Clinical trials are critical for the delivery of safe new medicines to the marketplace
Traditional clinical trials are costly, inefficient and logistically demanding. Recruiting volunteers and patients, and then being able to retain them has long been a problem. With the world expected to see more infectious disease outbreaks in future, traditional trial models and practices are no longer sustainable. The pharmaceutical industry needs a new and innovative approach to clinical trials – one that will ensure patients have access to lifesaving treatments.
Under these pressures, the pharmaceutical industry is coming together to engage in innovation and modernise. Particularly gaining ground are decentralised trials, where the trial process is moved into the patients’ home, rather than a traditional trial centre. Decentralised 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.
The complex nature of clinical trials
Trials have traditionally been marred by extensive paperwork at the start, the amount of travel required, and more recently, fears of attending appointments in a healthcare setting where there is a perceived risk. The challenge doesn’t stop after the recruitment drive either. Managing patients to stay on-board and avoiding poor protocol adherence is another major issue affecting the conclusiveness of many clinical trials.
Decentralised clinical trials 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. The patient is empowered to act. This has the potential to vastly improve compliance and recruitment rates, not to mention opening the prospect of participation up to a more diverse pool of people from further afield. All of this is critical to the success of clinical trials, and subsequently the faster, cheaper development of effective and safe drugs.
An ecosystem of new tech
The move to decentralised clinical trials won’t happen overnight. Ultimately, it’s more likely there will be a hybrid approach, a mix of onsite patient and remote visits. But the past year has certainly accelerated acceptance by medical professionals that new technologies and devices 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 a patch on the body, AI-embedded capabilities allow a device to measure a patient’s heart rate or metabolism remotely. These can be linked through secure networks, that allow clinicians to pick up the data and analyse it 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 out by digital strategies. That being said, an ecosystem of technologies to support decentralised trials, such as video calling and electronic reminders, can certainly improve patient compliance in trials. From making sure participants take medication at the right time, to prompting them to log down developments in their diary and remember when to attend remote check-ins, the move to digital can help to improve patient morale and adherence during the process. This can lead to more accurate results.
The better the data, the better the results
The success of clinical trials is dependent on capturing interoperable data and combining it with medical research. Doing this allows researchers to show evidence of benefit to patients, along with any potential side effects – which can later be submitted to regulatory agencies.
It’s crucial the data is accurate, and so all the data – whether it’s numbers of patient dropouts, adverse reactions, frequency and nature of data collection, must be tracked, logged and analysed. This, however, requires Herculean coordination of the pharmaceutical industry, physicians and patients to generate valid evidence. But the issue is made more complex given there’s no universal standards for medical devices. Any device measuring heart rate or respiration rate, for example, requires calibration and a sophisticated degree of understanding. This adds to the challenge of effectively managing the plethora of different platforms and data sources, as well as ensuring the patient data is high quality, safe and secure.
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. With the use of various different technologies, decentralised trials can collect more data from patients than at traditional site-based clinical studies. Because these technologies can deliver data straight from the source, such as a wearable device, they also reduce the need for additional data verification, speeding up and reducing the cost of clinical trials.
A shield against future disruption
The move towards decentralising clinical trials is part of the armoury and modernisation of the pharmaceutical industry, and patient centricity is key to this. Pressures are giving way to greater innovation between pharma companies, and the benefits of remote devices are clear.
Building convenience and flexibility into the patient process removes significant bottlenecks that the industry has previously struggled with – from better recruitment and engagement levels, to more accurate monitoring of data. As we look to the future, decentralised trials offer a shield against major disruption. This can help ensure the continuity in operations so critical for the industry to thrive and deliver lifesaving medicine.
About the Author
Carolina Rossi Wosiack is Managing Director, EMEA at CI&T. CI&T is your end-to-end digital transformation partner. As a digital native, we bring a 25-year track record of accelerating business impact through complete and scalable digital solutions. With a global presence of 3,000 professionals in strategy, research, data science, design and engineering, we unlock top-line growth, improve customer experience and drive operational efficiency.