Clinical trials consist of several stages, each phase comprising several stakeholders who exchange a variety of data related to drugs, patient health, collected samples, etc. This in addition to the exchange of physical material such as drugs, test tubes or bottles, and a medical device and devices, among other things.
The clinical trial process must be consistent with a clearly defined and pre-agreed protocol from the outset. The average clinical trial can take from three to seven years and, therefore, has serious financial implications for the sponsor and the drug company. The Center for the Study of Drug Development in Tufts published an assessment of the high cost of developing and obtaining approval for the sale of a new drug.
Fraud in the process of clinical trials is not unusual, since the ultimate goal of the drug manufacturer is to earn millions from the test drug. Consequently, there is a tendency to reduce the number of processes and accelerate the trial by falsifying data without observing the protocol and procedures.
A huge amount of data is produced and consumed throughout the clinical trial process. This includes statistics on patient and drug health, pathology and radiology, as well as images, surveys, data on medical devices and tools, and safety and quality reports. All these data are spent on different stakeholders, including doctors, doctors, administration of institutions, regulatory bodies, sponsors and the pharmaceutical company itself.
With so many parameters that make up the data supply chain, errors can occur either by mistake or intentionally. Fraud typically involves hiding or misrepresenting critical data points (fake consent forms or modified test results) to speed up the process or save a person. Moreover, the protocol can not be transferred to all interested parties or even can be changed during the trial in favor of a positive result.
Blockchain can play an important role in this data supply chain. From the outset, the test protocol should be clearly defined, and the relevant data should be recorded and simultaneously disseminated to all stakeholders, including audit and regulatory bodies. Being part of the Blockchain network ensures that no aspect of the protocol will be changed later to satisfy one or more parties. As the process progresses, the block chain captures all potentially vulnerable data, whether it be moving drugs, supplies, medical devices or equipment used during the test, or generating and exchanging reports.
Thus, the integrity of the data becomes irrefutable, and the need for such steps as checking the original data becomes unnecessary. The adoption of the block chain and the involvement of all stakeholders in the network, together with the clinical data management system, will further accelerate the clinical trial process and lead to early decision making with zero (or minimal) manipulation capabilities.
Smart contracts can also be used as “paid gates” to check the completion of the phase before the next stage begins. This can be done in all three phases of clinical research and can also be used between phases at certain stages.
To summarize, the block is a great opportunity for the clinical trial process – directly from the protocols of test reports and protocol amendments – to capture all data streams at various stages of clinical trials, right up to the moment when the test passes to the regulatory approval phase.
Using Blockchain in this process will not only make the process transparent to patients and all other stakeholders, but will also increase efficiency, shorten the length of the test period and increase reliability while maintaining safety and confidentiality.