients.