RE: All in20 Nov 2021 12:51
A few things to remember when trying to work out chances of success. Synairgen are able to skew their chances of success in the P3 trial design in a number of ways.
• they get to select the type of patients they want (ie the breathless, of which they have plenty of data to show the drug works particularly well with these patients through multiple trials)
• that get to determine what the primary endpoints and secondary endpoints are (based on previous trial successes).
• they are able to apply their preferred analyses to the data sets (this was determined from the P2 results -see the P2 lancer paper)
So basically, based on 20 years of research, trials and understanding the type of patients and settings that SNG001 is likely to give the best outcome the company is able to design a trial knowing that chances of success are high. P2 trials are really where pharma companies work out whether the drug is a ‘dud’ or not. P3 trials are hugely expensive and ‘big pharma’ don’t get big by wasting P3 money on duds.
Most P3 clinical trials fail due to poor trial design. Parexel have a good article about this on their website if anyone wants to understand why P3 trials can fail. Good trial design stacks the odds in the favour of success.