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  • Writer's picturechibbye
    • Jun 7, 2021
    • 7 min read

Are Decentralised Clinical Trials Driving More Patient Centric Site Feasibility?



I think it’s fair to say that the Pharma R&D world is hypnotised by Decentralised Clinical Trials (DCT) at the moment. While it’s challenging to define DCT, it can be described as trials that are carried out through telemedicine and mobile or local healthcare providers, leveraging processes and technologies that are different to the traditional clinical trial model which is heavily focussed around the ‘site’ (the specific hospital or clinic selected by a pharmaceutical (Pharma) company or Contract Research Organisation (CRO)). For me and many of my peers, DCT represents providing more possibilities and options for people participating in clinical trials. While DCT isn’t a new concept, the forced acceleration of decentralisation of clinical trials during the pandemic has presented plenty of opportunity for a makeover of many of our existing processes, and fortunately site feasibility has also undergone a reformation.


For many years site feasibility (the process of assessing the possibility of running a particular clinical trial at a specific hospital or clinic (the ‘site’) has maintained persistent challenges. By definition, Site Feasibility is the evaluation of clinical trial sites by a Pharma company or CRO. The objective is to determine their ability to accomplish certain clinical study success criteria; specifically, conducting and completing the trial within budget and timelines, achieving patient recruitment targets, and generating high quality data. As an industry we’ve endured endless discussions about the problems, perils and perfunctory nature of existing site feasibility processes. From the Pharma/CRO perspective, processes are stagnant and inefficient, and predicting site performance and mitigating site-related risks to study conduct has been consistently difficult. For the sites, the processes and methods bestowed on them by Pharma/CROs are still burdensome, outdated and assume that ‘one size fits all’, neglecting the fact that their closeness to patients means they require options and flexibility. All of this has led to disappointing metrics that have barely changed over the years: 37% of sites under enrol patients, 11% of sites fail to enrol a single patient, and of 89% sites will reach enrolment targets only once the study timelines have doubled. As a result, approximately 80% of clinical trials are delayed due to poor patient recruitment. Ineffective and unproductive site feasibility processes have a significant influence on these numbers.


Working in this space over the years, I have explored different practices, strategies and solutions to solve the site feasibility puzzle, working with and within companies to attempt to redefine the process before realising that the industry’s approach towards site selection has made these challenges somewhat systemic, thus requiring a complete overhaul. More importantly, an overhaul that needs to go back to what or should I say who is at the heart of the trial…the patients.


During the pandemic, patients’ willingness to go to central clinics for treatment or monitoring declined significantly with a heightened fear of COVID infection. This was one of the primary reasons for many companies shifting their clinical trial delivery model from being centred around the clinic to be more patient-focused. With this development, the Key Performance Indicators that our industry measures itself to are evolving, and the experience and perception of the patient is becoming a critical performance measurement that directly impacts the evaluation and selection of clinical trial sites.


Let’s talk site feasibility surveys! A site feasibility survey or questionnaire is a set of questions prepared by study teams (at Pharma or CRO company) asked to staff at clinical trial sites to determine their interest and suitability for a particular study. Feasibility survey questions primarily focus on site facilities and infrastructure, site staff experience and availability, and whether the staff have been adequately trained. Questions about perceived regulatory challenges and site start-up timelines are also standard. For most of us, the most critical aspects of the feasibility assessment are the questions that appraise a site’s engagement with patients. Typically, the questions around patients have an emphasis on the number of appropriate patients in a site's database and how many they estimate they can recruit from that pool. I don’t think we have paid enough attention to many other crucial considerations of the site-patient rapport and the overall patient experience.


While it seems obvious to simply ask better questions, most companies have continued with their existing site feasibility style, however ungainly or unsatisfactory, until the acceleration of decentralised clinical trials! The COVID pandemic-driven-quickening of moving from “site-centric” trials to “patient-centric” trials has given us the opportunity to do a complete renovation of the box-ticking, cursory-style questioning and reimagine site feasibility surveys through a patient-centric lens. So, how is this being done? Well, it starts with adding depth to inquiries about the site’s access to patients and whether they have the infrastructure to support and enhance their trial experience. Of course, number of patients within a clinic’s database and the site facilities is important information, but that information becomes more useful when it is framed with an understanding of the site-patient relationship, a couple of examples are:


  • How broad is the patient population that the site has access to?

With the rise of decentralised trials, there is an opportunity for Pharma companies to achieve more diverse recruitment and reach broader geographies. Consequently, ascertaining a site’s ability to access a wider range of patients, even those that do not live in close proximity to the site location, is now a necessary assessment. With this, we have to understand whether the site has the appropriate digital capabilities and readiness to support and maintain an expanded patient and healthcare provider network.


  • Does the site have capability/experience with supporting diverse patients?

Clinical trial diversity goes beyond access to diverse populations - it includes the ability to adequately support the needs of different patient populations, in order to engage and retain them on a trial. Recent data has shown that some of the top-rated hospitals in the United States are falling short with respect to racial inclusion and diversity. I also recently read about a study in Europe that revealed there hasn’t been enough focus on the training needs of healthcare workers serving the LGBTQ+ community. It’s widely known that a significant barrier to trial participation for diverse populations is their lack of trust in healthcare and Pharma companies. As a black African in the UK, discussions with family and friends from similar backgrounds about their experiences with healthcare services has highlighted a lack of cultural awareness and sensitivity from healthcare professionals. This experience is amplified in clinical trials where there is heightened cautiousness from potential trial participants. It therefore becomes a necessity to determine whether site staff have received adequate training to support inclusive and diverse patient populations.


In addition to understanding the site-patient relationship, it’s important to ask the site more contextual information about patients that could inform the study execution strategy:


  • What information does the site have about patients and technology adoption?

Technology accessibility and proficiency of patients within a site’s database is being queried more (largely driven by the pandemic, as this is a critical implication to decentralised trial strategies). The sites that have the ability to track whether patients have smartphones, or provide insight into the proportion of patients who are comfortable using technology can indicate how likely or easy it is for patients to participate in virtual visits or use digital applications for consent or Patient Reported Outcomes.


  • Is the Pharma company’s protocol design executable from the site’s viewpoint?

In clinical development, a clinical trial protocol is a document describing how a clinical trial will be conducted including the study purpose, design, methodology, statistical considerations and organisation of the trial. Strangely, feasibility surveys have more content asking sites whether they have a -70-degree freezer instead of whether they think the protocol design is viable from their perspective and experience with patients. Additionally, many organisations still wait until they have developed their final protocol before planning for feasibility and obtaining the site’s input. Designing a protocol and identifying and selecting the right sites should run in parallel. For example, it’s necessary that Pharma companies and sites (and patients of course) collaboratively develop and assess the practicality and achievability of the patient inclusion and exclusion criteria, to make sure protocol complexity and patient burden is minimised where possible, ultimately boosting patient recruitment and enablement.


In summary, decentralised clinical trials have highlighted the need to move away from the industry status quo with haste and innovate faster. It’s great to see some of that quickened innovation being realised in the site feasibility process by recognising that the data obtained from site feasibility requires more depth around the patient experience. As I said in my blog post What’s More Personal Than Health?: “We all love data, but true patient centricity recognises the need to make data more about the person”. This attitude very much applies to site feasibility and selection. Although we’re all entranced by decentralised trials at the moment, our next steps should be to explore more strategies to reform site feasibility beyond what’s needed for decentralised trials. Our mission should be to continue removing wasteful steps and stop collecting non-critical data, but rather focus on optimising site feasibility in a patient-centric manner, to improve patient access to clinical trials and speed to new treatments.


References:


Clinical Trials Transformation Initiative. CTTI Recommendations: Decentralized Clinical Trials. CTTI White Paper. 2018. Available at: https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf. Accessed June 3, 2021.


TRIALFACTS. Data Doesn’t Lie: Clinical Trials Enrollment Forecasting – Is It Worth It?. Trialfacts.com. 2018. Available at: https://trialfacts.com/data-doesnt-lie-part-l-clinical-trials-enrollment-forecasting-worth-it/. Accessed June 1, 2021.


Willis, R.C. Special Report on Clinical Trials: Delving into decentralization. Drug Discovery News. 2021. Available at: https://www.drugdiscoverynews.com/special-report-on-clinical-trials-delving-into-decentralization-15044. Accessed June 1, 2021.

Ford, M. Europe’s nurses need more training to ‘reduce biases’ around LGBT+ issues. Nursing Times. 2021. Available at: https://www.nursingtimes.net/news/research-and-innovation/europes-nurses-need-more-training-to-reduce-biases-around-lgbt-issues-03-03-2021/. Accessed June 2, 2021.


University of California San Francisco. Clinical Trial Protocol Development. Clinical Research Resource HUB. 2017. Available at: https://hub.ucsf.edu/protocol-development#:~:text=The%20protocol%20is%20a%20document,integrity%20of%20the%20data%20collected. Accessed June 3, 2021.


Miesta, E. Bayer Overhauls Its Clinical Trial Planning Process. Clinical Leader. 2020. Available at: https://www.clinicalleader.com/doc/bayer-overhauls-its-clinical-trial-planning-process-0001. Accessed June 1, 2021.




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  • Writer's picturechibbye
    • Feb 26, 2021
    • 4 min read

What's More Personal Than Health?


Now more than ever, largely due to COVID-19, Pharmaceutical Research & Development has an amazing opportunity to dissolve the public perception of ‘Big Bad Pharma’. How can we seize this opportunity and demonstrate that our goal has been and always will be to bring novel treatments to patients faster? I believe transforming clinical trials into personalised engagement experiences while leveraging digital technologies is a critical path forward, but how we leverage those technologies is even more critical.


Who doesn’t love a personalised experience? Retail, banking, streaming services and many other industries have established a phenomenal precedent for personalised experiences, all centred around the notion of customer-centricity. Customer-centricity is why I’m addicted to monitoring my fitness progress on apps like Map My Run and why Amazon parcels are constantly being delivered to my front door. Patient-centricity, similarly to customer-centricity, is a concept that has been around for a while. In my opinion, the primary difference between the two is that while other industries have truly grasped and engaged with customer-centricity, the term ‘patient-centricity’ has felt more like a trend rather than a true practice until very recently. In my last blog post (‘The Pharma Bubble’), I said ‘Pharma does not own drug development…we enable it and partner with patients to drive it’. Fortunately, the evolution of patient-centricity is full of promise as we are now recognising the power of this partnership. We’re working towards empowering patients to own their clinical trial experience and it’s about time because what’s more personal than health?


For us digital innovators seeking to improve clinical trial data quality, one of our biggest challenges is bi-directionality. How do we improve clinical trial data quality and arm clinical trial teams with the ability to explore outcomes, but also empower patients to be and feel like the centre of everything we do? How do we personalise their experience?

I’m thrilled that mobile health (mHealth) and real-world data (RWD) are becoming primary facilitators for effectuating patient-centricity. However, as an industry with a hunger for data plus more data, we have a tendency at times to forget that patients are not just data points. Impersonal data-driven assumptions are certainly essential, but we must hear their voices authentically to give the best trial experience for optimised trial outcomes and improved health outcomes.


So how do we make that shift towards viewing and utilising data and digital technologies as mechanisms to actively listen to people’s wants and needs authentically and truly adopt patient-centricity? Let’s talk about trial design for a moment. Several aspects of a clinical trial are unpredictable; therefore, we need all the robust data we can get to ensure we design a protocol that leads to predictable study delivery within timelines and within budget. Recruiting patients is often the most unpredictable step as well as the most critical, which is why patient involvement in designing a study is pertinent for a successful outcome. The industry as a whole has made considerable improvements to ensure we engage with patients at the earliest stages of program and protocol design in the last 5 years. However, in my view, study design optimisation activities are still often disproportionately focussed on using RWD to model cost and time variants, rather than listening to what works for the patient on a personal level. ‘But we love data!’ I hear you say. Well, I’m with you there. So why don’t we convert what we hear directly from the patient about their personal inclinations, circumstances, drivers and unmet needs into quantifiable data? We all love data, but true patient centricity recognises the need to make data more about the person.


A human-centred approach to data and quantification of human measures will allow us to design and conduct research with a sensitivity that perhaps has been missing in the past. I’ve said before that people are more than just patients. They have families, they have jobs, they have social lives, they have responsibilities, they’re part of a community. A very topical example is cultural sensitivities towards certain groups and subpopulations, which of course resonates strongly with me. Racial and ethnic minorities are considerably less likely than our white counterparts to be included in research, even when certain health conditions disproportionately affect our communities. Fortunately, many emerging innovations show huge potential to address some of the inequalities in clinical research, specifically mHealth which covers wearable sensors, mobile devices and other online or digital services which may be more basic in nature (e.g., social media). The broad accessibility of these tools could inherently enable more inclusive study participation. Of course, this sounds promising, but without the authenticity of actively listening to the human experiences, there is actually a risk of discriminatory profiling or ‘targeting’ ethnic minorities for clinical trials, which is anything but sensitive and less about personalisation. Personalisation means understanding what someone wants and needs and translating that into measurable evidence to improve and enhance their lives.

Our comprehension of patient-centricity is evolving. As we realise it’s more than just a moment and no longer just a trend, the practice of it is critical. As standard practice in digital innovation, we must develop and enhance technologies through the lens of the patients. Whether it’s solutions that put patients at the heart of trial design to improve the likelihood of enrolment, or conceptualising different humanised methods for consenting and recruiting patients; it’s all about making it more personal because what’s more personal than health?


References:


Neuer, A. Patient Centricity and Virtualizing Technologies in a COVID-19 World. SCRS White Paper. 2020. Available at https://vertassets.blob.core.windows.net/download/7e2fa92c/7e2fa92c-e04f-49df-8fd5-f924349e9575/patient_centricity_white_paper_w_scrs__dec_20_.pdf. Accessed February 19, 2021.


Covington, M.T. Digital health Innovation: The Predictive Impact of Curated Real-World Data In Times Of Change. Clinical Leader. 2020. Availavble at https://www.clinicalleader.com/doc/digital-health-innovation-the-predictive-impact-of-curated-real-world-data-in-times-of-change-0001. Accessed February 19, 2021.



Cleary, M. How mHealth Technology is Revolutionizing Clinical Research. Value and Outcomes Spotlight. 2018. Available at https://www.ispor.org/docs/default-source/publications/value-outcomes-spotlight/september-october-2018/ispor-vos-october-2018-toc-mhealth.pdf?sfvrsn=5822a619_2. Accessed February 19, 2021.


Callier, S. and Fullerton. S.M. Diversity and Inclusion in Unregulated mHealth Research: Addressing the Risks. Journal of Law, Medicine & Ethics. 2020. Available at https://journals.sagepub.com/doi/10.1177/1073110520917036. Accessed February 19, 2021.


Chen, J., Mullins, C.D., Novak, P., and Thomas, S.B. Personalized Strategies to Activate and Empower Patients in Health Care and Reduce Health Disparities. Health Education & Behaviour. 2015. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4681678/. Accessed February 19, 2021.





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  • Writer's picturechibbye
    • Jan 19, 2021
    • 6 min read

The 'Pharma Bubble': Are We Out of Touch with the Real World?

Updated: Jan 20, 2021


It’s January 2021 and it has become difficult to remember what life was like before the global pandemic, and more importantly, we have been forced to accept that life will not return to ‘normal’, for a while yet. The impact to humanity has sent the world into unfortunate chaos and tragedy, while simultaneously highlighting trends and views that we previously did not pay much attention to. Perhaps the most mesmeric consequences for me are a) how everybody is fixated on drug development whether good or bad, and b) the unveiling of the perceptions people hold of the Pharmaceutical (Pharma) industry.


As a Pharmaceutical Research & Development (R&D) professional, I have been fascinated by the opinions shared on social media, in articles, and even by friends and family when it comes to healthcare. One of the most prominent observations that I’ve made is that it’s like the world is looking at drug development and the Healthcare industries for a solution, but they don’t necessarily trust what they’re being told. These industries are constantly battling conspiracy theories and severe mistrust. They’re not necessarily making the connection they need to make with the real world, and it begs the question ‘is Pharma out of touch?’


Here’s my first thought: is the Pharma industry like a bubble, finding itself enclosed and at times isolated from the reality of the outside world? If so, this poses a critical issue when the work of drug development is intended to serve the world outside the ‘bubble’. Take the recent news of the success and subsequent roll-out of the Pfizer/BioNTech, Oxford-AstraZeneca and Moderna COVID vaccines, the Research and Development community has been overjoyed. However, when you listen to the opinions of family and friends external to that community, or perhaps observe comments on social media platforms (Twitter, Instagram or Facebook), many do not align with our enthusiasm. Comments doubting the credibility and intent of ‘The Vaccine’ are unfortunately quite frequent and that’s before the flood gates of hesitancy and reservations are open (with VERY good reason), as it pertains to the People of Colour (POC) and Black And Minority Ethnic (BAME) communities. For these communities, the sentiment and expression of mistrust is much greater. The dark history of medical experimentation in Africa and the horror of the Tuskegee Syphilis Study, albeit in the past, are still scary examples of racially driven unethical practices. Additionally, it’s not convincing enough for the vaccine to be rolled out widely, as proven and persistent racial health disparities cause constant clouds of doubt.


In the era of COVID, as someone who is wedged between the Pharma Bubble and living in modern day society as a Black woman myself, my reflections on patient, people or public engagement have highlighted some key questions:


1. Do we know what clinical research means to the public? Many people have very little idea of how trials work nor why we need them, much less view them in any type of positive light. That’s quite worrying, but not surprising. The terms and definitions of our domain are so familiar to us, that we neglect to speak in a language that others can respond to. This leads to miscommunication and misinformation. Education on clinical trials is only prioritised when we want to engage patients, but I think that’s far too late, and it’s a crucial factor in our struggle with patient engagement and recruitment. Our ambition should be to boost patient education in healthcare beyond clinical research. Consequently, this will improve health outcomes, as people will be better informed to make suitable health decisions, thus enhancing how they manage disease and treatment. In turn, people will begin to recognise clinical trials as a viable care option, becoming willing (and perhaps excited) participants in research, wanting to advance drug development.


2. Are our approaches to engaging with the public motivated by us thinking of them as patients rather than people? Many patient engagement strategies are focused on bringing patients to our world, rather than evolving our comprehension of what happens in theirs. From an operational perspective, we focus heavily on return on investment (ROI) and miss the opportunity to truly understand people’s needs and how to convert that into a measurable ROI. Other times, we attempt a ‘one size fits all’ approach. A perfect example of this is how diversity and inclusion in clinical trials is being addressed. Following the FDA guidance to enhance the diversity of participants in clinical trial populations, many organisations are charging ahead with efforts to comply with this guidance. I’ve sat in many conversations discussing how to reach minority patients where minorities are discussed as though they are a monolithic group. There isn’t a magic formula or specific method to get you minority patients in clinical trials and going down this path will only amplify the message that ‘Pharma doesn’t get it’. Understanding them as people rather than potential patients will lead to better apprehension of diversities, disparities, and underprivileges, shifting our focus to developing a genuine relationship of trust and inclusion. Following that, the diversification of the patient population in clinical trials becomes the natural outcome.


3. Lastly, and perhaps the overarching theme to my other observations: have our methods expired? We live in a time where behaviours and choices are influenced by what we follow and what we consume. Personally, I engage more with content that appeals to who I am as person. Does it appeal to the interests of my age group? Does it appeal to my experiences as a woman? Does it appeal to my experiences as a Black woman? Now more than ever, we’re witnessing industries becoming more creative and innovative with initiatives to engage their target audience. Spotify learns my listening preferences and suggests new music for me to try; would it not be awesome if we could do that to address unmet need? Amazon knows I like to read books by African authors and gives me some great reading suggestions; could we reach that level of maturity to understand a patient’s journey and provide them education materials. Could we learn to use Instagram and YouTube the way Social Media Influencers do to engage people? In our ‘Pharma Bubble’, we tend to recycle old approaches. We’re trying to make old techniques work, and not learning from people’s behaviours and motivators in the way other leading industries have, leaving us stuck trying to captivate an audience who aren’t really interested anymore. Too often I hear ‘that’s not how it works in Pharma’, to which I respond ‘but, that’s how it works in real life’. We all know our industry is highly regulated, and the nature of what we do requires us to work within guidelines and parameters that other industries are not challenged by, but the current times have reinforced that we NEED to modernise.


It’s time we burst our Pharma Bubble; people are more than patients. We need to address the growing chasm between our community and the outside world. One could argue that people will always need drugs and treatments, regardless of our approach. My argument is that we don’t own drug development, it’s a shared responsibility with the public. We enable it and partner with patients to drive it. Therefore, the speed and quality at which we can deliver novel treatments to people requires a greater responsibility on our part to reimagine and revolutionise our approach, diversify and expand our engagement, and empower the patients.



References:


Turda, M. (2007). Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Oxford: Social History of Medicine, Pg 1


Scharff, D.P., Mathews, K.J., Jackson, P., Hoffsuemmer, J., Martin, E. (2010). More than Tuskegee: Understanding Mistrust about Research Participation, J Health Care Poor Underserved, Pg 1


Harris, S.M. and Kelly, C.G. (2016). Patient Education in Clinical Trials and Throughout the Product Lifecycle. Reading: Medical Education, Pgs 1,2,3.


FDA Guidance Document (2020). Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. FDA.gov.


Kelly, S. (2013). Testing Drugs on the Developing World. British Columbia: The Atlantic, Pg 1


Mastroianni, B. (2020). Why Some Black and Latinx People Are Reluctant to Get the COVID-19 Vaccine. Healthline.com, Pg 1


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