A properly designed clinical trial forms a necessary part of successful drug development. To design and execute an efficient trial necessitates understanding collaboration and esteem of a multi disciplinary team. Recently I came across a book, ‘A Quick Guide to Clinical Trials’. The book investigates the fundamentals of studies and to familiarize the anyone new at the basics of clinical trials . Aimed at imparting a company foundation of its drivers, the studies process, checks and balances and more, this publication sets out to provide a perspective of clinical trial process.
The follows a follows a jargon lite manner of presentation which you may build upon later as possible, Further, since it is hard for experts to keep abreast of current developments each chapter acts as a fast review of the clinical studies process, its own drivers, checks and balances.
The book’s 14 chapters have been categorized into the future, namely overview, nuts and bolts, and 3 sections. The Broad Overview explains the meaning of clinical studies, covers a brief history of the FDA and clinical studies, and delves into the company facet of pharmaceutical drug development.
The one other thing I learnt about clinical trials is that there are more than 53 documents that need to be filed during a clinical trails process. The breakup is around 20 documents in pre-clinical, 25 in Clinical and 8 after the clinical trials are over. These form a core part of the Good Clinical Practices (GCP).
Some thinkers feel that Blockchain could be a solution to keeping track of the clinical trials process. For those unfamiliar with this term, Blockchain is a continuously growing list of records, called Blocks, which are linked and secured using cryptography. Each block contains typically, a link to the previous block, a time stamp and transaction data.
If we look at a Clinical Trails process, it would benefit immensely from Blockchain adoption. But I don’t think we are ready as yet and there are some pilots working on Blockchain, industry adoption may take some time.