How can BlockChain help in Clinical trials being conducted in India?
By Prisi Kumar
Written solely by the student, Devansh Bhatnagar, who is responsible for all the glory and the pitfalls of the write up. This was part of citizen science effort under the leadership of Sukant Khurana
What is Blockchain ?
We will try explaining block chain in layman’s term, we can consider block chain as a digitalised medical record. Every record is a block which has a label stating the date and time when the record is created. We all knew that the medical history is important for diagnosis so it should be made non modifiable by anyone once the record is created. Patients will be accessing the records and doctors will be creating medical records with their special privileges, block chain works in similar way which makes it both accessible and secure.
What is clinical trial ?
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. If a drug or medicine is found it has to pass through several clinical trial tests before it goes into the market. Lets take an example if the drug for Alzheimer disease is found, it has to tested on numerous people. These tests will be carried on people who join as volunteers and they will be explained about the risks and benefits of the particular clinical trial. Clinical trials will be conducted on different phases with different objectives. The below picture will demonstrate the different phases of clinical trial performed for Alzheimer disease.
Challenges in clinical trials
Clinical trials are sponsored by some companies so that the volunteers will get paid and amount will be spent for lab and other expenses also. If the volunteers are leaving in between the trials they need to get new volunteers for clinical trial this will lead in excess of cost and time so this has to be planned.
The number of clinical trials being conducted saw a drop since 2013. Only 19 trials were approved as compared to 260 in 2012 and 500 in 2010. This was due to Supreme Court intervention which noticed as many as 2,262 people died in India in the clinical trials during the past five years. Consequently court ordered to regulate the clinical trials stringently and ensure safety of the patients. Safety of the people is another very important challenge in clinical trial.
How blockchain can overcome the challenges in clinical trials?
At clinical trial level
Blockchain technology can act as a SafeGuard for the complex and wide range of actors required in clinical trials. In practice, the proof of existence for consent will be timestamped and stored in Blockchains, enabling clinical research stakeholders, such as sponsors, investigators and IRBs, which can be numerous in multi-center clinical investigations, to share consent and re-consent related data in real-time, and archive and historicise consent sets, which can be matched with each revision of the protocol.
Obtaining consent must be a ‘lock’ before subject inclusion in clinical trials. Indeed, with the help of Blockchain cryptographic keys, investigators won’t be able to include a patient in the trial until their consent is collected. In addition, to ensure a strict parity between enrolled patients and included patients, the present study will use one core functionality that Blockchain enables: the Smart Contract. This is a piece of code that holds a programmatically written contract between as many parties as needed, without any third-party, which executes algorithmically according to the terms provided by the contracting parties. This makes it possible to build a Smart Contract that will be executed with the only condition that patients will only be included when the enrolment is complete (technically, every Blockchain transactions can have a lock associated to them and transactions can be pending and triggered at an agreed upon contract time).
At people level
Block chain will help in having data transparency at all levels of people. So even the people can track the amount of drug and other data added like the doctors.
References :
https://catalyst.nejm.org/decoding-blockchain-technology-health/
(https://en.wikipedia.org/wiki/Smart_contract, version of 2016.09.05).
https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies
https://www.alzheimersresearchuk.org/our-research/what-we-do/big-initiatives/clinical-trials/
