Introduction

Data is core to everything digital. This makes data security of utmost importance, especially when human lives depend on it. And today, an immutable shared ledger powered by cryptography that enables digital agreements called smart contracts is possibly the best Data security technology available for the protection of digital data. Here, we are talking about Blockchain Technology and its applications in Clinical Trials. Data Reproducibility and Transparency are the two major areas where Blockchain implementation can help.

Problems with the Current Clinical Trials Process

The success of pharmaceutical companies depends on their newly researched drugs successfully passing the clinical trial process. These brands put heaps of money in the research process of the drugs and are under immense pressure to make sure the drug clears the trials. It is because of this reason, some of them try to influence the methodology followed by the clinical trial companies to produce results in their favour.

Rectifying the methodology issues is one of the great challenges in clinical research. Often, lack of reproducibility related to a wide range of scientific misconduct aspects, from errors to intentional falsification of data, compromises the outcomes of a clinical study and weakens research quality. The process involves taking consent from the patients, recording them, and then sharing it with investigators, the review committee, and sponsors. Currently, the methods available to perform these tasks are prone to errors and alternations.

How Can Blockchain Help?

The main reason behind the lack of reproducibility is the inability to store the data inputs in terms of

• Sequence
• Parameters
• State of the subject/environment/drug
• Quantity of the test subjects
• Standardize format

so that it will produce the desired output always, given the same data inputs. Blockchain can do wonders in this regard. It can record the whole process, by preserving every minute detail in a step-by-step manner with a timestamp on an immutable shared ledger. The data integrity is taken care of by cryptographic validation to eliminate any falsification of data.

The complete study protocol including the probable test outcomes and the planned analysis is saved in the form of a text file and fed into an algorithm known as SHA256. These can be only viewed by authorized users that include patients, investigators, reviewing authorities, and investors. After each of them gives their consent, their proof of consent to the study protocol and the protocol itself is recorded immutably on the Blockchain in the form of smart contracts.

This ensures that all the probable test outcomes have been accounted for. In such a scenario, it becomes compulsory for the research report to have all the information and any missing links/alterations can be easily pointed out. Since the results can’t be altered, the clinical trial organizations are thus bounded to produce complete results about the probable test outcomes and the planned analysis. This is how Blockchain can impart much-needed transparency to the whole clinical trial process.

Current Status of Blockchain Adoption in Life Sciences

According to a survey done by Pistoia Alliance, 60% of pharmaceutical/life science companies are either using or experimenting with Blockchain in 2018. Out of the companies surveyed, 55% think that the lack of skilled Blockchain professionals is one of the major barriers to adoption. Not only life sciences but there are also many independent Blockchain-based projects being developed for recording and sharing medical records.

Conclusion

Blockchain technology has opened up new doors in clinical research by structuring a more transparent, auditable process. It can secure clinical trial integrity and can result in the community-driven Internet of research data, gathering researchers and patient communities in a decentralized ecosystem, which can lead to more secure and transparent clinical research analysis.