Since the onset of the global pandemic, clinical trials have been more visible than ever. As a result, we’ve seen a drastic rethinking of traditional approaches to clinical trial design, and a remarkable acceleration towards patient-centric protocols.
As a new, more decentralised clinical trial landscape emerges, study organisers are leveraging technological advancements to increase patient enrollment and retention, and reduce the patient burden at every step of the clinical journey.
Historically, up to 80% of delays in clinical trial timelines are due to challenges with patient recruitment and retention, with 37% of sites under-enrolling and 11% failing to recruit a single participant. The latest research suggests around 40% of those who sign up for a study drop out before it completes.
As well as resulting in delays of up to six months on average, failure to recruit and retain patients in a clinical study can add staggering costs of between $600,000 and $8 million per day.
In this comprehensive guide to the future of clinical research, we explore the importance of turning innovation efforts in clinical trials towards patient benefit, ensuring all studies are efficient, inclusive and truly patient-centric.
Inside Clinical Trials Today
In the wake of COVID-19, clinical trial organisers were forced to innovate in the face of exceptionally challenging conditions to ensure clinical trial continuity. As well as supporting the search for a vaccine, all other clinical trials had to keep running. As a result, the industry has innovated at an unprecedented rate, with decentralised trial design at the heart of its efforts.
Enabling decentralised clinical trials (DCTs) has long been an ambition for study organisers, as the benefits to patients are clear. However, the uptake of DCTs prior to the pandemic had been relatively slow, with healthcare professionals taking a risk-averse approach due to the highly regulated nature of the industry.
Now, as we emerge from an uncertain period of trialling novel solutions, cutting-edge technology is being leveraged more effectively in clinical research, with patients playing increasingly important roles in the protocol development process.
Without the technology available today, the accelerated shift towards DCTs would never have been possible. Mobile health technology has given us access to more in-depth, real-world data capture as well as offering deeper insight into the patient experience. Integrated smartphone technology has enabled continuous feedback between patients and clinical teams, leading to improved data collection and ensuring drugs that reach the market are more effective.
Despite the technological advancements of the last few years, there is still a long way to go before all clinical trials are truly patient-focused. Diversity, accessibility and equality remain significant challenges.
Addressing Clinical Trial Diversity
Diversity in clinical trials is an important moral and scientific issue, as the effectiveness of a drug in one population does not always indicate it will be effective in all populations.
One study found Latinx populations are twice as likely to die of liver cancer compared to white people – and yet the role genetic factors play in this difference has not been investigated fully compared to white populations.
White men are by far the most likely group to be represented in clinical trials globally, which has led to harmful gaps in our understanding of many diseases and conditions, preventative factors, and the effectiveness of treatment across diverse populations.
Improving The Uptake of Decentralised Trials
Despite the global pandemic bringing clinical trials sharply into public awareness – resulting in COVID-19 vaccine trial enrolment reaching 80% higher than the industry average – in other disease areas participation is nowhere near as high. For example, in cancer care, less than 10% of eligible patients enrol in a clinical trial.
DCTs make clinical trials more accessible to patients who would face prohibitive challenges to participation in centralised studies, because remote monitoring, real-world data collection and home visits to administer treatment minimise or remove logistical, financial and accessibility obstacles involved in travel to study sites.
Despite this, there has been a long-term reluctance within the clinical trial industry to move towards fully decentralised models for a number of reasons:
- In early phase studies, drug administration tends to come with higher risk than later on in the development pathway – this means patients may be better served on-site with access to specialist clinicians and emergency equipment and protocols
- The use of unknown technology – such as wearable devices which are new to the market – may pose challenges to protocol compliance
- Finding specially-trained couriers who are able to deliver medication, medical supplies and equipment safely and legally
- Managing and processing a higher volume of patient data received via apps and wearables
- Continuity of patient care – for example, inconsistency in visiting HCPs could potentially be distressing for elderly or neurodiverse patients
- Full decentralisation may not always be the best solution – for example, in the case of cancer patients needing in-person screening with specialist equipment that can’t be replaced with online monitoring
As an industry, we know we must work together to overcome these obstacles and adopt DCTs and hybrid models wherever possible. Otherwise, resulting delays to clinical studies will become untenable.
Today, the average cost of developing just one drug is $2.6 billion, with sponsors losing $600,000 or more for every day a trial is delayed. According to recent research, only 13% of trials are ultimately successful and we have seen significant increases in the time it takes to get a drug to market in recent years.
Increasingly complex clinical study designs coupled with growing demand for larger and more diverse patient pools have made it harder to find eligible clinical trial participants. Approximately 20% of cancer clinical trials fail because of inadequate patient recruitment, while two-thirds of study sites fail to meet their enrolment goal.
Now, more than ever, the clinical research industry needs to focus on DCT innovation and focus efforts on boosting patient awareness, recruitment and retention to ensure study success. To do this, we must focus on individuals and let go of a one-size-fits-all approach which too often leaves patients feeling undervalued.
Read more on Why Decentralisation Is The Future Of Clinical Trials.
The Patient Experience
Successful patient recruitment is one of the most challenging aspects of conducting clinical trials. Even in today’s technology-enabled society, participant recruitment and retention remain two of the biggest threats to study success.
High rates of patient drop-outs force sponsors to halt trials or recruit again and incur considerable costs in terms of finance, time and effort, whilst simultaneously increasing the likelihood of study failure.
DCTs and hybrid models combat these issues by reducing the burden placed on patients. When clinical trial participation is more accessible, less time-consuming and less costly, recruitment and retention rates are likely to increase.
It’s important to note though, that this is only one piece of the puzzle – a decentralised study which fails to leverage technology to communicate better with patients, be flexible to their needs and improve engagement is still likely to suffer high drop-out rates.
No matter what clinical trial model we follow, we must ensure that every patient taking part feels valued, heard and appreciated. The future of clinical research relies on study organisers’ ability to listen and respond to the patient voice – this is the sweet spot where true innovation happens.
Transitioning To Value-Driven End Points
The current ‘gold standard’ for clinical trials is the randomised controlled trial. This approach has produced enormous amounts of high-quality data and evidence, resulting in the development of life-altering new treatments and important guidelines for clinicians.
However, the clinical trials of the future will focus on value-driven endpoints, measuring patients’ subjective experiences in relation to objective measurements.
Gathering this kind of data necessitates a low-burden, decentralised approach – one which allows underrepresented populations including disabled people, the elderly and children to participate in clinical trials using readily-available, integrated technology that fits into their daily lives.
MedTech Evolution & Healthcare Digitalisation
At mdgroup, we’re focused on advancing the technology used in clinical trials to give patients a seamless experience when it comes to appointments, travel, expense reimbursement and more.
As part of our innovation process, we look at technologies which are widely used in other industries and ask how they might be applied to clinical trials and patient care.
Sometimes, we find patients prefer not to use the digital solutions we think might be helpful. In these cases, we continue to innovate: sourcing or building alternative solutions to meet their needs. Finding ways to communicate with patients no matter how confident or skilled they are with digital technology is essential in ensuring better trial outcomes from DCTs.
Read more about how we deliver remarkable patient experiences.
Mobile Data Collection
Advancements in technology enable us to gather and analyse patient data in increasingly novel ways, ensuring clinical trial data is readily available, relevant and useful to all stakeholders.
By harnessing the power and potential of technology to organise and deliver mobile health services – such as HCP home visits to gather readings or administer treatment or enabling data capture through wearable devices and apps – we significantly reduce patient burden and dropout.
Instead of taking the patient to the site, we take the site to the patient.
Customisable Clinical Trial Solutions
Instead of designing clinical trials to suit available technology, trial designers and sponsors need to customise technology to suit the needs of patients and ensure required outcomes.
One global study of patient engagement initiatives with over 12,000 respondents found patients reported travelling to and from a site as the “most burdensome” element of clinical trial participation.
It also revealed patients’ desire for dedicated support services: 34% asked for concierge services such as transport to and from the study site, while 31% expressed a wish for mobile applications to deliver elements such as electronic surveys and visit reminders.
Of course, the uptake and success of digital solutions will vary according to factors such as age, region, race, ethnicity and education – yet another reason why a single-tier approach won’t work for every patient.
Instead, we need to focus on developing industry-leading solutions which allow researchers to “mix and match” from a selection of technology, patient and stakeholder-driven elements, creating a customisable clinical trial experience which achieves the same end goal.
While technology opens up a variety of potential solutions, these solutions only become workable when used as a conduit – not a replacement – for cultivating site/patient relationships.
How AI Could Disrupt Every Stage of Clinical Trials
Artificial intelligence (AI) powered technology has the potential to impact every stage of the clinical trials process, from patient selection and protocol adherence to advanced data analysis.
Computational tools have long been used in the drug design and discovery process, but AI can take these processes to a whole new level by making clinical research more efficient, accurate and cost-effective.
Ultimately, AI will play a major role in the future of clinical trials, making innovations possible that are fundamental for transforming the way trials are run.
Reducing Human Error
Testing new drugs is a slow, expensive process. By leveraging AI to replace complex manual processes which are vulnerable to human error, or pick up on biomarkers the human eye might miss, we have real potential to rapidly accelerate research and development timelines while improving the probability of approval.
Matching Patients to the Right Clinical Trial
Matching the right trial with the right patient is a time-consuming and challenging process for both the clinical study team and the patient.
Roughly 80% of clinical trials fail to meet enrolment targets and deadlines, and around one-third of Phase III clinical studies are terminated due to enrolment difficulties. In fact, less than 5% of cancer patients today are enrolled in clinical trials.
AI technology is already being leveraged to help study organisers select patients more easily.
Looking To The Future Of Clinical Trials
The collective shift towards decentralisation, coupled with investment in and uptake of technological innovations, is changing the face of clinical trial development.
A new precedent is now being set for an accessible, low-burden clinical trial model which puts the needs of patients first, and matches the right healthcare providers with the right solutions to deliver remarkable patient care.
The ongoing development of MedTech such as wearables and AI-powered systems means patients can be continually monitored from the comfort of their homes or workplaces, whilst data is rapidly and securely shared with their medical team.
Innovative wearable devices coupled with AI technology will enable ever more reliable gathering and efficient analysis of high-frequency, real-world data, meaning studies require fewer participants, can recruit faster and meet shorter timelines.
Ultimately, if we are to tackle the greatest challenges to clinical trial success, we must work together as an industry. The convergence of technology, healthcare, research and patient experience will pave the way to a brighter future.
We’re on a mission to deliver remarkable technologies and experiences for patients taking part in site-based and decentralised clinical trials. We support all sizes of pharma and biotech to attract, engage, maintain and support patient participation in clinical trials. We support DCTs around the world, all underpinned by our latest innovations in healthcare technologies. Let’s make your next study remarkable. Contact us now to discuss how?