Clinical Trials are quite an important factor for pharmaceutical companies. A negative result will be a big blow for the organization and its efforts to build so far. It is time consuming, expensive and involves close collaboration among multiple stakeholders.
Clinical trials also involve a lot of challenges. The most important of all is- data management, data sharing and security, subject enrollment and spiraling costs. Each one involves a lot of efforts. Hence one will need a holistic technology that is more sophisticated to handle these.
Recently, we came across bitcoin, a digital wallet that is aiming to create a currency without borders. What is more interesting is the technology it is being built with i.e. Blockchain. How does Blockchain work? How will it solve the problem of clinical trials? Here is all the information that you need.
What are the Challenges involved in Clinical Trials?
When it comes to clinical trials, challenges are enormous. The first that anyone would say will be complexity due to regulatory announcements. For example, let us say usage of a particular component in one drug is banned all of a sudden in a particular region by one regulatory authority.
Here you may have to see build the process again from the beginning. The strict regulatory decisions will always lead to spiraling costs and patient access i.e. you may be in the verge of beginning a trial and that is when the new regulatory framework jumps in. You may have to make patients come another set of dates. Also, new set of raw materials to produce medicines and get it approved.
Hence the cost spirals and so does your time. Manpower is another big issue. You developed a product with an idea in your mind. This idea shall not essentially be in the minds of your medical product development team.
Hence you need to train them and make them understand so that they can cooperate with you much better. Remote management of team is another big deal. You may conduct clinical trials in different parts of a country.
Being in every single place at once is practically not possible. Hence you need to identify people who can take over your role in each of these places. More than all of this, technology is also cited as a challenge by several people reportedly.
Blockchain is a time-stamped series of fixed data which is not owned or managed by a single entity. Hence it has no central authority and it is open for anyone to access.
Hence by nature everything in Blockchain is transparent and very stakeholder is responsible for the actions. For example, let us say you want to buy a flight ticket. You go to any of the online ticketing platform to book tickets.
The website or the app you book will charge a processing fee and so does the payment gateway. Hence you end up paying extra twice. It could be a dollar here and a dollar there. But every single penny counts. Hence several are now using Bitcoin that is powered by Blockchain technology as these transactions are free.
Moreover, your transactions from one geography to another will take place without much effort as Bitcoin is not barred by Geographical and ethnic boundaries. The scope of bitcoin is turning out to be enormous.
Infact, it is disrupting the way the world functions and could even eliminate banking systems. Even ecommerce marketplaces will be of no use with Blockchain as it can build a transparent, robust and secured system to protect user data. Even sale of e-books online will become easier.
How does Blockchain Work?
Let us say you’re working in a excel spreadsheet that allows access to anyone possible in the network worldwide. So you will make an update in the spreadsheet followed by someone else in a remote location. Likewise, several other people can update the same sheet from remote location.
If you understand this concept, you know the basics of how Blockchain works. Yes, in lay man terms it works the same way.
Decentralization, Transparency and Immutability are the three principles based on which Blockchain was built. As on date, we all are using internet that is connected from all your devices. Now all the data is stored in one spot as it is centralized.
Hence all information is stored in one server and if that server fails or gets corrupt, accessing information turns out to be difficult. Blockchain allows every user to have control over the information they create. Bitcoin is the best example of this. So if you’re holding a bitcoin wallet, you don’t have to worry about banking systems.
You’ll be your own banker and incharge of your own money. Moreover, this is beyond boundaries. If you’re in USA and you want to send money to someone in France.
You can do it through your digital wallet without any pre-requisites. Already several people are using Bitcoin and it is slowly disrupting the financial market worldwide.
How can it solve the issue of Clinical Trials?
The example of what we discussed above on the spreadsheet well explains how it can help clinical trials. Let us say you’re organizing clinical trials in 10 different cities worldwide.
The whole team is either remotely connected or not at all connected. But you all decide what has to be done and carry out the operation. While there is another team which is looking after the trends happening in the industry and updating the team through Email or a common communication thread.
So if there is a regulatory announcement that can impact your clinical trial, at once in all locations you can change the course of the process.
This process will reduce costs and let you go ahead without wasting much time and resources. Your team is well informed about the processes and they know how they are progressing further.
Hence your problem of remote management, manpower, remote location and patient management can all be resolved much well with Blockchain technology.
Various other industries are widely utilizing Blockchain to innovate already. Healthcare with the huge amount of data requires someone to analyze them. But Blockchain can simplify the whole process. Sorting challenges in the healthcare sector overall will be much more simplified with Blockchain.
Also, medical product development as well as device designing becomes much easier with this sophisticated technology.
Aravind Sundaram is a Mumbai based Content Specialist who has spent 6+ years romping around the healthcare, medical device, manufacturing, content and software industries. He is currently a Content Specialist at Technosoft Innovations, Inc. where he documents and presents the latest researches and innovations of the company in the medical devices industry. He enjoys sharing medical device development knowledge and experience via his posts and articles.