AstraZeneca has just published an incredibly revealing and useful paper in Nature Drug Discovery, in which a thorough analysis of AZ's clinical trial successes and failures is presented.
Among the key findings:
- 82% of projects were active or successful in Phase IIa when they included efficacy biomarkers, compared to 30% of projects without biomarkers;
- Safety and PK/PD biomarkers are critical to successful projects;
- Clinical biomarkers should be an "integral part of the R&D programme," and used to guide patient selection "as early as possible;"
- 85% of AZ's projects now include a "personalized health-care strategy," and such programs are four times more likely to be successful.
Bottom line? Biomarkers confer much higher likelihood of success at every stage of development, and for every major aspect (safety, dosing, efficacy, patient selection) of the development process.
AstraZeneca and others that build biomarkers into their projects early will be the big winners coming out of the next decade's clinical trials.