Challenges of independent clinical research

Pharmaceutical companies fund most clinical trials on drugs. However, there are clinical issues that might not be a priority from a commercial point of view, but that should certainly be addressed, given their importance for patients and society in general. Independent clinical research represents a fundamental pillar here and its basic element is investigator-initiated studies/trials. In these studies, it is the researcher who conceives the idea, develops the project and also acts as the sponsor. Most researchers are familiar with participating as collaborators in studies sponsored by pharmaceutical companies. In these studies, the company is in charge of all the scientific, legal and financial aspects, leaving the responsibility of the researcher mainly limited to the inclusion of patients and compliance with the protocol. On the contrary, the start-up and development of an independent research study requires considerable resources - of knowledge, money and time - and careful planning on the part of the researcher. In this manuscript, we will review the main characteristics of the studies initiated by the researcher and their fundamental differences with those sponsored by the pharmaceutical industry. We will also outline what its strengths and limitations are. Finally, we will propose some solutions to the main challenges they pose. Our ultimate goal is to stimulate potential researchers to undertake the challenge of conducting an independent clinical research project.