Blockchain in Clinical Trials

Blockchain in Clinical Trials

Shaveta Malik, Archana Mire, Amit Kumar Tyagi, Arathi Boyanapalli
DOI: 10.4018/978-1-7998-3295-9.ch015
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Abstract

Clinical research comprises participation from patients. Often there are concerns of enrolment from patients. Hence, it has to face various challenges related to personal data, such as data sharing, privacy and reproducibility, etc. Patients and researchers need to track a set plan called study protocol. This protocol spans through various stages such as registration, collection and analysis of data, report generation, and finally, results in publication of findings. The Blockchain technology has emerged as one of the possible solutions to these challenges. It has a potential to address all the problem associated with clinical research. It provides the comfort for building transparent, secure services relying on trusted third party. This technology enables one to share the control of the data, security, and the parameters with a single patient or a group of patients or any other stakeholders of clinical trial. This chapter addresses the use of blockchain in execution of secure and trusted clinical trials.
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1) Introduction

In biomedical research prodigious challenge is the background fixing methodology issues from the background .Certainly related to wide range of scientific misconduct facets, lock of responsibility, from errors to fraud, concessions the outcome of a clinical study and the quality of undermines research. Clinical trials may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women. In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that that the risks are small and are worth the potential benefits. Blockchain (Zheng et al., 2017) can have a wide impact on clinical research because it allows sharing, caring and tracking for data, it also encoded with the tracking system which is secure and decentralized for any interaction of data and that could occur in the clinical trial context. This lead to more belief in clinical research .A steps towards better transparency on the basis to improved clinical research methodology and develop trust within communities of research and between research and communities of patients. Previously, blockchain known to be for bitcoin (Bonneau et al., 2015) as it is distributed public ledger that record all the transaction of a bitcoin in a conformable and secure way without the involvement of the third party to process payment. It is a decentralized storage of data or ordered records, events which is called blocks. In which every block having the timestamp and linked with previous block. The architecture of blockchain agree for storing the existence of proof of data. As the only of data is the proof of data and believe that this is the exapler shift for the medical methodology of research. Indeed to prevent the posteriori reconstruction analysis blockchain ensures that the events that pursued in chronological order. Blockchain technology is just like a new operating system for belief Indeed in health care (Mettler, 2016)has made substantial treads in the last few years. For example IBM entered into research projects (Brodl, 2019)with the U.S food and drug administration and center for disease control and more recently announced and multi-company health utility network being designed to create an complete blockchain network that can value multiple members of the healthcare ecosystem in a protected, joint environment. The great challenges in clinical trials are sharing of data, personal data privacy concerns and enrolment of patient and Boehringer Ingelheim’s commitment to healthcare innovation and marks the first time that blockchain technology will be explored in a clinical trial setting in Canada.

Blockchain technology as a new operating system for trust (Sawal et al., 2016). This collaboration is another great example of the ways stakeholders are coming together

However, blockchain remains a vague concept with unclear benefits for many in the clinical research and brader healthcare industries.

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