Nowadays digital data is everywhere, in every sector of the economy or the industry. Every Organization and user of digital technology is generating trillions of data nearly every day.The ability to store, aggregate, and combine all these data and then use the results to perform deep analyses with the help of very complex algorithms has become very common in all sectors. The banking sector is very active in this area as there is a huge amount of money to be saved. They are able to follow the usage of credit cards around the world and make sure that it is always the owner who is using it.
Two elements helped the hatching of the treatment of big data. The first one is the size of the storage capacity (from the first hard disk built in 1957 having 5 Mo of capacity to the actual ones which start to be in To). The second element that helped to increase the capability of calculating more and more complex algorithms is the evolution of the microprocessor (form the first Intel chip 4004 built in 1971 to the actual Pentiums and its x cores) Both elements together, amongst all others, gave us the possibilities to have apps like translation in real time, facial recognition and many more.
The only industry lagging a bit behind all this is the pharmaceutical industry. And although they claim to be very innovative, which in fact they are by inventing new molecular entities to cure very complex illnesses, but in the development phase of the drugs they are really behind the other industries.
Knowing that clinical development is the sector that is mostly based on data handling, it is very difficult to understand why this industry is taking so long to profit from the amazing possibilities offered by digital technology. Even the major players in IT like Apple, Google, IBM, Samsung and many others have started to develop tools for doing clinical trials. We would have expected these initiatives to come from the pharmaceutical industry first.
In clinical research the global mindset is still focused on paper. We have done this for so long that we cannot think outside the box and define new ways to handle all the data we need. It’s almost though the industry is afraid to step into this new universe. But we should all be very excited to move forward with technologies that could help us to develop new drugs safely because we could watch the progress of our studies. It would be very beneficial for our patients if we could detect very early if there is any problem.
What’s more, it would also help save costs if we could foresee and better plan recruitment, site selection, drug distribution and so on. The potential in saving costs by using emerging technologies could be enormous and hugely beneficial to the industry.
A police department in Memphis, Tennessee, for instance, implemented a predictive analytic tool for crime prevention back in 2005. As a result, the crime rate in Memphis dropped by more than 30 percent. Adopting such a concept and implementing it in clinical trials is by no means far-fetched. It is possible to collect all the data you have on file, analyzing it to extract trends and use it to develop an algorithm that could predict the events.
In clinical research we mostly work in the same therapeutic areas. We collect an amazing amount of data (some even ask themselves why we need to obtain that much data) and yet we ignore most of the information hidden behind it. I’ve always held the belief that the data we collect every day is our most precious asset. We have to analyze them, not just to find out the efficacy and safety of our drugs (which I agree is the basis of our business) but also for all other information we can find.
We can definitively extract information about the flow of drugs and material we ship to investigational sites while finding out why sometimes we are not efficient enough in this aspect and at times suffer stock outs. We can analyze where are the best recruiters and if they are available for taking new studies on board. We could even predict, based on the historical data on file, if those site will recruit and how it will take them to get the number of patients needed.
I remember a quote from Dr. Fergus Sweeney from the European Medicines Agency who said, "Most, if not all, that is described is already within the scope of existing legislation and guidance, change preconceived ideas, ingrained practices. Technology and ideas are there…. practice is lagging behind. So even the regulators are expecting us to go forward and make a better use of technology."
I am fortunate enough to work in a company where the head of clinical development, Dr. Vas Narasimhan, recently said in an interview to the magazine Nature: ”how much we can learn about the quality of our trials on an ongoing basis by really careful monitoring and by trying to create predictive algorithms that can look at a set of factors in a trial and warn us if quality might need to be addressed”. I think we should have more senior managers with this kind of mindset.
The future is certainly for those who have the courage and the intelligence to implement all these new features that the digital world brings to us. I don’t think there is much to invent (they do it for us) let’s use what is already available.