Decentralised clinical trials: paving the way for modernisation
The pressures of the pandemic have brought into sharp focus the need for greater innovation and modernisation across the pharmaceutical industry. This is especially the case when it comes to traditional clinical trials, which have often been marred by costly, inefficient and logistically demanding processes. But things are changing and new technologies are making decentralised trials increasingly possible. Carolina Rossi Wosiack, Managing Director of EMEA at digital consultancy CI&T, explores the benefits these new technologies and processes will have on the industry.
The delivery of new medicines to the marketplace is the lifeblood of the pharmaceutical industry and clinical trials are critical to demonstrate their safety and efficacy. Between 2021 and 2028, the global clinical trials market is expected to grow at 5.7 percent per year to reach an overall value of $69.5 billion by 2028. However, despite this, the clinical trials process is being held back by costly, inefficient and logistically demanding processes.
Traditional trial models and practices are no longer sustainable for the industry, which is under more pressure than ever to deliver. The global coronavirus pandemic has brought into sharp focus the need for lightning speed R&D into vaccines and medical treatments. Not to mention the millions of dollars of investment at risk from patients being unable to visit healthcare facilities for their treatment. With the world expected to see more infectious disease outbreaks in the future, the industry needs a new and innovative approach – one that ensures patients have access to lifesaving medicines, irrespective of black swan events like the COVID-19 pandemic.
Decentralised trials, where the trial process is moved into the patients’ home, is an alternative which can alleviate some of the significant bottlenecks which occur in traditional trials. Moreover, they are gaining ground thanks to technologies such as artificial intelligence (AI), machine learning (ML) and cloud computing. So much so, that a recent study found 76 percent of researchers are now running decentralised trials due to the pandemic, with 38 percent indicating more than half are decentralised. Remote trials are becoming increasingly possible and this is leading to a renewed drive for patient centricity across the pharmaceutical industry.
Extensive paperwork and the amount of travel to and from clinical trial centres have traditionally hindered efforts to recruit volunteers. More recently, fears of attending appointments in a healthcare setting, where there is a perceived risk of being infected by COVID-19, has provided a huge setback. However, this is not just about the recruitment drive. Ensuring patients stay onboard and avoid poor protocol adherence is another major issue affecting the conclusiveness of many clinical trials.
Decentralised clinical trials can help alleviate some of these bottlenecks around patient uptake. They present a far more patient-centric approach, building convenience and flexibility into the process as the patient can undertake the trial from the comfort of home. There is no need for travel, nor the pressure to attend medical facilities – even for the initial paperwork, which can all be done through electronic consent. All of this empowers the patient to act. This means quicker, more accurate results, since greater convenience directly impacts compliance and adherence to protocol.
In addition, it can also drastically improve recruitment rates and, importantly, access a more diverse patient population, since the trial is no longer grounded to a specific healthcare facility. This diversification is crucial in helping ensure the safety and efficacy of treatments across the entire 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.
A digital solution
There are clear benefits to decentralised clinical trials; however, it is unrealistic to think these will be the ‘norm’ in years to come. It is much more likely that there will be a hybrid approach; a mix of onsite patient and remote visits, using healthcare facilities closer to the patient’s home, such as when an MRI scan is necessary. However, the pandemic has accelerated acceptance by medical professionals that new remote monitoring technologies and devices can, and should, be used to safely conduct decentralised trials whenever possible.
Committing to using available technology in clinical trials could revolutionise the process. One area demonstrating great potential is wearable devices. Whether worn as a wrist strap or as an adhesive patch on the body, AI-embedded capabilities allow these devices to measure a patient’s heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data in real time.
There is no ‘one-size-fits-all’ approach to decentralised clinical trials and different digital strategies can map out different technologies. That being said, an ecosystem of technologies will often be necessary to support these trials. Video calling and electronic reminders, for example, can improve patient compliance in trials – prompting participants to take their medication at the right time, to log down developments in their electronic diary and to stay mindful of when to attend remote check-ins. Ultimately, the move to digital can help to improve patient morale and adherence during the process, resulting in more accurate data and faster drug development.
Joining up the dots with data
Clinical trial success depends on capturing interoperable quality data and combining it with findings from all stages of medical research. To be able to submit to regulatory agencies, it is imperative you can show detailed evidence of the benefits new treatments have on patients, as well as any potential side effects.
However, generating valid evidence requires Herculean coordination from the industry and also from physicians and patients. Terabytes (or more) of data, including the number of patient drop outs, adverse reactions, frequency and nature of data collection and hours travelled to a site are just some of the complex data that typically needs to be tracked, logged and analysed.
Much of this work tends to be outsourced to clinical research organisations (CROs) who provide this service. Moreover, in the past companies tended to build digital solutions that best suit their purpose and that do not necessarily work with already established healthcare systems. This makes the present industry model over-complex and beset with organisation-specific dogma. To make matters more complicated, there is no universal standard for medical devices. Regulatory guidelines differ across geographies and this means, for example, that any device measuring heart rate or respiration rate requires calibration and a sophisticated degree of understanding. Taken together, there is a major challenge for the industry when it comes to effectively managing the different platforms and data sources – all while ensuring patient data is high quality, safe and secure.
Remote monitoring and decentralised trials can do much to remedy this, through the collection of real-world data and evidence. These provide an assessment over the lifetime of a trial; capturing more data, more continuously and in the context of lifestyle and health habits. With the use of various different technologies, decentralised trials can collect more data from patients than at traditional site-based clinical studies. Since these technologies deliver data straight from the source, they also reduce the need for additional data verification. This not only helps speed up, but also reduces the cost of clinical trials.
The armoury for modernisation
The pressures of the pandemic have brought into sharp focus the need for greater innovation between pharmaceutical companies. We have already seen this materialise in the unprecedented speed of vaccine development. Moving forward, decentralised clinical trials offer an effective shield against major disruption.
As the industry looks to modernise, the move towards decentralising clinical trials will play a pivotal part in this new flexibility and resilience. With patient centricity built into the process, you can remove significant bottlenecks – from better recruitment and engagement levels, to more accurate monitoring of data. This means better results and better results mean effective treatments reaching the market faster.
About the author
Carolina Rossi Wosiack is the Managing Director of EMEA at CI&T, a leader in driving digital transformation for global brands. For over 20 years, CI&T has been a trusted partner in helping Fortune 1000 companies drive growth and continuous innovation across business, people and technology.
Carolina is a seasoned digital executive with nearly 20 years of experience in innovative processes, people and products, combining strategic and analytic insights and various strategy methods across design thinking, growth strategies and agility. She has applied her expertise on a global scale across several industries in Europe, Brazil, the US and LATAM, ranging from pharmaceuticals to consumer goods, banking and telecommunications. Carolina has helped leading companies such as Roche, Sanofi, Johnson & Johnson and Ericsson to prepare and adjust their business for rapid adaptation in the digital world.