Interview: EDETEK's Munther Baara on the paradigm shift in clinical trials

He clearly remembers being told early on in his career that this work was about the moms, the dads, the brothers, and sisters. Everybody was personal to somebody.

He says ‘This was said to me about 20 years ago and at the time, I was healthy, my father was healthy, my mother and brother were healthy, and it wasn’t until I heard this that I thought ‘oh my, what if something happens’.

‘Then later, my dad got diabetes and suffered in his early 30s but when he was in his 60s it started to eat him up. So, he lost his sight, his legs amputated,

and was ultimately non-ambulatory, requiring assistance from my mother to even use the restroom.

‘A lot of times in clinical trials we miss one key factor – and that is the caregivers who are key to the quality of life for the patient. I witnessed this firsthand and strongly believe my dad experienced a greater 15 years of quality of life while he was ill, which can be credited to the efforts and care my mom provided him.’

He said after his father passed away; his mom’s health deteriorated.

‘Within three years she stopped walking and six months after Covid hit, in 2020, she passed away and then a year after that my brother was diagnosed with late-stage cancer and there was nothing that could be done about it. This is what makes it personal for me and motivates me to wake up every morning ready to make a difference.’

Patient and site centered - not just sponsor centered​

Munther says that the sequence of personal events lights a fire in him to make positive changes, like making the process patient and site centered rather than just sponsor centered.

He uses what he calls the four Cs as part of his work model - connect, collect, conform, and consume. Connect and collect the data, consume it in a user-friendly way and conform it into any standard.

He says ‘We're not trying to be everything for everybody. That's number one. And we enable our customers really to pick and choose from our four Cs, which one they want to use with us, basically.

‘On top of this, we have hundreds of years of experienced people, it is not the technologists who came in and thought about a solution – it came from pharma, I have 30 years of experience working in pharma. I started with a small biotech called the Genetics Institute, then I had the wholesome experience of working with patients and on all sides of the business at Pfizer where I was working as the head of new clinical paradigm.

‘My boss has 30 years’ experience, my other colleagues have 25-30 years, so all the leadership were the best in the industry who understand the pain we went through to get where we are – understanding the issues and trying to find solutions for our specific companies.’

‘I have seen a lot of initiatives and really understand the big picture’.

Now at EDETEK and using his experience, he has been focusing on innovation, trends, and emerging technologies where he puts his passion into the paradigm shift in the execution of clinical trials.

As the vice president of product strategy and innovation, he serves as global deputy leader of EDETEK’s product portfolio, providing strategic oversight, innovation, design, and development of new and existing products and technologies. Alongside his team, he manages the creation of product roadmaps, blending vision with data-backed research to ensure long-term competitiveness of product offerings.

‘We develop configurable solutions to empower our clients to work quickly and to address changes that occur during the course of a study.  With configurable solutions, we eliminate code development which includes documenting new requirements, and writing and validating code. By the time you complete the end to end validation process, four to five months, at best, have gone by, so you’re already behind and you don’t know what’s going on in your study.’ 

‘Our platform enables you to point and click to configure the connections and allow the data to flow.’

EDETEK’s system is called CONFORM and its aim is to collect and transform data in near real-time and provide the business with a seamless technical solution for increasingly complex clinical trials. It is described as ‘an end-to-end digital interoperable ecosystem’ by automating the drug development process, shortening cycle times, and reducing the burden on study stakeholders, as well as sites and patients.

‘So, we'll start by connecting to source systems and collecting the data. We validate the content of that data to ensure the structure is correct, then we apply complex business rules using templates, in an automated fashion, across data domains and data providers.’

As a result, issues are addressed early on and proactively communicated to sponsors and/or sites, which contributes to enhancing the relationship between the two.  Additionally, by being proactive, it helps to prevent the same issues from being repeated, in turn, giving sites more time to spend with patients.

Metadata repository for trials​

He said EDETEK use a metadata repository, for the trials or studies, the sponsor can set up their own company or therapeutic area standards or can use industry level standards from the Clinical Data Interchange Standards Consortium (CDISC).

‘Building a new study is not going to take a long time because you're using global libraries and standards that you've used before. As data comes in the system validates the structure of the data based on the configuration in the metadata repository. Through graphic point and click, you can take the raw data and produce a new domains for data review or analysis.’

‘Centrally, you can visualize, review and analyze data across disparate sources. Issues are systematically identified and highlighted and can also be created by end users.  Issues can be tracked and resolved in the system interface by any stakeholders, such as sites, vendors, sponsors, etc., resulting in quicker resolution.  In addition, in one click, users can visualize data lineage and see where the data came from, and what business rules/transformations were applied. This is a key differentiator of CONFORM.’

He said the system also allows the creation of dynamic cohorts of patients, study profiles with charts and trends, and outlines any anomalies. In addition, in one click, the user can view a patient profile or group of profiles, showing the safety and efficacy data in a single location.

‘We didn't stop there. One of the things that we've done nicely medical alerts. An alert can be set-up to fire when it meets configurable conditions, such as liver toxicity, and will notify users immediately to take action.’

Sponsors are empowered to centrally look at the historical data which includes data, metadata, issues, audit trail, lineage, etc…  They can then look at discrepancies and trends to inform future study design.

Cloud computing and artificial intelligence advancements​

Munther has a reputation in the industry for striving to get things done faster, which is part of his mission to improve clinical trial processes. He is well connected and says, ‘I consider myself lucky. I have worked with quite a few people that really had the vision, the collaboration skills and innovation skills and execution.’

‘With all the advancements in the cloud computing and artificial intelligence (AI) and machine learning, we're really going to have an outstanding solution coming up where you get to change the whole paradigm in my mind.’

‘So rather than having to worry about every single graph and listing, with generative AI, you can ask the system a question and it will immediately give you an answer using data listings and graphs. Then you can build on the original question and ask another question. For example, you could ask things like ‘what are the most common adverse events in my study?’ And then you can follow-up and ask how many of those adverse events are serious?  And then further ask out of the serious adverse events, how many resulted in death? In short, you're having a conversation, rather than frustration, with the system. We're really, really proud of this and look forward to releasing it in the near future.’  We call this Chat.IQ.