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Enabling Bring Your Own Device clinical data collection
Bruce Hellman, CEO and Co-Founder, uMotif
I believe that clinical research is going through its moment of rapid digitisation, fuelled by the ubiquitous smartphone. This is similar to what’s happened in the shopping, banking and travel industries - where digital is a core part of business strategy.
I’m seeing that patients who are engaged with their condition and engaged with their research project capture more data. To this end, any technology that puts patients at the centre of this shift will be the most effective. I believe that enabling patients to use their own smart device (Bring Your Own Device) and its built-in user interfaces, sensors, and connections to other devices will have the biggest impact for clinical data capture. Importantly, this is because this technology will be most effective in offering patients a benefit themselves with the potential to empowering patients to manage their condition.
Benefits to patients, Sponsors and CROS
Firstly, looking from a patient’s perspective, tracking one’s condition over time has been shown to improve adherence to medication, deepen a patient’s understanding of their condition and interestingly improve their perception of quality of their clinical consultations.
The benefits don’t end there, when considering the use of BYOD data-tracking to support clinical research it allows for patient’s to be part of clinical trials with very low friction. Patients are using their own device which they are accustomed to, rather than taking time to travel to a research site or having to learn new technologies – all making research participation simpler for patients. Patients get the benefits of tracking and managing their conditions in return for providing their data for research, and by supporting clinical research, they are helping future patients with similar conditions.
This is helpful to you and it is helpful to me
Parkinson’s patient from 100 for Parkinson’s study
We at uMotif receive reviews from patients and trial participants for our application. Patients enjoy tracking their data and record how they are. The consensus is: ‘This is helpful to you and it is helpful to me’ (a quote from a Parkinson’s patient taking part in the 100 for Parkinson’s study).
A patient-centric approach delivers benefits for sponsors and CROs, with more engaged patients less likely to drop out, and recording more data – all of which can drive faster and more cost-effective research.
Which mHealth technologies has your company used in trials?
- Activity tracker
- Drug delivery device
- Mobile app
- Monitoring device
Challenges that still need to be overcome
When talking about challenges it’s worth keeping in mind that this approach is already proven to work at scale. Just taking uMotif as an example, we have captured over 65 million data points from over 20,000 participants with our platform across 21 conditions.
The challenges are not from a technology-readiness standpoint. The infrastructure exists and proven platforms are available. The challenge now is to ensure that patient-centric technology is seen as the essential core of a study, not an optional extra. Your favourite high street store no longer thinks in terms of ‘commerce’ and ‘e-commerce’ – both channels are part of their core business. Likewise, the time is now for digital patient experience to be seen as business-as-usual within clinical research.
ABOUT THE AUTHOR: Bruce Hellman, CEO and Co-Founder of data capture platform uMotif
Research and Development
Product pipelines. Clinical Trials. Challenges.
Microbiome Therapeutics Research & Development
As interest in the human microbiome increases, most of the research has been focused on opportunities around the gut microbiome, and this is reflected in the data; the majority (60%) of respondents' companies work in the gastrointestinal area. However, there are numerous opportunities in other areas, such as autoimmune disorders and the gut-liver axis (34%), oncology (34%), the gut-brain axis (25%) and dermatology (10%).
As expected, most respondents' therapeutics are not yet in clinical trials both in Europe and North America, whilst just 13% have reached Phase III.
*Excluding Not Applicable (55)
What type of products are your company focused on/are in your pipeline?
Microbiome Therapeutics Research & Development
Though clinical trials are still in early stages for the majority of therapeutics, there is relative optimism around pipelines. When asked to rate from 1-10 how robust their company's current pipeline is, 62% of respondents answered with 6 or above, giving an average score of 5.83/10. US respondents were slightly more positive than their European counterparts, with an average of 6.24 versus 5.89.
The types of product in those pipelines are dominated by emerging technologies (39%), probiotics (34%) and platforms (33%), with prebiotics (19%) and FMT (15%) lagging behind.
The most common technologies being used to aid this research and development are modulation of the gut microbiota (44%) and next-generation sequencing methods (43%). Other technologies added included:
- Nanotechnology
- Humanized animal models
- Incorporation of probiotics in nanofibers
- Intestinal enteroid models
- Macrophages
- Microarray
*Excluding Not applicable (55)
Microbiome Therapeutics Research & Development
R&D Challenges
When asked what the biggest challenge facing research and development, answers were fairly evenly split between regulation (25%), mechanisms of action (24%), investment and competition (19%), data standardization (17%). For Europeans, regulation is the biggest challenge (30%), whilst just 22% of North Americans said it was the biggest challenge they were facing.
*Excluding Not applicable (30)
Emerging Therapies
in 2020
In August 2019, 187 industry professionals responded to our survey on Analytics, Manufacturing & Supply Chain in cell and gene therapies. Dan Stanton, Editor of BioProcess Insider, analysed the results:
“When asked where the next big success and/or approval will lie in the cell and gene therapy industry, 47% ticked the “gene therapy” box. This may be slightly misleading as several gene therapies have already been commercialized, the latest being AveXis/Novartis’ Zolgensma (onasemnogene abeparvovec) priced at $2.1 million, and while we are still in the early days of the industry.
A quarter checked Solid Tumor treatment, which makes more sense as the CAR-Ts available and about to breakthrough are all focusing blood cancers. But more interesting is the written responses, with several stating allogeneic immunotherapies will be the next big thing in cell therapies.”
Download the Cell and Gene Therapy Supply Chain, Analytics and Manufacturing Report.
Oligonucleotide, Peptide, mRNA and CRISPR Therapeutics
In June 2019, we asked 124 professionals working in peptides and oligonucleotides where they saw the industry going in the future in our State of the Industry survey. A large part of the survey focused on new technologies, which hold promising ways to innovate the discovery and delivery of these advanced medicines. CRISPR was seen as the technology with the biggest potential to transform drug development in this field in the next three years, followed by nanotechnology.
Liquid chromatography-mass spectrometry (LC-MS) and mRNA made up the rest of the top four technologies.
Respondents were asked about the major advancements they expected to see in the next five years in each of the different areas. As the chart to the right shows, responses were varied, though common themes began to emerge. Delivery is a particularly important challenge facing those working on oligos, peptides and therapeutics, and one that the industry clearly hopes and expects to be improved on in 2020.
The efficiency of delivery is the biggest challenge facing the development of new peptides, oligos and mRNA therapies. The clearest finding in the burgeoning space is that R&D efforts are being hindered by delivery issues of these therapies.
Dan Stanton, Editor, BioProcess Insider
Download the full State of Oligo, Peptide, mRNA and CRISPR Therapeutics Report here.
Antibody Engineering and Therapeutics
Emerging technologies such as Artificial Intelligence, next generation sequencing and display systems are changing the way antibodies are being engineered at a rapid rate. At the same time, novel approaches to identifying targets and delivering antibodies are improving therapeutic effectiveness.
In August 2019 we conducted a survey of industry professionals on how they are working with these emerging technologies today and how that will change in 2020. 211 professionals responded, representing pharma and biotech (52%), academia (28%), CDMOs, and CROs (9%), and service providers and consultancies (6%) from North America (46%), Europe (34%) and Asia (14%).
When asked on a scale of 1-10 how likely it is that their company will increase its use of either bioinformatics and computational tools or AI and machine learning in the next two years, the most common response for both was 10 (as the chart left shows).
Taking an average score out of 10 for each of the different technologies, bioinformatics and computational tools was the more popular, averaging 7.44 / 10, compared to 5.64 / 10 for AI and machine learning. However, with both relatively high, it is clear that technology is likely to play a central role in antibody engineering in the immediate future.
Download the full Emerging Technologies and Novel Approaches in Antibody Engineering and Therapeutics report here.
Human Microbiome Therapeutics
As with any new field of research, there is a lot of excitement around the potential of human microbiome therapeutics, but also a lot of uncertainty. In June 2019 we conducted a survey of microbiome therapeutics professionals around the world, revealing unique insights into how the future landscape looks around emerging technologies, manufacturing and commercialization.
The future of microbiome therapeutics is exciting yet still unclear. Everyone in the industry has different views on where the research will begin to focus and where the next advances will come. Indeed, when asked about where the next major advancement in microbiome therapeutics would be, respondents were split between diseases beyond the gut (42%) and understanding the mechanism of action (42%).
Digging deeper into diseases beyond the gut, the areas that respondents saw the most potential for growth away from gastrointestinal (26%), were autoimmune disorders (28%).
The balance of excitement and uncertainty around the area was reflected perfectly when respondents were asked how likely it was that in the next two years their company will submit a marketing application for a microbiome therapeutic product currently in their pipeline. Answers were split, with 42% saying it was ‘Unlikely’ or ‘Very Unlikely’ and 44% saying it was ‘Likely’ or ‘Very Likely’.
No microbiome therapeutic has achieved marketing approval yet, and respondents were split in what they think the first one will be. The most common prediction was a probiotic, followed by a Fecal Micobiota Transplant (FMT), c. difficile treatment and an acne product.
Whatever the first approval turns out to be, 2020 is set to be an important year for the field of human microbiome therapeutics.
Download The Future Landscape of Microbiome Therapeutics report here.
Read on to explore insider insights
Discover SaMD and AI regulatory impacts, challenges, mistakes and readiness
What are the biggest regulatory
challenges for SaMD at the moment?
Tobias Schreiegg, Director Regulatory Affairs, Siemens Healthineers
"Diverging trends of different jurisdictions on requirements to, and qualification classification of SaMD. For one, different risk classes induce a different rigor of scrutiny. That of course depends, if your software is regulated or not. Here, manufacturers face fractured market definitions which can be a real hassle when going to markets beyond their own.
Essential principles are written to be applicable for all devices, including software. Some of them are hard to transpose for software, e.g. the ‘single fault condition’. Other challenges look on economic operators. This concept originates from the blue guide, where CE marked software was not in focus."
Petra Hoogendoorn, Researcher, National eHealth Living Lab
"Apart from the given introduction date late further guidance, lack of Notified Bodies and massive migration from class I to class IIa, I'd say the barriers it brings to SME's, while the EU has specified in the Digital Single Market transformation of health and care that it does want to facilitate SME's to participate in this market as well."
Jo-Ann Gonzales, Director In Vitro Diagnostics & Quality, and Mona Dean, Senior Consultant In Vitro Diagnostics & Quality, Precision for Medicine
"One of the most significant regulatory challenges for digital technologies is not having a well-established regulatory framework, and the pace of new technologies is exposing gaps in the current regulatory system. Regulatory bodies are challenged to develop a framework that will provide the least burdensome path to assess the safety and effectiveness of SaMDs that can support the rate of technological advancement.
Another regulatory challenge is the ability of the SaMD manufacturer to implement a quality management system (QMS) that will be useful throughout the SaMD’s lifecycle. This includes appropriate and timely risk assessment and well-structured verification and validation activities, including clinical evaluation, to ensure that the SaMD continues to meet safety and efficacy claims throughout its lifetime in the marketplace."
Nele Ooms, QA Manager, UgenTec
"The whole medical device industry currently agrees that compliance with MDR and IVDR for all products is the biggest regulatory challenge at the moment. This is not different for SaMD. However, I am also convinced that every change brings along new opportunities: MDR and IVDR force companies to optimise their current products, processes and documentation.
Software and AI can help companies standardize the way their products are being used in the field, reduce the training and support effort, and increase the reliability of the result. This creates a proven measurable process as well as a competitive edge."
Johan Ordish, Senior Policy Analyst (Law and Regulation), PHG Foundation
"One of the issues with the MDR/IVDR coming into force is that it’s often difficult to even get software and AI on the agenda. Indeed, much of the oxygen in the room (perhaps rightly so) is taken up the serious lack of Notified Body capacity, lack of guidance at the EU level, and Brexit uncertainty.
However, this means that the careful attention and debate that would otherwise be spent considering how new technology should be regulated is being spent elsewhere. In my eyes, the biggest challenge is having concrete plans for software and AI in the context of this uncertainty."
What impact will software and AI have
on the regulatory landscape for medical devices?
Johan Ordish, PHG Foundation
"Some AI algorithms pose special challenges for the medical device framework. For instance, black box models may find it difficult to link their model to established ground truth if we don’t know what the model finds significant. The MDR/IVDR and harmonised standards do not fully deal with this challenge. Moreover, adaptive algorithms retrain, they may be difficult to reconcile with change management processes. In responding to these challenges, it is important not to be exceptionalist. AI is not new, sometimes it offers new challenges for our regulatory framework but sometimes it represents a marginal improvement over and above hand-coded models."
Petra Hoogendoorn, National eHealth Living Lab
"Further standardisation and operationalisation, at least in the area I focus on in health apps."
Nele Ooms, UgenTec
"With an increasing understanding of molecular biology and focus on personalized medicine, the complexity of medical diagnosis, prognosis and therapeutics will only increase. Software and AI provide an opportunity to manage this complexity by providing the necessary information and context to the physician. Medical devices will therefore increasingly rely on software and AI as part of the system and the regulatory landscape will have to reflect this."
Tobias Schreiegg, Siemens Healthineers
"Some might call for a dedicated understanding of software as ‘in silico’ device. Besides raising the requirements on cyber security, AI as a technology field with all its methods exposes another dimension of variance in how to understand a product lifecycle and essential principles. Especially on ethical considerations of AI, and for medical devices, we should look on a by-sector approach as the systems are designed to help humans, not to kill them."
What are the common mistakes companies
are making with regulating their SaMD?
Jo-Ann Gonzales and Mona Dean, Precision for Medicine
"Common mistakes companies make with SaMD development are:
- Lack of fully characterized software development programs that can effectively manage numerous software iterations/updates.
- Poor understanding of the regulatory requirements for documentation from inception of the product through market adoption, thus creating a lack of traceability throughout the product lifecycle.
- Lack of personnel who are experienced both in software development and in the understanding of the clinical aspects for use of the software."
Tobias Schreiegg, Siemens Healthineers
"Being in touch with startups, I can say they start with the technology first, not with the intention of what problem to solve. They create
a powerful tool, or software, but then struggle with what its intended use should look like. Not to mention the following problems with clinical validation. Second, documentation requirements are highly underestimated."
"Being in touch with startups, I can say they start with the technology first, not with the intention of what problem to solve. They create a powerful tool, or software, but then struggle with what its intended use should look like."
Tobias Schreiegg, Siemens Healthineers
Petra Hoogendoorn, National eHealth Living Lab
"According to a piece of Dutch research many companies are not aware of it or else are aware of it, but do not taken appropriate steps. In a sample of 271 health apps, 21% proved to be medical devices, yet more than half did not have a CE-mark."
Nele Ooms, UgenTec
"A number of pitfalls for SaMD are addressed in the recent guidance for classification of SaMD, recently published by the European MDGC, such as the fact that not all software used in healthcare facilities is considered a MD. This MDGC guidance document also recognizes that nowadays software often consists of non-medical device and medical device modules. It is important that manufacturers clearly describe which part of the software is defined as SaMD.
For SaMD that is used in combination with other devices, it is important to define the intended use and the regulatory roles and responsibilities of all parties at an early stage in the development process, so that each party can take his responsibility into account during the course of the product development. Such a proactive approach prevents surprises or missing information at the time of regulatory submission."
"For SaMD that is used in combination with other devices, it is important to define the intended use and the regulatory roles and responsibilities of all parties at an early stage in the development process"
Nele Ooms, QA Manager, UgenTec
Are regulatory bodies ready to regulate
SaMD and AI? If not, why not?
Tobias Schreiegg, Siemens Healthineers
"SaMD has been in the market for quite some decades. And so has AI. It’s a matter of understanding that AI represents a vast field of technologies, which can be quite simple - such as decision trees, or complex - such as neural networks. We should respect that trained models are already out there. They do not necessarily change themselves without manufacturer interaction and exactly this aspect of continuity raises most questions.
I believe they are ready, but what matters most is to have all stakeholders on the same perspective looking at this field of technology. It’s practically worthless if manufacturers bring out new technology that is not adopted by healthcare providers because of the lack of trust in manufacturers and regulators."
Jo-Ann Gonzales and Mona Dean, Precision for Medicine
"Most of the regulatory bodies around the world have started several progressive initiatives to resolve gaps in the current regulatory landscape and to propose new strategies to address the rise of digital health technologies, but it will take several years before there is a concurrence on regulations between regulatory bodies and industry. FDA started the Software Precertification (Pre-Cert) Pilot program, which is intended to streamline the premarket notification process and shorten the overall review time. But time will tell if this process is worth the effort. Currently FDA is working with well-established companies to evaluate this program, and may not be able to address issues raised by smaller companies."
"Dialog between all stakeholders, regulators, industry and patients is very important to define a regulatory framework that works in practice and supports the launch of safe and effective innovative products."
Nele Ooms, UgenTec
Nele Ooms, UgenTec
"Until a year ago, I would have responded ‘no’ on this question, as it was hard to find any regulatory guidance documents on SaMD and AI. But over the last year, my opinion has changed. The European Commission recently submitted a guidance document on Classification of SaMD under the new MDR and IVDR. The FDA also published a discussion paper ‘Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)’ in April 2019 .
These efforts demonstrate that regulators do care about SaMD and they want to have a dialog with the industry about this topic. This dialog between all stakeholders, regulators, the industry and patients is very important to define a regulatory framework that works in practice and supports the launch of safe and effective innovative products on the market that allow improved treatment of patients. The fact that regulators are certainly embracing AI and providing pathways for use in therapies, diagnostics and sensors, can be seen by the exponential growing number of FDA approvals since 2015."
Johan Ordish, PHG Foundation
"The UK has new strategies in the works. There is a new regulator in the mix: NHSX. Regulatory bodies are working together to consider how the new world of digital health will look, how it will be regulated, and how existing regulatory frameworks may need to change. We’ve seen some of the fruits of this new collaborative spirit already but plans for SaMD and AI (as a medical device) in particular are yet to unfurl."
How will SaMD and AI impact patients?
Is this considered enough during reimbursement?
Tobias Schreiegg, Siemens Healthineers
"With millennials we all see and experience a change in usage of wearables and apps and the inherent expectation of ease of access and ease of use of this technology spans across all industries, from consumers to medical devices.
Digital Technologies will impact patients especially in the area of precision medicine. They allow easy collection and transmission of data and will be a key requirement for future technologies and special care needs to be taken for user-groups which do not interact as tightly with digital technologies.
Reimbursement is an interesting topic. We see Belgium, France and Germany moving forward to actively promote digital health technologies. Since health systems are a matter of EU member states, a friction can now already be seen. Such Digital Technologies, on a global basis, can only succeed if the results of assessments such as NICE are accepted worldwide. This would basically call for a convergence of separate health systems in that specific area."
Petra Hoogendoorn, National eHealth Living Lab
"My focus is in oncology and monitoring symptoms has proven to add 5-7 months survival and more quality of life, because clinicians are made aware of declines in functioning sooner, enabling them to intervene sooner, when the patient is still functioning relatively well. Worthwhile also from an efficiency point of view.
Again in my country [The Netherlands] 1 in 7 now work in healthcare. That is expected to be 1 in 4 by 2040 if nothing changes. We already can't find enough people now, we would not be able to afford 1 in 4 in healthcare and we need these people for other jobs as well. AI can be very promising, however does require an ethics by design approach to not harm or exclude patients."
Jo-Ann Gonzales and Mona Dean, Precision for Medicine
"Digital technologies (SaMD & Al) have significant potential to provide reliable data, early disease prediction, and prognosis evaluation, which can ultimately provide high-quality care to patients. It can empower patients to make informed decisions regarding their health.
Providers can monitor their patients much more closely and provide more actionable and better feedback. This will eventually help improve the relationship between the patient and healthcare provider."
Johan Ordish, PHG Foundation
"AI promises to change healthcare across the board. However, its impact upon patients depends upon where AI is introduced first and how it is introduced into practice.
In regards to where AI is being introduced, the sector picks low-hanging fruit first: automated image segmentation for radiological analysis, scheduling of appointments, and so on. Further, these initial uses will typically be assistive only: the system being a second reader or being used as a clinical decision support tool. Consequently, the near-term should bring appreciable impacts of quality and speed of service but not revolution in care.
In regards to how AI is introduced, predictive accuracy is often the primary measure of an AI’s performance. However, for use in healthcare, we should also focus on the system’s usability – are healthcare professionals able to contextualise the system’s outputs, can clinicians interpret what the model found significant and communicate a simplified explanation to their patient? Usability of systems – how the system integrates into practice will make a great deal of difference for patient satisfaction and quality of care."
Nele Ooms, UgenTec
"SaMD and AI are playing an increasingly key role in the accuracy and efficiency of diagnosis and treatment across various specializations. Reimbursement protocols currently do not sufficiently reflect this role. We believe that the move towards value based and outcome based healthcare will increase the adoption of SaMD to drive quality and efficiency across the health continuum."
MHealth in clinical trials: 79% of companies increasing usage
Data report analysis
KNect365 recently conducted one of the biggest surveys of its kind of clinical trial professionals asking about the most hyped areas of clinical trials today and whether they are actually impacting the way studies are run. 199 clinical trial professionals from pharma and biotechs (24%), CROs (23%), service providers (21%), consultancies (11%), sites (6%), academia (5%) and patient groups (2%) completed the survey, largely split between North America (55%) and Europe (33%).
A large section of the survey explored the perceptions, implementation, benefits and challenges of mHealth, AI and data technologies. Respondents made it clear that they think these are vital to the future of clinical trials, with 53% placing mHealth or AI as having the biggest impact on clinical trials by 2030. Here we dive into this data to pick out key trends of where the industry is currently at and where it is going with the technology revolution in clinical trials.
Implementing mHealth technologies
MHealth technologies are increasingly changing the way clinical trials are run and this is backed up by 79% of respondents who said it was ‘Likely’ or ‘Very Likely’ their company will increase its use of mHealth in the next two years.
However, clinical trials professionals clearly think there is still a lot of work to be done with current integration of this technology. When asked to rate how well their company is currently implementing mHealth technologies on a scale of 1-10 (1 being ‘not at all well’ and 10 being ‘perfectly’), the average score was just 5.69/10. Furthermore, 11% of respondents gave the lowest score of 1/10 in how well their company is implementing mHealth technologies, versus just 3% who said their company was implementing mHealth perfectly.
Interestingly, a split was seen between corporate management respondents who gave an average rating of 6.43 and those working in clinical operations who averaged just 4.89. Also, perhaps unsurprisingly, respondents from service providers and medical device companies feel they are implementing these technologies better than pharma and biotech companies with an average of 6.09 versus 4.91, with CROs sitting in between the two on 5.49.
Of those currently implementing mHealth, mobile apps were the most common form of technology with 56% of respondents, followed by monitoring devices (40%) and activity trackers (30%). Other responses included ePRO, mECG, sleep measurement, voice-based technology, time and date stamp medicine adherence, eLabel, SMS reminders, video observation and “multi-modal communications tailored to patients' preferences”.
Which mHealth technologies has your company used in clinical trials?
The benefits and challenges of mHealth technologies
There are a variety of potential benefits to using mHealth technologies, but the majority of respondents focused on data generation as the primary advantage, with 42% citing real-time data acquisition and a further 30% on improved data quality.
With the proliferation of clinical data generated by new technologies, it can often seem that companies are drowning in Big Data. However, our survey respondents suggested that in general companies are managing and utilising the data well – giving an average score of 7.27 when asked to rank out of 10.
What is the primary benefit derived from use of mHealth technologies?
On the other side of things, when asked about the primary concern around mHealth, answers were split quite evenly between difficultly in implementation (28%), data security (27%) and patient or physician resistance (20%).
What is your primary concern with the use of mHealth technologies?
Whilst respondents were happy to choose one of the provided options for the benefits of mHealth tech, it is telling that they were far more vocal when given the opportunity to discuss concerns. Answers included:
- “Lack of data standards used by mHealth companies to help integrate data with a central database.”
- “Unless you nail the patient to the floor there will ALWAYS be problems with the use of more and more intricate and involved e-technologies that will result in bad or skewed data, or bad relations with clinicians / sites and the sponsor, who puts it on the consultant to 'correct' somehow.”
- “Organizational resistance”
- “Systems don't work well. Poor design.”
- "Slow industry adoption”
- “Sponsors all have different methods for using such technologies. What must be understood is that they don't always work or there are difficulties implementing them with patients. Computerised methods look great on paper, but when they just don't work because patients are unable to utilise them appropriately, crucial data is not collected and this causes no end of difficulties for site staff trying to collect this data. Some of these technologies are just too complicated and 'iffy' to work in all instances.”
- “Cost”
- “Ease of use for the patient.”
- “Increased time the site has to spend training employees and patients on the tool; troubleshooting and monitoring the compliance of the subject.”
- “When data is not 'optimal', sponsors then pressure consultants and clinical staff to 'make' it work, often causing friction between all parties resulting in ongoing bad feeling.”
It’s clear that there are still a number of concerns with the adoption of mHealth, yet the importance of the varying technologies to clinical trials isn’t in doubt. In the report introduction, Citeline succinctly sums up the industry’s perception:
Despite difficulties in incorporating mHealth into trials as well as data security, evidence supporting adoption of mHealth products, such as mobile apps and activity trackers, continues to grow, paving the way for this technology to realize key benefits, including real-time data acquisition and improved data quality.
Citeline
Low literacy issues and the Patient Information Leaflet
THE AVERAGE READING AGE 0F ADULTS IN THE UK IS THAT OF AN ELEVEN YEAR OLD
This alarming statistic has a dramatic impact on patient engagement in clinical trials. Clinical trials have become increasingly complex, involving more procedures and collecting data using different technologies. A recent survey by KNect365 found trial complexity was felt to be the biggest challenge facing clinical trial professionals, so how much more does this impact on patients and their willingness to participate in a trial? Low health literacy is now widely recognised, but this issue cannot be tackled until low literacy has been addressed.
Part of the patient recruitment process is ensuring that a patient fully understands all aspects of the trial to enable them to comply with the requirements. To support this, they are provided with the Patient Information Leaflet (PIL), however, these documents are lengthy, use technical terms and can be intimidating. Patients are reluctant to admit that they do not understand the information and the easier option is to not be involved.
How can we change this?
The first step is to simplify the process. Ensure that sites are provided with a letter to send to potential recruits informing them that they may be eligible to take part in a study and some basic information about what is involved, in language easy to understand. This needs to include a reply slip for patients to enter their contact information. A telephone call prior to sending this out enables the site to initiate a relationship with patient and personalise communication. If this call can come from someone that they are already familiar with at the Practice this helps to reassure the person. This also enables them to expect the letter and increases the likelihood of a response.
A face to face discussion about the trial enables the research team to use a language format that the patient can easily understand. One method I used was to invite potential participants in for a group talk with myself and an investigator. The doctor would give some information about the condition and current treatment options, I would explain what being in a trial involved and the investigator then would discuss some of the specifics of the study. I would try to have a patient involved who had previously taken part in a trial to give that perspective. At the end of the talk we would book a one to one appointment for those that were interested, and give out the Patient Information Leaflet. The whole session was relaxed and informal with plenty of tea and coffee. I wanted those attending to feel comfortable and be able to ask questions. Family members were welcome as we were aware that often it was their fears that deterred patients from enrolling in a trial.
Olivia Neely at Dr Ainsworth’s site in Leamington has a similar approach. She will often invite patients in to talk about the trial three or four times prior to signing Informed Consent to ensure that they feel fully informed and comfortable with all aspects of the trial. This results in a high retention rate and compliance with the Protocol. She likens this to decorating – the more time spent in preparation, the better the outcome!
However, these talks and visits are often not included in the costings for the study. Experienced site staff recognise the value of dedicating this time to ensure the best outcome for both patients and Sponsors. Perhaps it is time that this knowledge is recognised, and funding is allocated to recompense the time spent in preparation. After all, sites with a high retention rate ultimately lower the cost to the Sponsor.
What can Sponsors do?
Sponsors could also help sites by providing the Patient Information Leaflet in a more acceptable format to patients. Provide the information in smaller chunks, perhaps enable sites to tailor this to the patients’ requirements. As an example, often there is a whole page focussing on pregnancy, this could be removed for post-menopausal women or men. More care needs to be taken with how the information around side effects is communicated. Regularly patients told me that they didn’t want to take part because of getting ALL these problems. At an appointment I was able to reassure them that they were highly unlikely to have all these problems and may not experience any side effects. I used a Patient Information Leaflet for Paracetamol to demonstrate the requirement of informing those taking a product of possible side effects. Listing pancreatitis and hepatitis did not mean that all patients would be afflicted if they took Paracetamol. However, I was unable to do this for those patients receiving the PIL by post, or for their family members.
As an industry it is easy for familiarity with what we do to cause us to become blasé about the understanding of those outside the profession. Employing a specialist company to design information leaflets with low literacy in mind is one solution, another is to involve patients in providing feedback. A trap companies fall into is using “professional” patients which then distorts the relevance of their contribution.
It is recognised that literacy and numeracy issues affect a patient’s ability to comply with routine appointments, planning journeys to arrive at the correct time and generally understanding what is required of them. Assistance with this is vital, not only providing reimbursement for taxi costs, but booking the transport and confirming this with the patient. Most patients find text appointment reminders useful. These could also include prompts to fast prior to their appointment, return IMP, return diaries etc. However, all this takes up more of the sites’ time so the Sponsor could consider using a company that provides a concierge service to relieve this burden.
The ethics of patient consent in clinical trials - Dr Kieran Doran, Senior Healthcare Ethics lecturer at University College Cork, argues that one of the current big failings of patient-centricity in clinical trials is patient consent.
Six ways to improve patient understanding
- Ensure all language used is low literacy compatible
- Provide information in smaller, easy to digest sections
- Recognise and reward sites that are committing extra time, visits, phone calls to ensure full patient understanding
- Utilise specialist companies to design the PIL
- Enable sites to tailor the PIL to individual needs
- Employ a concierge service to aid appointment attendance as per Protocol
