Throwing Light on Clinical Trials

Sally Tucker, whose career in ophthalmology spans 25 years, has worked in the ophthalmic industry since 2003. She is now Vice President of Ora Europe, heading up the organization’s European operations.

In this interview, she discusses Ora’s history and current activities. She explains why it’s important to ensure straightforward clinical trial access for patients with ocular disorders and why awareness of past, current, and future research benefits ophthalmic patients, and the field.

Tucker explores the gaps in bringing patients to relevant trials and vice versa, discussing ways in which Ora can help address these issues. She explains why spreading the word about clinical trials helps research-oriented institutions, centres, and practices, ultimately resulting in improved patient outcomes.

Tell me about your background…
 

When I started my career over 25 years ago, I initially trained to be an optometrist, but I later decided that I wanted to complete a PhD in ophthalmology. I made my formal professional entrance into the ophthalmic industry in 2003, and over time I’ve had the opportunity to step into several different roles. Most recently, I joined Ora as VP of Ora Europe to head up the organization’s European operations. I am also a mom of three children.

Please tell me about Ora, what are the organization’s activities?
 

Ora is a full-service drug and device development company working exclusively in the field of ophthalmology. The organization was founded in the 1970s by an ophthalmologist, Mark Abelson, steadily growing over the decades into the globally capable ophthalmic research firm that it is today. We can support anything from pre-clinical to post-marketing activities, helping our clients at all stages of their product lifecycle. We also have a separate R&D unit that focuses on developing novel endpoints to help identify advantages that new devices and drugs bring to the ophthalmology community, providing a more sensitive way of identifying these improvements for patient care.

What goals you are working towards?
 

Our overarching goal is to make a difference to the clients we work with, but also to the sites that we collaborate with, and the patients involved in our clinical trials. I have worked as a clinician, a researcher, and within industry, so I have a good understanding of all the stakeholders’ needs. It is vitally important that we work closely with all the previously mentioned groups to facilitate excellence in the execution of clinical trials.

We keep asking ourselves: how can we improve upon the methods and strategies used for trial recruitment, and increase awareness of clinical trials among potential candidates? Patients don’t often see research as an option in their care pathway, and they may not be aware of all the ongoing clinical trials applicable to their condition, so we are committed to working with advocacy groups to increase awareness through education within the community.

How do you increase patients’ involvement in clinical trials and in research in general?
 

Ultimately, clinical trials rely on patients – specifically those connecting with the investigators aware of relevant clinical trials taking place at any given time. Ora strives to educate patients about the value and viability of research as a care option, expand their awareness of clinical trials, and increase the number of opportunities available to them. We want to make it so that the barriers to entry preventing patients from participating are as low as possible.

Could you share an example of a successful partnership that you facilitated?
 

We have partnered with the UK’s Macular Society: we supported the Society’s patient-centric congress in September 2021 and had the opportunity to speak about our initiatives – like how we work with patients and increase awareness of clinical trials as a care option. We explained how we involve patients in the trial design and protocols, creating patient-facing information using language that is familiar and understandable, and how we get and use feedback from patients who have already taken part in clinical trials.

As a result, several patients reached out to us directly. I spoke with a diabetic patient who commented that there was no research taking place in the diabetes field. Of course, there is so much research in this area, so this lack of awareness indicated an opportunity for Ora to work directly with diabetic patients and their healthcare providers to promote available options, and support links with ophthalmology sites conducting research in this field. We then worked on identifying other stakeholders within the community who could support patient identification for clinical trials focused on diabetes.

How do you engage with these community stakeholders?
 

We have set up patient advocacy panels in a number of different sub-specialty areas. We ask patients who have taken part in clinical trials about aspects they enjoyed and what they might have found troublesome. We look for ways to facilitate and optimize their journey and make them feel engaged from the start of a trial to its completion. We also aim to improve the relationships between research sites and patients. It is easy to do things as they have always been done, but changes are often beneficial, and what we hear from stakeholders daily really helps us enhance the service we provide to patients.

How do research sites benefit from working with Ora?
 

We have a unique network of sites that we have developed under the umbrella of OraNet^TM, and we strive to make them feel a part of our broader global initiative. We work with study coordinators at these centres to identify areas in which they require more support so that we can assist in a way that meets their needs. We also have a very active training department that includes our Chief Medical Officer and medical monitors developing ophthalmology-focused materials in the clinical trial domain – supporting not only our internal, but also external needs.

How do Ora’s activities differ depending on the region you’re working in?
 

We must be culturally sensitive and empathetic. We have scientific advisory boards that are region- and country-specific, such as the European Scientific Advisory Board, and an Eastern European Scientific Advisory Board, for example. We ask investigators from a particular country what trial recruitment activities they recommend and share the practices that we found successful in other locations as examples.

Do you find this work rewarding?
 

When I first started my PhD many years ago, I felt really excited about doing research that made a difference to patients, and this feeling still motivates me every single day.

Vision has been my focus for over 25 years. It is a function people often take for granted until it is in danger, and the realization hits that the effects can be incredibly serious. It not only affects people’s functional capabilities day to day, but also has an enormous psychological impact, so if we can do anything to improve the quality of life for patients with sight loss, and possibly enhance their vision, it is worth all our efforts.

Any final thoughts?
 

Ora focuses on ophthalmology – that is all we do, and all our employees and partners – clinicians, researchers, study coordinators, and others – are focused on vision research. Our aim is to help optimize the clinical trials we work on and serve our clients, the clinical sites we work with, and the patients we recruit. My main motivation is the patient. We need to remember that we are all patients! If we can find ways to improve people’s quality of life, we advance the field of ophthalmology in a direction that’s meaningful.

I have a message to ophthalmologists: get involved with research if you are not doing it already! With your help, we can find new modalities to serve patients, and offer them care options that could benefit them for the rest of their lives.