Dr Sally Tucker of Ora Europe walks through the clinical trial pathway, describing how Ora addresses complexities to make the path as efficient as possible.
In Denver, Colorado, United States, Dr Sally Tucker, vice president of Ora Europe, describes the complexities that Ora overcomes when designing clinical trials.
Hello, my name is Sally Tucker, and I am the vice president of Ora Europe, overseeing all of our clinical operations across the European region. So as we consider the pathway to the approval of any products, we need to consider the complexities and how we address those to make the pathway as efficient as possible. The aim of this is to speed the time to approval for the products that you bring to market.
The complexities that we face increase the larger the trial, and this is something that we need to address particularly when we are thinking about larger Phase 3 trials in which more patients are required, and in which there's often a requirement to think about global site outreach.
So how can we do these things? The first is through protocol design. We need to consider within the protocol what are the requirements of the regulators. We have experience working with regulators across the globe, the FDA, the EMA, the MHRA, the Chinese FDA, and the PMDA. We will address the regulatory requirements and make sure that they are within the protocol design, depending upon which country approval you are seeking.
The second thing that we need to consider in the protocol design outside the regulatory requirements is whether the protocol is clinically executable. It is really important to engage with investigators across the globe to make assessments of the protocol. Does the protocol makes sense? Can it be done within a clinical setting? And we also need to consult with patients. And this is something that we take great pride of doing. We have numerous patient panels, and we consult with these patient panels. How does the protocol design look? Is it too burdensome for the patient? Are we addressing their hopes, their desires, and also their concerns and fears to increase the likelihood for them to want to be a part of the research and the clinical trial?
The next thing we need to consider is the slight outreach, especially in these large Phase 3 trials in which we might have to consider multiple countries. We need to consider the patient demographics, and where the patients are to be found. (We also consider) the competitive environment and the standard of care health care provision in the country that we approach.
How can we elevate research as a care option to patients to optimize recruitment? We also work with the sites and the investigators themselves who work tirelessly on these clinical trials, helping to bring these projects and these product products to market. How can we support them better - training of staff coaching mentorship, collaboration across sites, feeling that they're part of something bigger, broader? And how can we also assist with pre-screening, helping to identify patients to bring to the sites to speed the overall execution of the clinical trial?
The last aspect that we also consider is our patients. We as scientists, investigators, clinicians, researchers, put patient at the centre of all we do we all want to make a difference to the patients that we serve.
So how can we best do that? We have patient panels that we work with, identifying how we can make the protocols less burdensome for them, and how we can support them on their journey, being a part of the clinical trial, and how we can develop patient facing materials that address their needs. And also engage with them throughout the duration of the clinical trial in a compassionate and empathetic manner so that they feel engaged.
They are reminded why they are in the trial, and they are appreciated for being in the trial. We are committed to all of the stakeholders that we work closely with the companies that work tirelessly to bring novel new products to market that can address the unmet needs of patients, to the sites who work so hard and conducting the clinical trials and the patients for whom we all serve. Thank you.