‘The magic balance’: Diverse advisory boards guide clinical trial design
Datacubed Health, a commercial offshoot of The Human Data Project at New York University, appointed members from a range of fields and varying backgrounds to its Science Advisory Panel. The board includes MIT faculty, a leader of the US Human Genome Project, and also video game designers and neurologists.
Advisory boards like that of Datacubed’s, are working to try to establish a new way of conducting and designing a clinical trial in a way that is suitable for the broad range of individuals that will be participating in them.
To understand the role of this diverse boards and how clinical trials can be influenced by them, we spoke with Alex Pentland (Pentland) and Aristides Patrinos (Patrinos) both members of Datacubed’s Science Advisory Board.
OSP: What are some ways in which a scientific board can benefit a company within the pharmaceutical industry?
Patrinos: The scientific board is composed of individuals with many different backgrounds and experiences, like my own scientific trajectory over the last few decades, and a lot of these individuals on the advisory committee bring in individual and sometimes different perspectives about how some aspects of clinical trials should be put together. Therefore, [these members] can add tremendous value to multiple dimensions of clinical trials by drawing from their individual experiences in various fields of biology and medicine.
Pentland: You need to have people from all different viewpoints of science to get good general science. And that general science can impact the study, because we know these little tiny islands of knowledge if you give this drug a little bit more than you get a little bit more of X, Y, Z. In fact, every little island of knowledge was tested on a limited range of piece, and there’s a great deal of area that we don’t know.
Most of medicine is based on these very finite, and laboratory tests and they don’t know how all the other stuff interact. That’s why there’s such a thriving industry in alternative medicine because people really haven’t covered the ground between the clinical trial and the lifestyle. So, what this offers is the ability to be able to really put some of that in perspective.
OSP: How does working with people with such varied backgrounds benefit the designing of a clinical trial? Would you like to see this continue in the industry?
Patrinos: In the past few decades, many of these different or even conflicting elements of the scientific community generally avoided because it wasn’t very comfortable, but I don’t think we can afford that anymore. It’s very important that we engage, and even though sometimes some of these interactions can be heated, can be difficult, we need to push to make sure there is this dialogue across the varied applied scientific domains. Because it’s in those instances that we would have the most significant accomplishments.
Even though there are obvious risks in engaging different communities which can sometimes create a certain amount of acrimony, the net result is those deliberations can lead to closure and common agreement, and then the net result would be tremendous.
OSP: Part of the role of the advisory board will be to guide trial design, what are some trends you’ve been seeing in design that you feel the board could advise on?
Pentland: [The industry is] looking for something to really change the game. One of the things that could really change the game is incorporating behavior into medicine. If you actually listen to conversations about medical treatments, it’s all about protein levels and all these sorts of biological things occurring in the body.
The actual behavioral variables, what the people eat, how much exercise they get, etc., rarely come into the conversation. This hasn’t really been part of the science so now we’re beginning to take the more behavioral stuff and add it to the biological stuff, and that’s something that people in the drug industry are beginning to think about but it’s new to them. So, this is a trend but it’s a really early stage trend.
[We are] giving people a map about how all these variables interact generally which allows you then to design precise clinical trials much more efficiently and accurately.
Patrinos: The whole field of medicine, especially with the very recent revolution in personalized medicine is really changing many of the paradigms that we have had for many many years. Systems that have worked okay with us, but now with the developments and infusion of significant new elements such as artificial intelligence and deep learning, there are needs to try to improve or adjust many of the ways we did clinical trials in the past.
So, advisory committees, such as the one that Datacubed has solicited, bring in some of those new concepts that could significantly improve the setup and the operations of clinical trials.
OSP: How can combined expertise ideas derived from the scientific advisory board, like that of patient engagement techniques impact a clinical trial?
Pentland: Well, when you’re making a map you want to know what should be on the map, and the directions for the map, so you need people who know about all those different directions and features. It wouldn’t be very good to make a map with people who don’t anything about space but now a lot about water.
The point is, a map can incorporate all the things that matter, even the general ones. To give you a sense of where you are and where you’re going. To include all those perspectives you have to have experts in all those perspectives.
Patrinos: This ability to combine very high tech capabilities with very deep sensitivity and awareness of the personal aspects of individual patients. This magic balance that’s so important for a successful clinical trial.
Tapping and using the most cutting edge tools that we can have to get the most important data and derive the most relevant results that can have an impact on advancing medicine.
It’s a case of making sure you stay on the soft side of things. The soft side is the most important, while at the same time tapping and exploiting the emerging hard side’s capabilities like AI and deep learning.
OSP: Do you foresee scientific advisory boards enabling successful clinical trial design and patient engagement in the future?
Pentland: It’s really something that has the potential to be important, creating a roadmap for health and medicine.
Patrinos: I certainly hope so.
Alex Pentland directs the MIT Connection Science and Human Dynamics Lab. He also previously workedto help create and direct the MIT Media Lab and Media Lab Asia in India.
Aristides Patrinos is a former leader of the US Human Genome Project and a senior official in the US Department of Energy. He currently serves as chief scientist, director of research and as chair of the Science Advisory Board at Novim.
