For a broad perspective, investigator-initiated studies offer clinicians an opportunity to do all relevant activities of the studies, including study design, data analysis, interpretation, and data archiving. However, initiating, sustaining, and taking an investigator-initiated study to realization is not easy. While the benefits of doing an investigator-initiated study are manifold, numerous challenges need to be addressed before embarking on an investigator-initiated study. These challenges exist, ranging from regulatory submissions, continuous monitoring, to personnel training, statistics expertise, data management, and medical writing.
During the protocol development phase, the potential difficulties include inadequate / incomplete literature searching while formulating a research question, inadequate training to address ethical issues, lack of familiarity with basic research methodology, apathy toward registering the study with a clinical trials registry, and inadequate planning of safety monitoring.
During the study phase, the potential difficulties include inadequate implementation of methods, nonavailability of an internal monitor and quality control, inadequate measure to prevent dropouts, inadequate archiving facility, inadequate manpower to handle large data and execute statistical analysis, and failure to update the study report.
During the post-study phase, the possible difficulties include lack of publication policy at the protocol development state, authorship disputes for multicentric studies, dispute over data ownership, and lack of capability for publication.