Increasing patient awareness of clinical trials

The clinical research organisation, Ora Inc, has been working to increase awareness amongst the patient community about the “scope and breadth” of ongoing ophthalmic clinical trials, with the aim of improving understanding of clinical research as a care option, and enhancing the patient experience during studies.

The global organisation supports pharmaceutical and medical technology companies with their research activities and discoveries of new drugs and ophthalmic devices for the treatment and assessment of diseases of both the anterior and posterior segments.

The team at Ora recognised that, though there is a “huge desire” within the patient population to participate in studies, there is a general lack of awareness around available opportunities “that keeps people from enrolling.” As a result, through a network of patient advocacy groups and patient panels, the organisation is working to better understand how clinical trials can meet the needs of patients who are experiencing various ophthalmic disorders.

Sally Tucker, Ora Europe’s vice president, told OT that the effort included conversations with a panel made up of patients who all had age-related macular degeneration and had previously been involved in clinical trials.

“There was a huge desire within this subgroup of patients to be involved in clinical research,” Tucker said. “They have been diagnosed with a condition that isn’t curable and is progressive. There are genetic and hereditary factors associated with the condition, so it could affect their families in the future.”

She continued: “There was a huge intrinsic desire for them to be involved in clinical research, in the hope that it could potentially assist them, but equally, that it could assist future generations.”

In conversations with the panel, one patient shared that when it came to clinical trials, “Everything I’ve learnt, I’ve learnt by chance.”

This project led the Ora team to explore how they could more effectively serve this patient community by improving awareness of clinical trial opportunities, and bettering peer-to-peer education. This has to be done in a “thoughtful manner” Tucker said, in a way that did not increase the burden on the sites where the trials take place.

To support efforts to raise awareness of trials, and increase peer education, the company launched a patient-centred webpage: Ora Connects.

Launched in September, the website will be developed over time, and includes patient education materials, links to advocacy groups, and videos from other patients.

At the time of launching, the website already supported a panel of macular degeneration patients, and was developing a panel of patients with diabetes.

“As we look to expand those activities, we would love to have panels in every single different sub-speciality: a panel for patients with glaucoma, a dry eye panel,” Tucker said. “The panels will tap into patient’s understanding of their day-to-day symptoms, any difficulties they have, and help to get more feedback about their experiences in clinical trials, so that we can enhance their involvement.”

“The more we can learn from patients, the more we can improve the service that we can provide,” she said.

As part of the website project, the organisation has been developing a patient registry, which will enable patients to register their interest in hearing about clinical trials, through a GDPR-compliant format.

“We would like to provide those patients with a regular newsletter that gives them insight into some of the research activities that are being done in ophthalmology,” Tucker explained.

Looking further into the future, she suggested the organisation will look into how primary care could be engaged with the process.

She said: “We have such a fantastic primary care community, it is about how we can work with this group of individuals to perhaps assist with the pre-identification of patients for a study, as well as facilitating better communication between the different stakeholders.”

At this stage, primary care involvement is at a research-gathering point, and Tucker acknowledged: “I’m very keen to determine how we can involve optometric centres, but there is a lot of groundwork to do before we get there.”

Over the next 12 months, Ora plans to continue exploring how to engage patients with clinical research activities from an earlier stage.

“As clinical researchers, you develop a protocol, patient information sheet, and informed consent form. Having patient involvement to look at the protocol from their perspective could tell us if the study is overly arduous, for example, and might pose issues for patients wanting to get involved.”

Similarly, when preparing patient information sheets, words or phrases that might be normalised from a clinical perspective, such as ‘injection’ could put a patient off, or require further description to alleviate the ‘fear of the unknown’ for the patient.

“Getting that candid feedback from patients, we can really optimise how those protocols and information sheets look, and this is something that we would love to work with patients on more if the sponsors that we work with would like to do so,” Tucker shared.

The organisation has been working with patient advocacy groups, including the Macular Society, to increase awareness of research, and has also partnered with higher education facilities, including Aston University, to highlight the future career opportunities available in research for student optometrists.