Every so often, clinical tries are said to ‘fail’, but can the trial actually fail? According to John Lechleiter, President and CEO of Eli Lilly and Company, “a clinical trial is a failure only if we can’t learn from it.” He believes that no matter how a clinical...
The US Food and Drug Administration (FDA) has been looking into ways to test Electric Health Record (EHR)-to-Electric Data Capture (EDC) approach for clinical trials. The administration believes that this could open up new opportunities for clinical trials through...
In March, Apple Inc. introduced ResearchKit, a platform where its users can track personal health data and participate in health studies using their smartphone. Some of the apps include mPower used for Parkinson’s disease, My Heart Counts for cardiovascular disease,...
In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...
Conducting clinical research is extremely time consuming given the extensive requirements necessary to begin a clinical trial. Protocols must be adhered to, results must be extensively recorded, and most importantly, patients must be protected complying with Section...