How Approaches to Clinical Research Are Set to Change in the ‘New Normal’

2020 was an extraordinary year for the whole of humanity. But for one sector, it proved to be particularly defining – clinical research.

Even before the COVID-19 pandemic, the world of clinical research was undergoing large-scale changes, utilising new technologies and moving towards a more patient-centric approach to attract volunteers, increase efficiency, protect patient safety and speed up the delivery of new medicines.

Then, in March 2020, as societies all but shut down, the scientific community faced their biggest challenge yet – to identify treatments and develop new vaccines for the novel coronavirus – while the world collectively held its breath.

But while unprecedented feats were achieved in clinical research for COVID-19, many other important projects focusing on a wide range of diseases and conditions, including cancer, were halted and patient recruitment stopped entirely.

In fact, a survey showed that more than 75 per cent of pharma and biotech companies faced significant disruption in their clinical trials last year – the full effects of which we are yet to understand.

In this story of two halves, there are winners and losers. But what do the events of 2020, confounded with other forces such as political shifts and innovative technologies, mean for the future of clinical research, both in the UK and globally? The Lasting Impact of COVID-19 Vaccine Trials on Clinical Research Developing and delivering new vaccines for COVID-19 worldwide has been – and continues to be – one of the greatest challenges faced by modern pharma.

It’s been over 13 months since the Chinese health authorities and the WHO announced the discovery of a novel coronavirus on 9th January 2020, followed by the full sequence of the coronavirus genome being shared over the weekend of 11th–12th January.

According to the COVID-19 vaccine tracker, at the time of writing, there are currently 10 authorised and approved vaccines being delivered to patients worldwide, and many more remain in development.

Israel is currently leading the way with its vaccination campaign and is already witnessing the positive real-world impact – falling infection, hospitalisation and death rates.

It’s quite remarkable writing these words only a year on since the pandemic became a worldwide public health emergency. The international scientific community, investors and governments alike have come together at this time of crisis for the good of mankind.

It’s not an overstatement to say this feat was only made possible by the flexibility and ingenuity demonstrated by those in the clinical research field and the goodwill of trial participants. And the hard work continues to this day, as more treatments are being tested and other vaccines make their way through the clinical trials process.

The research sector should be applauded for adopting new approaches at rapid speed in order to cope with the challenges presented by COVID-19. Many of these transitioned to virtual approaches overnight to interact with and monitor trial patients, made possible by a range of innovative technologies.

Moving forwards, it’s important these lessons learned during the pandemic are remembered and adaptations are made to protect the research process against future emergencies.

What’s clear is that COVID-19 will permanently accelerate the use of remote technologies in clinical trials, reducing the need for in-person visits, to drive efficiency and uphold the highest levels of patient safety.

Realising the Potential of Patient-centric Clinical Trial Design Clinical research is the heartbeat of pharmaceutical drug development; a rigorous process of testing and analysing real-world data to be certain a treatment or device achieves what it set out to do in a safe way.

However, a fundamental flaw continues to affect the trial process’s biggest stakeholder – the patient.

Limited patient-centredness is cited as causing or contributing to a number of issues, including non-response bias in surveys where candidates are left unable to respond to a question because the answers do not reflect their position; key populations being omitted from clinical trials (on the grounds of age, ethnicity, gender or socioeconomic group, for example) can reduce the accuracy of and actionable findings from trial results; and a lack of understanding over the trial findings and outcomes which are often only published in medical journals.

Not paying due attention to or collecting information about the patient experience, including the recruitment process, is also a missed opportunity for researchers to improve trial design a step at a time. For example, asking patients for feedback on how useable informed consent documents can give clear insights into how that particular part of the process can be made smoother early on.

Over recent years, there has been a growing movement towards patientcentredness in clinical trial design. Patient advisory groups dedicated to helping tailor clinical trial design are becoming more commonplace, offering first-hand guidance on ethical and procedural components and identifying pain points that could be affecting patient recruitment and retainment efforts.

A literature review by the Patient-Centered Outcomes Research Institute (PCORI) in 2019 found evidence that consulting with patient advisers during a clinical trial has a positive effect on studies – including valuable contributions to research feasibility, acceptability, rigour and relevance.

It’s clear patient engagement can support more relevant research through

Similarly, telemedicine is now frequently used for routine patient monitoring and follow-ups, particularly in Phase I studies. The method can also be used to measure select objective outcome measures; however, the data collected isn’t likely to receive regulatory approval. Until this point is reached, we’re unlikely to see a full switch from in-person monitoring to virtual.

Another exciting area of development is intelligent devices and packaging, creating secure two-way communication pathways between patients and clinicians during trials, and helping to decentralise them. Perennial encryption technology is protecting the sensitive data being collected and shared with trial leaders.

better alignment with patients’, as well as clinicians’, real-world needs and concerns.

As such, funders and research institutions need to establish engagement policies and provide resources to support research that is more fully responsive to end users’ needs. Two-way communication is also vitally important, rather than simply using patient involvement and feedback as a one-way input. Ultimately, evidence will be more useful and relevant to decisionmaking when patients and stakeholders are fuller participants in the research process. The Potential of Technology to Transform Clinical Trial Design Advancements in healthcare and monitoring technologies are accelerating this cultural shift towards patient-centredness and their application has been a key driver of success in recent COVID-19 clinical trials.

The global pandemic forced the international clinical research community to accelerate the use of digital technologies to alleviate disruptions, mitigate risks and develop new treatments and vaccines under extreme time pressure.

In the “new normal” which is still being disrupted by the novel coronavirus over a year on since the first cases were reported around the world, we expect to see a mass adoption of virtual introductions and check-ups which will minimise the need for patients to travel to investigative sites, as well as increased device integrations with consumer and medical data capture tools.

This, in turn, will simplify patients’ participation in clinical trials and improve their overall engagement, helping to drive medical advancement forward and encourage more volunteers to join (and stay in) trials.

Perhaps the simplest step in moving towards a more patient-centric trial is the routine use of eConsent and telemedicine methods.

For over three years now, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has allowed the use of electronic methods for seeking, confirming and documenting informed consent for participation in research. It enables potential research participants to be provided with the information they need to make a decision via a tablet, smartphone or digital multimedia. This digitalisation is credited with improving understanding, providing feedback on how consent materials can be improved, reducing dropout rates and enabling process efficiencies.

Wearable devices worn by the patients during trials is one component of this new digitalised approach, allowing clinicians to track and analyse health information such as heart rate and pulse, temperature, blood oxygen levels, stress levels, breathing rate, and even different types of brain activity in real time outside of a hospital setting.

Essentially, the device (usually a bracelet) acts as a personal assistant during the patient’s everyday life at home, monitoring their health status and alerting them about abnormal conditions, medication reminders and medication tracking. The device can also facilitate tracking of many outdoor and indoor activities to give a greater sense of their lifestyle during the trial.

A second component is the integration of intelligent technology into existing medical

packaging (such as blister packs) or devices. This is chipped with a wireless electronic component that allows tracking of drug usage as soon as the tablet is ejected from the blister or the device is used. In most cases, contact materials are not affected and the digital enablement, along with options for child resistance, are added as additional layers requiring no regulatory approval.

Each time a tablet is removed, or a medical device is used or activated, a signal is sent from the packaging or device to the bracelet. The bracelet will then send its information to clinical trial administrator team either directly, or via a smartphone to the cloud, then to the host. This transmission of data can be programmed to occur in real time or as a scheduled event.

Research organisations across the board are experimenting with new technologies such as these to streamline clinical research design and improve the patient experience.

Generally, organisational agility is a major contributing factor to how widely and how quickly these technologies are trialled and adopted, with smaller, flatter organisations less hindered by bureaucracy.

Larger organisations, on the other hand, are more likely to establish a task force to prepare and monitor new trial designs using remote technologies without significant oversight from senior leadership. Piloting, however, is common in both scenarios before a technology is widely rolled out.

It won’t be until regulators catch up with these advancements and offer clear guidance on how they will interpret the data and insights gained during the approval process that we truly start to leverage the power of these remote technologies.

Moving Towards a Cloud-based Model As trials become decentralised, more and more sensitive patient data is being collected, analysed, shared and stored.

While this is a necessity from a scientific development and patient experience perspective, it does create security concerns over how data in clinical trials is being handled and these concerns risk slowing innovation and adoption if left unresolved. Other concerns include false ownership of shared data and invalid secondary analyses.

Cloud-based solutions offer the greatest level of security and accuracy in secondary analysis, as well as simplifying the process of uploading, analysing and sharing data gained from remote healthcare technologies and onboarding stages. Cloud software can also help the community use anonymising techniques more efficiently, upholding patient privacy standards when dealing with extraordinarily sensitive data.

To solve this inherent problem of balancing data sharing while ensuring that patient privacy is protected, cloud technologies allow researchers to handle both synthetically generated and real clinical datasets to conduct both exploratory and hypothesis-driven research without compromising patient privacy.

This means researchers can gain meaningful insights earlier in development and extract maximum value from existing data, from anywhere in the world.

Additionally, cloud-based clinical trial platforms enhance collaboration between sponsors and investigators and allow information to be shared and managed quickly and securely, which leads to increased productivity.

To summarise, the key benefits of moving towards a cloud-based model for data capture, analysis and storage are as follows: • Increased transparency and real-time visibility into clinical trial operations and data • Enhanced collaboration between investigators, sponsors, and partners • Increased efficiency and speed to conduct trials • Streamlining processes, improving the patient experience and candidate retention • Reduced costs in completing trials • End-to-end visibility for security

Rising financial and time pressures on the life sciences industry will continue to drive changes in how clinical trials are conducted for many years to come and the COVID-19 pandemic has certainly accelerated digitalisation in the sector – a positive to come out of an extremely challenging year, professionally and personally.

Rich Quelch

Rich Quelch is an experienced global marketer within the healthcare and pharmaceutical sector. He has led the development of the Origin brand, positioning it as a world-leading supplier of innovative and ground-breaking pharmaceutical packaging devices, as well as offering a unique supply chain model which is disrupting the pharma industry. Established over 55 years ago, Origin offers customers a remarkable range of versatile packaging solutions that respond to the unique needs of the global pharmaceutical marketplace. Origin engages in the design, manufacture, and consolidated supply of pharmaceutical packaging, partnering with licence holders and CMOs.