TECHNOLOGY & DATA MANAGEMENT


before beginning discussions, while the FDA focuses on establishing a process for data collection first. As a reslt, researchers woring with the A ris collecting different data than what reglators are seeing, ervais eplains. In either case, ervais and van ij agree


that early data collection is ey to developing a sccessfl digital endpoint. This is particlarly tre for ervaiss own


eperience with 5 in chenne msclar dystrophy. If we had more money or cold do it again, we wold have invested more money and time into data collection, he says.


Pharma investment falters To increase the ptae of digital endpoints, pharma will have to invest more resorces into inclding these novel otcomes in latestage trials, ohen eplains. rrently, pharma pors hge sms into rnning clinical trials, while comparatively little fnding goes into validating clinical endpoints. Additionally, s that implement clinical trials are heavily driven by precedence, maing the pharma indstry as a whole conservative in adopting changes. In the past decade, pharma companies sponsored fewer than onethird of all hase II and hase III trials sing activity monitors, according to lobalatas linical Trials atabase. eanwhile, instittions sch as academic research centres and government organisations acconted for most trial activity.


What’s next for digital endpoints? Going forward, it is also unclear what role artificial intelligence AI will play in analysing data from digital endpoints. any pharma companies are already investing in digital biomarers, which cold se AI to analyse granlar data on measres sch as disease progression and drg response. owever, according to ervais, AI might not


play a major role in the ftre of digital endpoints. eglatory bodies sch as the A mae it clear that any otcome measres sed in registrational clinical trials mst be anchored to a patients perspective. e eplains If an endpoint is based on an


AI algorithm, good lc convincing reglators that it is clinically significant for patients.


40 | Outsourcing In Clinical Trials redit htterstoc.com


till, despite many ncertainties and implementation barriers, eperts say the nmber of validated digital endpoints is liely to jmp in the coming years. ew endpoints introdced in the space


today are the conseence of decisions made five years ago, ervais says. I epect the nmber of digital otcomes in se will dramatically increase over the net two years. ecentralised clinical trial coverage in linical Trials Arena is spported by ma. ditorial content is independently prodced and follows the highest standards of jornalistic integrity. Topic sponsors are not involved in the creation of editorial content.


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