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Patients, People and Holistic Stakeholder Engagement

Sally Tucker, Head of EU Operations, UK Site Head

I recently attended the 4th Annual Patients as Partners Europe event in London where I had the opportunity of listening to patient advocacy groups, patient engagement personnel within industry, the patients themselves and industry partners. I would like to start by first thanking the organisers of this insightful event with special mention to the patients involved who so openly shared their experiences with us all – Al, Matt and Lesley, I applaud and thank you. You were heard and we should all strive to do better.

As members of the healthcare community, patients stand at the centre of what we all do. On a personal level, throughout my career, I have held my commitments to patients in high regard and upon joining Ora I considered how we could bring further value to the patients we serve.  Prior to attending this conference, I would have confidently told anyone who cared to listen, with self-assurance that I indeed, do engage with patients and have done so throughout my career. However, I came away from this insightful conference questioning just how effectively I have done this to date, with a heightened desire to do better.

Traditionally patients in clinical trials do not get the opportunity to provide input to protocol design, assessments or visit schedule, and their involvement most commonly begins at the time of consent when they are presented with a patient information sheet to determine their desire to be involved.  There is a greater calling that this should change, with patients having the opportunity to provide added value to the clinical trial activities they are so well-equipped to provide. Regulatory authorities and governing bodies, with increasing frequency, are encouraging and requesting more patient interaction. Rather than making this a “check the box” exercise, we should embrace the goal to optimise this interaction and assist in developing clinical programs that aid recruitment, retention and meaningful data collection for the patient. Having worked in both a primary and secondary care setting, with multiple pharmaceutical/biotech companies and now a CRO, I have seen first-hand how industry and medical stakeholders are so well engaged in the protocol development stage. We should consider however that the true expert in the disease, in real life terms, is the patient and as such their opinion matters greatly. The appropriate patient involvement could result in studies that are more meaningful, pragmatic and attractive to the patient. These, in turn would likely aid recruitment, increase retention and result in the more timely completion of studies.

There are several thought-provoking take home points I walked away with from this 2-day event that I would like to share:

Meaningful versus measurable

Study endpoints are generally quantifiable measures, some of which are traditional and expected, but perhaps are not as meaningful (or qualitative) as we think to the patient. We should consider providing greater emphasis on what matters to the patient and determine what endpoints would impact them the most. We cannot underestimate the value a therapy may have on a patient’s quality of life, and if not considered as part of the clinical design process it could be missed. This could result in the inability to make claims that the patient and health technology agencies (HTA) could relate to, and these could be endpoints that are valued far higher to the patient than the traditional more quantifiable measures.  Of course, as with everything in life there needs to be a balance, but how efficacy/effectiveness is determined can be crucial to the life cycle of any potential treatment modality. I believe that with input from the patient together with guidance from regulators, HTA’s and doctors, careful endpoint determination could aid increased sensitivity and specificity to highlight meaningful differences that could positively impact those living with the condition under investigation.

Communicate with and involve the Patient

The patient gives so much to any clinical trial: their time, their data and their input. They also face logistical and financial burdens that are not always fully appreciated. So, what do we give back to the patient, the people who are so pivotal in all we do and without whom we have nothing?

We all know that communication is crucial, and we also know how our industry loves the use of acronyms and terminology that to the lay person can cause confusion and result in misunderstanding. It is easy for us, as members of industry, to desensitise the condition the patient is living with, the modality of treatment and for us to somewhat dehumanise the patient. The involvement of patients in study planning would ensure that we eliminate the unnecessary use of jargon from patient-facing materials and that all the information is presented in a factual but sensitive manner. Utilisation of the patient can also ensure the study design is not too burdensome and help us to appreciate the logistical difficulties the patients may face and how we can adapt trial design to optimise compliance and continued engagement.

We also need to take the path of continued improvement. We live in a changing world and as such the way in which we conduct trials should also change to reflect this. The introduction of adaptive and virtual trials and mixed method trials are indicative of these needs and we should consult with our patients after studies complete to get their feedback and thoughts. We can use this to improve the service we give them, from a protocol design and delivery perspective but also from a site level perspective.

Finally, we must always remember that the data we collect is that of the patients and belongs to them. They provide this so we can offer solutions that potentially have positive impacts upon them and other individuals with the same conditions. We should always provide 360 feedback to the patient to enhance relations between parties and to highlight the importance of their involvement. In this way we can promote research, its value and highlight how these clinical trials can benefit the community.

More thought to patient carers

“Being in a clinical trial is lonely” – this is a quote a patient shared. You are on a journey by yourself. The drug, by default, is investigational and as such the patients embark on a journey not experienced by many. They have no one to discuss this with because the experience is unique to them, yet they are supported every step of the way by their caregivers who provide support that is critical to help them “keep going”, “not give up” and provide “a reason to go on”.

We need to do more to acknowledge these people who provide the support, perhaps by gathering their input and objective assessments and including them when we engage with patients.

In summary, we need to remember that patients are at the centre of all we do. We should optimise the way we engage, listen to and involve patients in the development, design and delivery of the clinical studies we conduct. We should consider carefully the human element to every aspect of the trials we conduct and ensure the needs of the patient are met.

What stood out to me more than anything during this conference is that we all want to do more. A quote that was shared during the event that resonated with me: “If we want to go fast, go alone, if we want to go far, go together” and this is true of patient advocacy and engagement. Involving more people takes more time and effort, however in doing so it could result in greater efficiencies from a product development, time, recruitment and end goal perspective. Listening to my peers at this event, I know we all want to find ways to optimise how we engage with patients, the people who we ultimately want to impact in a positive way! There is so much we can do to foster this collaboration to benefit industry, clinical sites and patients so we can speed the time of delivery and provide more meaningful results to the community as a whole whilst improving the patient journey. This will take time to accomplish, being an evolution rather than a revolution.

About the Author

Sally Tucker is the Head of EU Operations and UK Site Head at Ora. She is an optometrist with a PhD in ophthalmology and has more than 20 years of experience in eye care and over 15 years within the industry. She has held positions in marketing, training and education, and clinical for global pharmaceutical and medical device companies. Sally leads the focus on building a high-quality, expert, and efficient clinical operations team within Europe. She brings her dedication to quality assured outcomes, clinical excellence and accreditation, sound process development, regulatory compliance, and project excellence to growing and expanding Ora’s global presence.