The Medical Writer

INVESTIGATOR'S BROCHURE IN CLINICAL TRIALS The Investigator's Brochure (IB) serves as a resource for clinical trial investigators. It highlights the key components of a product's development to date. It reviews nonclinical and clinical findings. It suggests ways to study the new product's benefits and dangers. Regulatory Guidance on Structure and Content Section 7 of ICH E6 lists the highest-level sections as follows: Summary Introduction Physical, chemical, and pharmaceutical properties and formulation Non-clinical studies Effects in humans Summary of data and investigator instructions. When researchers conduct the first human clinical trial, they require an IB. According to ICH E6, a team should review an IB at least once a year and revise it when necessary. However, the team may increase the frequency of revisions based on the development stage and new relevant information. The Six Main Sections of an IB Summary This part summarizes the next sections. It profil...

INFORMED CONSENT FORM IN CLINICAL TRIALS Informed consent protects individuals who participate in clinical research. Its primary purpose is to promote independence and protect the well-being of participants. FUNDAMENTALS OF INFORMED CONSENT 1. Voluntarism  Voluntarism is a person's ability to make independent, unforced decisions that are compatible with their goals, circumstances, and prior experiences. Factors that may impact voluntarism include:    Logical and emotional capacity to make complex decisions Health-related considerations  Religious and cultural beliefs  Financial burdens and caregiving responsibilities 2. Information Disclosure   Information disclosure means providing patients with all of the information they need to make an informed decision. This should contain an explanation of their health condition, the study's objective, any experimental procedures used, potential risks and benefits, the nature of the problem, and the like...

THE STAGES OF DRUG DISCOVERY AND DEVELOPMENT  Drug discovery aims to identify compounds that are therapeutically useful in the treatment of diseases. This procedure involves choosing candidates, synthesizing, characterizing, validating, optimizing, screening, and performing therapeutic efficacy tests. Once a compound has shown significance in these investigations, it will initiate the drug development process earlier in clinical trials. The new medication development process must go through multiple steps to produce a medicine that is safe, effective, and meets all regulatory standards. From initial discovery to marketable medicine, this is a long, challenging task. It takes about 12 to 15 years to complete. ·          Identification of unmet medical needs ·          Target identification ·          Target validation ·       ...