A clinical trial can be stopped under specific circumstances, guided by predefined rules outlined in the trial protocol, and based on the ongoing assessment of participant safety, data integrity, and scientific validity. At times, the sponsor will ask to put the study on hold until they further investigate the issues. Stopping Rules in Clinical Trials […]
Good Manufacturing Practice (GMP) is an essential part of Quality Assurance that ensures products are consistently produced and controlled to meet the quality standards appropriate for their intended use, as outlined by the Federal Food, Drug, and Cosmetic Act (FD&C Act). GMP encompasses the entire production and quality control process, including key areas such as: […]
Good Clinical Practice (GCP) is an internationally recognized standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. GCP ensures that clinical trials are carried out in a manner that guarantees the credibility and accuracy of the data and results, while also safeguarding the rights, integrity, and confidentiality of the […]
Good Laboratory Practice (GLP) refers to a set of principles and guidelines aimed at ensuring the quality, reliability, and integrity of non-clinical safety studies in research and development, particularly in the context of pharmaceutical and chemical testing. GLP is crucial in promoting transparency and consistency in laboratory operations and results, thus safeguarding public health and […]
What Are Clinical Endpoints in Clinical Trials? A clinical endpoint is a measurable outcome that directly demonstrates how a patient feels, functions, or survives as a result of a specific medical intervention. Clinical endpoints are used in clinical trials to assess the safety, efficacy, and overall impact of a treatment, making them a cornerstone of […]
A Case Report Form (CRF) is a critical tool in clinical trials used to systematically collect data from participants according to the trial protocol. The purpose of the CRF is to ensure that all the necessary information about the trial subjects is gathered in a consistent and regulatory-compliant manner. CRFs are used to record both […]
What is an Investigator’s Brochure (IB)? An Investigator’s Brochure (IB) is a key document in clinical trials that provides essential information about an investigational drug or treatment. It serves as a comprehensive guide for investigators, study staff, and other stakeholders involved in the trial, ensuring they have the necessary information to conduct the research responsibly […]
Key Objectives of Clinical Trial Phases: From Safety to Long-Term Impact Clinical trials are conducted in distinct phases, each with specific objectives to ensure the safety, efficacy, and optimal use of new medical treatments. These phases, ranging from early safety studies to post-approval monitoring, form the backbone of drug development and regulatory approval. Phase 1: […]
The drug development cycle from discovery to new drug application (NDA) approval and ultimately hitting the market is intricate; it can take an average of 12 to 15 years to receive FDA approval. Additionally, the FDA holds the right to reject the NDA even after years of work. Here’s a detailed layout of the drug […]
From my personal experience working as a Clinical Research Coordinator (CRC), I can confirm that CRCs are the backbone of clinical research. They are also sometimes known as a Study Coordinator. Their role varies slightly based on how big the study team is and how big the organization they work for is. Other variable factors […]