Clinical trials are prospective studies in volunteers that enable a pharmaceutical manufacturer to measure the risks and benefits of a new therapeutic intervention. These trials follow a well-defined pathway that allows careful elucidation of positive and negative effects in concert with supervision from health authorities at every phase. As manufacturers became increasingly efficient in moving new chemical entities to clinical testing, invariably, trading fixed clinical development costs to variable outsourced costs became the biggest innovation in clinical development. These steps allowed for focusing on internal pipelines and outsourcing of clinical development to globally located experts.
Convergence of mobile and electronic health (e.g., EHR) will enable the next wave of innovation in clinical trials. Clinical trials need to be adapted for health-seekers or information-seekers that will have considerable information about their disease and treatment options. Policy and regulatory concerns, namely around exchange of confidential information, need to get addressed.