After years of little innovation, a number of new treatments are entering Phase II and III schizophrenia clinical research. As the demand for trial sites increases, this means that less experienced sites will have to contribute to meet enrollment targets.
Decision-making is crucial in the development and implementation of a protocol and those that are made impact investigational sites. These decisions may include everything from what measures to include, inclusion/exclusion criteria, how to communicate with sites and even how to encourage the enrollment and retention of subjects. While many of these decisions may stem from a regulatory requirement or the need to gather specific data points, other operational decisions may be based solely upon the experience of the project team.
