Metamorphoses in oncology trials – Zoom in
Mis à jour : mars 18
As innovation costs in medical research have never been so high, new, more sophisticated ways to conduct clinical trials are being adopted by sponsors.
More and more breakthroughs in oncology research and cancer treatment are brought to light every year, rising hope for millions of patients. But those innovative treatments require proper clinical validation, which takes a lot of time, effort, and money.
To meet the challenge, clinical trials evolve : master protocols classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies. The secret ? Their flexibility. Being able to test multiple treatments and/or multiple population of patients within a single study, and being able to adapt protocols as they go, make those trials more efficient, less time consuming and therefore more ethical. As Jay J. H Park concludes in his paper (Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols, Sept 2019) : “More efforts to improve awareness and training are needed to apply these innovative trial design methods to fields outside of oncology. The number of master protocols will continue to increase at a rapid pace over the upcoming decades.”.
And there is no reason to doubt that. As a matter of fact Europe and France are in good position to embrace and enhance those novative ways in oncology research. Since 2019, the European founded project EU-PEARL links together different clinical investigation sites from different countries, enabling them to perform multi treatment testing against the same control group.
But Europe has always been, and righteously so, extremely rigorous regarding patient safety and well-being. Having adaptive protocols rises the fear of misconducted trials due to multiplication of treatments and specialites involved, while the risk of a lack of appropriate information and safety for patients with diverse and complex backgrounds can not be underestimated.
Hubical is here to make sure those master protocols translate smoothly into real life, giving doctors an easy-to-use way to widely spread an acute and up-to-date information to their patients, through all clinical investigation sites involved.
March 11, 2020
Dr. Alexandre Viau