For many clinicians, informed consent is thought of as a signature on a document, but it should be a process that leads to greater understanding of what lies ahead for patients participating in a clinical trial. Though it took our industry 20 years to embrace electronic data capture (EDC), and at least 10 years to embrace electronic reported outcomes/electronic clinical outcome assessments (ePRO/eCOA), both now play an increasingly crucial role in new drug development. Electronic trial master files (eTMF) are also making significant gains. Still, even though “patient centricity” has become the new buzzword, our industry has not yet implemented an electronic informed consent (eIC) process that would benefit our patient partners in clinical trials. Read More.
