NIH (National Institute of Health) has been the force in conducting the landmark clinical trials and conducting the clinical trials in the disease areas that pharmaceutical companies are either not interested in or cannot afford to conduct the trials. NCI (National Cancer Institute) plays the prominent role in conducting the clinical trials in various type of cancers.
These government agencies now also design websites to help with the conduct of the clinical trials. Last year, The National Institutes of Health's (NIH) National Institute for Allergy and Infectious Diseases (NIAID) launched a new website meant to make complying with clinical trial regulations around the world substantially easier. The tool is known as ClinRegs (http://clinregs.niaid.nih.gov/index.php). As described by NIAID officials, it's an "online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research." With this tool, users can look up clinical data on 12 of the most popular countries for clinical research, including the US, China, India, Brazil and South Africa. Additional countries will be added in the near future according to NIH priorities, the ClinRegs team told Regulatory Focus in a statement.
Various clinical research toolkits are available on NIH’s websites. These toolkits provided the policies, guidance, templates (protocol, ICF, Data Management,…), and other essential documents.
- Toolkit for Clinical Researchers by National Institute of Dental and Craniofacial Research
- Trans NIAID Clinical Research Toolkit by National Institute of Allergy and Infectious Diseases
- R&D Resource for Conducting Clinical Trials by National Cancer Institute
NCI also maintain the CTCAE (Common Terminology Criteria for Adverse Events) that has been the standard for reporting and assessing the AE severity. See my previous post about “Dose Limiting Toxicity (DLT) and Common Toxicity Criteria (CTC) / Common Terminology Criteria for Adverse Events (CTCAE)”