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.
(Photo by freestocks.org on Unsplash)
Hello Sir,
Wonderful and informative article. MedRunner is exploring the unity of CROs and blockchain .
We will welcome for insights and mentorship.
Founder http://www.medrunner.in
Hi Jyoti Prakash
Good to see you are working in this emerging space. I am unable to open your URL, Please drop me a note on drvikram@healthcare-in-india.net.
very interesting article.
Thank you Sidharth
Clinical Trials are an area looking for a tremendous uptake in technology and adding Blockchain to the mix definitely is an area well defined in your blog. Highlighting the process in the clinical trials, as you have done in your article provides a direction to how the technology needs to be included into the clinical trials workflows.
Gartner have included Blockchain as part of the Digital Platforms Trends in 2017 report, “Digital Platforms – With bitcoin and Ethereum constantly in the news, blockchain might seem like it’s just around the corner. However, most initiatives are still in alpha or beta stage. Enterprises are still deciding how to navigate this technology, but the lack of proven use cases and the volatility of bitcoin have created concerns about the viability of the technology. Long-term, Gartner believes this technology will lead to a reformation of whole industries.
Of the two types of blockchain — permissionless-public ledgers and permissioned-public ledgers — enterprises should look toward the latter option. Permissioned-public ledgers have access controls owned/managed by rules, but still allow for a community”
(ref: http://www.gartner.com/smarterwithgartner/top-trends-in-the-gartner-hype-cycle-for-emerging-technologies-2017/?es_p=4756355)
Dr. Vikram, Look forward to more insights from you as the technology adoption happens.
Hi Manish
I agree with you. The low hanging fruit in pharma is tracking drugs. Systems like e-pedigree in the US already use a form of permission enabled distributed ledger enabled through RFID. Now FDA is considering Bloackchain for the same.
Hello Sir Nice Artciles
Please review our Article also
https://www.techracers.com/blockchain-clinical-trials
https://www.techracers.com/clinical-trials-blockchain