
Patient awareness of clinical trials and resignations across the industry have slowed and prevented the continuation of research, which could hinder treatment options for patients, an ophthalmic research company has warned.
Sally Tucker, optometrist and vice-president at Ora Europe, told Optician that clinical research was complicated and required coordination between different groups over a large amount of time.
Recruiting a sufficient number of patients and having well-trained, specialised staff members to execute protocols were needed to run trials effectively, Tucker explained.
‘In the absence of either one of those two elements, progress immediately comes to a halt, and promising therapies never get the opportunity to move further down the pipeline for development. Right now, we’re looking at a situation where we may be limited in the number of patients and qualified staff members available to participate in clinical trials, and that could be a huge problem moving forward,’ Tucker said.
Optical practices could have a huge influence on recruiting for trials, Tucker explained, as they have established relationships with patients who were potentially suitable candidates.
A stretched workforce
Generally, patient participation in clinical research was low and Tucker explained that estimates suggested only 3% of patients would ever enrol in a clinical trial.
In Tucker’s experience, many patients have simply never heard about ongoing clinical trials and do not get the chance to take part, even if they would want to. ‘That’s something that has to change,’ she said.
‘At Ora, we’re taking patient feedback very seriously and using it to develop better methods for education and outreach. One of our patients talked about a “Massive void between your optometrist, your GP, and your local hospital”. As an international clinical development partner, we have the relationships and capabilities needed to fill those gaps. We have a huge opportunity to connect the entire industry – sponsors, sites and primary care all included – and create systems that bring information on relevant clinical trials to the patients who need it most. Our expertise and positioning provide us with a really unique level of access and authority, and we’re so excited about some of our patient-centric communication and advocacy initiatives. There’s a real possibility to greatly expand the treatment options for patients who want to get involved, and we can help facilitate that in a big way.’
Retaining staff to effectively carry out clinical research was a problem created by the pandemic and related to increased pressure, stress and fatigue among healthcare workers who re-evaluated their work-life balance. ‘With some workers leaving, it left many of their teammates who remained spread too thin, and it’s become hard for a lot of people to meet the demands originally meant for a larger team,’ Tucker said. Ora Europe has been fortunate to not be affected by these challenges, she added.
Disruption in development
If the ability to effectively run clinical trials was slowed or prevented then so would the advancement of treatments, Tucker explained. A lack of trial participants and staff to run trials would mean processes take longer or get delayed.
‘Strong enrolment numbers and confident, qualified staff members are also needed to make sure that the data coming out of a clinical trial is reliable, of high quality and clear. Without a durable data package, even therapies with merit may not get the okay to move forward,’ she said.
In the worst-case scenario, it could mean some trials never take place at all and a potentially transformative treatment never gets the opportunity to start a process that could change lives, Tucker added. ‘Whatever the extent of the problem, clinical research and the patients that depend on it, suffer,’ she said.
Any patient living with an ophthalmic condition, such as dry eye disease, could be affected, even if therapies were already available. However, Tucker added that people living with rare or progressive and potentially debilitating diseases would be affected more by the disruption in development of novel therapies.
‘People with inherited retinal diseases or age-related macular degeneration don’t have any current avenues for treatment and, without clinical research, they may be left without any ability to manage their conditions on a day-to-day basis.
‘For these people, a lack of treatment isn’t just an inconvenience or an irritation, it could mean a dramatic reduction in their ability to function in everyday life. The solutions available to them today aren’t nearly enough as they are, so clinical research has an incredibly powerful importance for anyone in those groups,’ Tucker said.
Conducting conversations
Tucker believed that if a patient was presented with the right opportunity during a consultation and had the benefits explained to them then they would be more likely to participate in trials. This could speed up the development process of therapies that could help them and other patients.
‘Through the work that our team has done with ophthalmic patient panels, it’s become clear that clinical trial advocacy is invaluable to patients and it gives healthcare providers an opportunity to share pathways for alternative care.
‘If we want to continue the advancement of clinical research, then we need to do everything we can to help patients get involved, but in a thoughtful way not to overburden sites so as to ensure we are benefitting everyone in the healthcare space who act as stewards for the health of their patients,’ she said.
In order to continue the development of meaningful treatments then changes needed to be made and relying on 3% of the patient population would not lead to breakthroughs, she added.
‘It can be hard for healthcare providers to feel comfortable talking about clinical trials with their patients – often there’s the fear that they may lose their patients to another practice, or frighten people who don’t understand the process. But if conducted the right way, these conversations can act as critical gateways for patients into new communities of people with shared experiences, help them find relief for their conditions, and deepen their trust in their healthcare provider. Ultimately, it can even help bring new therapies to market,’ Tucker said.