Objective: To identify the incidence of clinical conditions/diagnoses following initiation of a given drug. We will systematically calculate incidence rate and incidence proportion for all drugs and all conditions across various times-at-risk and the inclusion/exclusion of patients with incomplete time-at-risk. This analysis will be executed across multiple databases and both summarized numerically and graphically from an aggregate table as well as detailed for each individual database. These results will then be shared via a searchable, public web site.

Rationale: Although drugs often undergo extensive testing during clinical trials, little is known about the real world incidence of conditions following initiation of a given drug. The limited evidence which does exist is often marred by poorly defined target cohorts, time-at-risk, and statistical metrics for incidence, along with wide variations across the literature. Therefore, what should be a simple question, “What is the likelihood I will experience a condition after starting this drug?” is difficult for patients and clinicians to answer.

Project Lead(s): George Hripcsak, Patrick Ryan

Coordinating Institution(s): Columbia University, Janssen R&D

Additional Participants:

Full Protocol: <if available, a link to protocol. not necessary for initial planning>

Initial Proposal Date: 10/18/2017

Launch Date: TBD

Study Closure Date: TBD

Results Submission: SFTP