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 […]
How Does Dose Escalation to Find MTD Work in Phase 1 Clinical Trials? Dose escalation is a critical part of Phase 1 clinical trials, where the main goal is to determine the Maximum Tolerated Dose (MTD) of an investigational drug. This process is especially important for drugs with low therapeutic indices (TI), such as cytotoxic […]
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 […]
Why Placebo-Controlled Trials Aren’t Always Used Placebo-controlled trials are often seen as the gold standard in clinical research because they offer a clear comparison between a new drug and an inactive substance, helping to determine the true effects of the treatment. However, there are several situations where using a placebo is either impractical or ethically […]
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: […]
Clinical trials are meticulously designed to test the safety and efficacy of medical interventions. Various trial designs are employed to suit the research objectives, patient populations, and phases of development. Among these, “umbrella” and “basket” trials have gained prominence for their innovative approach to targeted therapies. Common Clinical Trial Designs 1. Randomized Trials 2. Open-Label […]
Background: The Hatch-Waxman Act of 1984 The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, was designed to balance innovation and affordability in the pharmaceutical industry. Its twofold purpose was to: The Act established the modern framework for the regulation of generic drugs, streamlining their approval process […]