In this exclusive sneak peek feature, we speak with Maya Zlatanova (FindMeCure) ahead of her presentation at the inaugural Real-World Evidence 2020: Rare Diseases and Innovative Therapies meeting. Discover her insight and register to attend RWE 2020 now!
Maya Zlatanova is the CEO of FindMeCure Ltd. Zlatanova is a healthtech entrepreneur, clinical research expert and pharma industry speaker, with over 15 years of experience in clinical research regulations, patient recruitment and engagement, and clinical trial feasibility and operations.
Zlatanova is inspired by stories, not just facts, and believes the clinical research industry faces overlooks many stories every day that are calling for a change in the way they think and operate.
What is the importance of patient and/or stakeholder engagement in designing clinical trials?
When designing a clinical trial, one must go through protocol development; I have personally witnessed clinical trial protocols structured in such a way that it means that practically no eligible patient exists for trial participation — when we combine indication with eligibility criteria — or that the clinical trial schedule is absolutely impossible to comply with if you are a patient with pain, living far from the trial site, working, have kids etc. This calls for urgent patient and caregiver engagement in clinical trial design.
I am excited to see people finally sit together and really try to overcome challenges together because they understand that if we don’t do it together, then it won’t ever happen.”
On the other side, patient communities have come to realize that they can no longer grow and have real impact without learning how to be more helpful to companies. Many of them have already started education and preparation for that.
Pharma companies have also realized that they are at a moment where their customers — patients — have a lot more freedom to choose and decide what’s best for their health; knowing what those patients want, and how they want it, is an essential aspect of rethinking their strategy.
I am excited to see people finally sit together and really try to overcome challenges together because they understand that if we don’t do it together, then it won’t ever happen. Patient engagement is so important, not just for society, but also for the future of pharma — there is no other way.
What is the importance of using real-world evidence to effectively locate and recruit patients for trials, especially in the rare diseases field?
One of the main jobs carried out when planning a clinical trial is defining which locations and sites will recruit and monitor patients. If you select the wrong locations, this will result in a lack of eligible patients being recruited.
It’s proven that knowing patients’ pathways in each country gives you essential points to consider when considering why you should expect challenges with recruiting and maintaining patients in a clinical trial.”
Today, 40% of sites specified in clinical trial plans recruit between zero and one patients only. In order to prevent this, it is essential to know where eligible patients are located, why they would participate in a study and how to help them be monitored at their convenience, following their lifestyle and specific condition requirements. This is where real-world evidence can be of utmost value.
Without giving too much away, what do you hope are the key points for the audience to take away from your talk at Real-World Evidence 2020: Rare Diseases and Innovative Therapies?
- What makes rare diseases special in terms of patient recruitment and how real-world evidence help can
- What the sources of real-world data for this use look like
- Tricks and hacks for using real-world data in designing clinical trials
Why do you think events like Real-World Evidence 2020: Rare Diseases and Innovative Therapies are important in progressing the field?
RWE 2020 is an important event because it will bring so many different key stakeholders together; it is important for these stakeholders to exchange know-how about areas that are important to all of us. Patient recruitment is a huge challenge for everyone; sponsors are trying more and more to improve their GO/NO GO decision making process and avoid clinical trial delays and failures. It’s proven that knowing patients’ pathways in each country gives you essential points to consider when considering why you should expect challenges with recruiting and maintaining patients in a clinical trial.
With respect to rare diseases, this aspect is even more critical, as we are dealing with a far smaller patient population, spread across the world, so there is almost no room for mistakes.