Blockchain-related applications developed or planned in the healthcare sector are numerous. Decentralization, reliability, and transparency of data are all elements that make this technology a revolution for the industry and for healthcare professionals, but also for patients. Our team dedicated to Healthcare studied the impact that the Blockchain could have on an often-decisive moment in the development of a medical device or pharmaceutical product: the clinical trial.
Blockchain in Healthcare: a simplified patient recruitment
A clinical trial is a long and expensive process, partly because of patient recruitment. Thus, it is observed that approximately 2/3 of clinical trial sites do not meet their initial recruitment targets. Blockchain can aggregate trial and patient data anonymously or by requesting patient authorization beforehand. Recruitment would then be facilitated.
In addition, the Blockchain allows real transparency in the use of patient data. They then know for what and by whom they are used. Thus, sponsors and sites can reassure some patients who are reluctant to participate in a clinical trial.
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A lighter administrative procedure thanks to the Blockchain in case of protocol modification
The Blockchain can also intervene after the recruitment of patients. To ensure the validity of the trial as well as the validity of the results, it is common to modify the clinical trial protocol. This requires the edition of a new consent form: an administrative burden which, if improperly executed, may call into question the validity of the test. Thanks to the edition of “Smart contracts“, it is possible to automate the process for each change of protocol.
Unparalleled data reliability thanks to the Blockchain
Several studies have highlighted the difficult reproducibility of clinical trials. Many of the trials are not replicated, and when they are, they may not obtain the same results as the original clinical trial. Data entry errors, voluntary or not, by the multiple actors who handle the data are partly responsible for this phenomenon. The Blockchain is an extraordinary tool to solve this problem.
Indeed, the data stored there cannot be modified and are arranged in a strict chronological hierarchy. The consistency between the data and metadata of the clinical trial is thus reinforced. In addition, data, protocol, and past protocols are all kept in memory and verified when new data is integrated. This greatly limits the risk of data entry errors or even of under-notification of adverse reactions.
A transmission of information between the stakeholders optimized by the Blockchain
The actors involved in a clinical trial are extremely numerous and perform heterogeneous tasks, which require different access to data. For example, statisticians, in charge of planning and carrying out statistical analysis, are involved. There are also sponsors, researchers, regulatory authorities, etc. With the Blockchain, information is brought together in one place. Each party is assigned a key that will allow them to have access only to the data they need. In particular, the use of Blockchain would be a way to simplify the validation of the clinical trial by regulatory authorities. Whether it is to prove the source or to demonstrate the integrity of the data collected, this way of storing information can only optimize this process.
By facilitating patient management, making the data obtained more reliable or optimizing communication between the actors involved, Blockchain is a technology that could considerably reduce the weight that a clinical trial represents for manufacturers. And the outlook is promising! Even if these applications are for the moment only theoretical, several organizations are currently trying to develop the necessary infrastructures to set up the Blockchain in this area.
About the authors
Grégoire, Consultant, Emile, Business Developer and Delphine, Business Unit Director in Alcimed’s Healthcare team in France
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