Application 1: Clinical Trials

Issue

When it comes to the pharma industry, clinical trials have been designed in order to examine
the tolerance level & efficiency of any drug or medicine on a number of patients to prove or
disprove a particular hypothesises. Generally, such a process takes many years and its results
are crucial for the future use of the medicine or drug. Pharma companies & their sponsors have
been investing billions of dollars in these tests and under such circumstances, any result which
is non-conclusive could have huge financial implications. Because of the importance of these
outcomes of clinical trials, these trials are susceptible to frauds. But it is difficult to know how
regular it is. Obviously, those who are enagaging in such frauds are unlikely to accept what
they did. Also, this issue is generally under-reported.

During clinical trials, a huge amount of data is generated such as safety & quality reports,
medical reports & statistics, surveys and blood test reports. Also, a large number of people are
involved here, which makes it difficult to be able to track everything. Therefore, some errors
are likely to happen unintentionally or not. Frauds generally entail either altering or hiding any
data that can potentially affect the advancement of any clinical trial & can also damage the
goodwill of any such organization in the eyes of regulatory bodies or even patients. Various
sorts of data could be altered or manipulated.

Firstly, any trial needs to be designed carefully in the context of making a hypothesis, research
procedures & data storage techniques. Such information is generally not made available before
the start of a trial. This allows the members to alter some protocols to ensure a desired outcome.
Later, all the patients participating in a trial need to give their consent. These consent forms
that could be left either incomplete or even faked if the scientists are not successful in getting
their consent. Also, during the trials, patients often have to take certain biological tests and fill
some surveys in order to track the progress of their condition. But this data that has been
collected from these patients and the data that had been mentioned on standardized forms could
be very dissimilar. Generally, these reports are compared to these participating centers to
identify varying data. However, this kind of fraud is uncommon, specifically in trials that
happen in particularly one centre.

Solution through Blockchain

Blockchain could deliver proof-of-existence for any and all documents & can also aid anybody
in validating the legitimacy of any such document. For adding any new data in the form of
transactions, it is important that the majority of nodes approve its validity and it should also be
consistent with the history of that blockchain. Therefore, alteriing current information will
require modifying the archives of the majority of computers that are part of the network, which
is very difficult.
This particular feature of blockchain is indeed very powerful when it is applied to clinical trials.
Also, data is often changed or manipulated currently there is no system to prevent it.
A study has been led by Dr. Irving & Dr. Holden in which they have explored that how
blockchain can be potentially used in order to deliver proof-of-existence for the purpose of
clinical trial data & allow anybody to verify the same. For the data to get kept on the blockchain,
data from a particular trial has to go through a SHA256 calculator which runs a hash that is a
unique code pertaining to the specifics of the document (such as trial procedures, biological
tests, Consent Forms etc). Any minor change in the originally existing file can lead to creation
of a totally different hash. While making use of a bitcoin wallet, both public & private keys are
generally provided.

This public key shows that a particular document had been recorded on the blockchain at a
particular time. Now, if throughout the trial, somebody has uncertainties about the validity of
the data they come across, they can easily confirm whether this information that they have is
comparable to that original information that was kept on the blockchain. To be able to do this,
that person will have to process the data that they have via the SHA256 calculator & match the
public and private keys which have been generated. In case the newly generated keys are
indistinguishable to the original that are on the blockchain, it basically shows that the data was
not changed or modified.

Since blockchain decreases the risk of any kind data fraud significantly, dependable protocols
& results can be issued which facilitates the duplication of such a study and also ensure
collaborations in the scientific community.