Back to School 2020
Master protocols should not be a one-off phenomenon confined to COVID-19
COVID-19 gives a master lesson in platform trials
COVID-19 gives a master lesson in platform trials.
This is the fourth article in BioCentury’s 28th Annual Back to School package. In the opening piece, BioCentury called on biopharma to convert its COVID response to a new era of efficient drug development.
COVID-19 has shown how a mammoth network of platform trials would have system-wide benefits for biotech and patients.
At least 13 master protocol platform trials have been launched for COVID-19 in the space of six months, providing an unambiguous vote of confidence in the power of these studies to expedite drug development.
As the industry assesses the lessons of the pandemic, it’s time to identify where and when master protocols can be leveraged in other diseases to address the public’s expectation for faster access to new treatments.
In the process, the industry will need to carry out an honest reckoning of why drug developers don’t use these designs more often.
Master protocols that use adaptive platform designs allow compounds from different sponsors to be tested using a uniform protocol and a single control arm. Adaptive platform trials can use fewer patients than traditional randomized control trials, are less costly for companies, and most important, they deliver an answer faster as to whether to pursue or drop a candidate.
These trial designs have been the go-to