Pharma Technology Focus Excellence Awards 2024: TrialHub

Maya Zlatanova: TrialHub IQ is powered by custom LLMs in combination with validated data handpicked by clinical trial and medical experts, which makes it extremely reliable and powerful in gathering hard-to-find answers on critical trial planning questions. For example, when you do your budgeting you want to be able to calculate not only recruitment rates, but also screen-failure rates, something that takes a huge amount of manual research and doesn’t exist in regular databases.

Maya Zlatanova: We have been pioneering AI technologies for clinical trial planning and strategy oversight since 2016. LLMs is just one piece of the puzzle. They are backed by NLP and Machine Learning for various purposes. One simple example is the way we provide reliable short answers by also providing full visibility of the data sources as well as the ability to choose a timeline and the data source itself. So if you only want TrialHub IQ to source your answer from studies conducted in the last five years, it can.

Maya Zlatanova: Since the launch of ChatGPT, it became clear that people need answers–short, quick information that can enhance their decision making. Our Industry has a more specific need though: our experts need answers from validated sources as well as oversight of where this data is coming from. Another important component of TrialHub IQ is the ability to guide the process by providing hints on what else can be found in terms of insights and what else should be considered. These are a series of follow up question prompts we automated based on years of experience working with clinical research and feasibility experts on their Jobs-to-be-Done needs.

Maya Zlatanova: TrialHub IQ is a treasure of insights on the patient journey and what stops patients from participating or staying in a clinical trial. Very often, clinical trial teams, when trying to understand patients, organise focus groups first. This is incredibly helpful but very slow and costly and it usually ends with 100-page reports. These reports together with all the available research already done by other experts and companies can be structured and summarised by TrialHub IQ. What’s more, it can be converted from qualitative to quantitative insights on the patient journey. These insights can be easily considered along with metrics like recruitment rates, site’s performance etc., so that patients’ needs can be considered from the start.

Maya Zlatanova: There are many cases where we supported our clients to conduct a successful clinical trial. TrialHub’s focus is on preventing costly amendments (58% of trials) and recruitment challenges (90% of trials) because we know first-hand how difficult it is to go through them. We are most proud of the cases where we were able to empower a better clinical trial strategy upfront and streamline both recruitment and operations. Last year, for example, we were able to predict a substantial amendment by analysing the local standard of care of the biggest markets where the company was preparing to run their Phase 2 trial. It turned out that they assessed the therapies but missed a medical device that was just introduced a year or so ago which would have prevented their target patients from joining the trial. We had to adapt the eligibility criteria to make sure these patients can be included too and that resulted in much faster recruitment (between 3 and 6 months faster according to the initial projections).

Maya Zlatanova: Data is at the heart of TrialHub and accuracy is the Number One Priority. Therefore, there is a whole process behind the way we validate, structure and process data. It’s a mix between algorithms, in-house medical experts and local advisors to ensure we are using the most reliable data sources in the most accurate way. We overcome both language and format barriers and on top of that most of our data sources get updated in real time.

Maya Zlatanova: We follow the best practices in any tech business to ensure our client’s data is protected. With each client we go through a due diligence process, and we also follow the compliance requirements and standards.

Maya Zlatanova: Planning a clinical trial is extremely difficult because you have to consider multiple factors. An example is when you plan a vacation: you need to pick a place based on where you will get the best weather, affordability, hospitality, safety, etc. Not having all these pieces of the puzzle in one place makes it impossible to make decisions without compromising on one or the other. In clinical trials, for example, you can choose the best performing country based on past patient recruitment speed, however, if their standard of care does not cover the treatment defined in your eligibility criteria, you may not find any eligible patients no matter how great the sites are. Being able to combine past performance with regulatory requirements, standard of care and the other critical factors that define your future clinical trial is a must. The Industry is starting to understand this.

Maya Zlatanova: There are 2 strategic developments that will contribute to next-level planning of clinical trials. The central one is ensuring that the patient journey is considered when assessing the patient burden. Our global access to country-specific Standard of Care in combination with our trials intelligence will allow our clients to understand what is feasible for their protocols much faster.

Maya Zlatanova: Until we built our Standard of Care module a few years ago, the Industry relied solely on RWD based on claims/EHRs which are limited to the USA and a few hospitals here and there. The moment they had to go outside of the USA, they were relying on heavy manual research from their local teams (if they had any) or data intelligence tools built for pricing purposes and not standard of care assessments. Our clients were the ones to insist we bring this data to the market as they were often forced to skip the standard of care assessment because of lack of resources and time. We decided to take on the challenge because the way we see it, Standard of Care is the beginning of the real patient feasibility process that ensures the trial is not only feasible from a trial design and site perspective but from the patient perspective as well. Because here’s the truth: your biggest competitor in any country is not another similar trial, it’s the patients’ access to treatments.

Maya Zlatanova: Here are two examples:

Q1, 2023 we saved a top 10 pharmaceutical company $1,6M by avoiding a substantial amendment and a few months of patient recruitment. 

Q4, 2023 we tripled the recruitment speed of a Phase 3 clinical trial that was in rescue mode. This was achieved by equipping the CRO and biopharma teams with TrialHub’s insights on the patient journey and countries’ feasibility index and helping them revisit the initial strategy both with countries and patients.