Both regulators and sponsors need to use more agile trial designs to remove the heavy data collection burden on trial sites and patients.
During a session at HLTH Europe, which was held in Amsterdam, the Netherlands, from 16 to 19 June, panellists emphasised the need for industry-wide collaboration to adopt more adaptive trial designs, ensuring robust data collection while avoiding unnecessary burden.
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Meri Beckwith, co-founder of “anti-CRO” Lindus Health, said that regulators such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) can impose excessive requirements on sponsors when it comes to endpoints; however, sometimes the sponsors are making those decisions.
“We’ve seen studies where the FDA or the EMA are frankly putting ridiculous requirements on the study. We’ve also seen examples where it’s not the reviewer, it’s the sponsor, you know, why are we doing PK for a Phase III study, so I think it can be both,” Beckwith explained.
Karina Morley, global head of research innovation at AstraZeneca, commented that it would help sponsors reduce patient data burden if regulators accepted more alternative trial designs.
She said: “If the regulators were happy with more dynamic studies where you didn’t need every study that had a placebo-controlled arm, you would look at interim analysis, where you would see which populations were benefiting the most and then you go down that road.”
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By GlobalDataMorley added that regulators are still not accepting real-world data (RWD) in later-stage studies, another area which would help reduce the data burden.
She continued: “At the moment, we’re still forced down the road of these big, randomised controlled trials (RCT), with follow-ups of two and three years, so you know which populations are benefiting the most. That’s a big challenge, but that’s coming from the regulators, it’s not coming from pharma, and that’s where we need to get better, but that’s why the whole ecosystem needs to move and be a bit more agile when it comes to trials.”
Beckwith added that contract research organisations (CROs) are partially to blame for agreeing to more intensive data collection.
He explained: “I’ve never really understood why sponsors do this because it’s pretty obvious when you’re collecting too much data. The CRO should be telling sponsors that they can’t get patients to do all this.
“It should be on the CRO to push back more, and most CROs will only be too happy to deliver a protocol that’s going to be a huge operational undertaking.”
Beckwith also commented that technology and decentralised trials (DCTs) can also be utilised to reduce patient burden, explaining how Lindus Health is working on a study using an Oura ring to evaluate exploratory endpoints in housebound patients.
He added: “We’ve designed a study where we’re collecting all the data we need, but it’s completely within the patient’s home, and this has just made the entire programme possible, and it’s thanks to wearable endpoints like Oura rings with totally passive monitoring, as well as a home nurse. I think it’s a really good example of putting some of these principles around decentralisation into practice without compromising the scientific integrity.”
Other sessions at HLTH Europe discussed space health, including how BioOrbit is hoping to manufacture crystallised proteins for monoclonal antibodies (mAbs), and how European pharma needs scalable models to succeed in the US.
