Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España.
Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, España.
Gastroenterol Hepatol. 2021 Oct;44(8):599-610. doi: 10.1016/j.gastrohep.2020.09.005. Epub 2020 Oct 22.
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.
制药公司为大多数药物临床试验提供资金。然而，从商业角度来看，可能有一些临床问题不是优先事项，但鉴于它们对患者和整个社会的重要性，这些问题应该得到解决。独立临床研究在这里代表了一个基本支柱，其基本要素是研究者发起的研究/试验。在这些研究中，是研究人员构思想法、制定项目并充当赞助商。大多数研究人员都熟悉参与制药公司赞助的研究作为合作者。在这些研究中，公司负责所有科学、法律和财务方面的工作，而研究人员的责任主要限于纳入患者并遵守方案。相反，独立研究的启动和发展需要相当多的资源——知识、金钱和时间——以及研究人员的精心规划。在本文中，我们将回顾由研究人员发起的研究的主要特征及其与制药行业赞助的研究的根本区别。我们还将概述其优缺点。最后，我们将提出一些解决方案来解决它们带来的主要挑战。我们的最终目标是激励潜在的研究人员承担开展独立临床研究项目的挑战。
