10 Professionals Predict the Future of Clinical Trials

10 Professionals Predict the Future of Clinical Trials

Xtalks journalist Candice Tang interviews Imran Chaudhri, Chief Architect for Healthcare and Life Sciences for MarkLogic at DIA 2019.

Developing new drugs is a slow, costly and labor-intensive process, but cutting-edge technologies offer the promise of streamlining the process in a way that’s never been done before. The pharma industry is also approaching clinical trials in a more thoughtful and connected way, putting a greater emphasis on the goals and desires of the patients and families involved. 

As the healthcare industry approaches a new age of trials, Xtalks spoke with 10 professionals gathered at the Drug Information Association (DIA) Global Annual Meeting 2019 in San Diego, CA, to get their take on what the future of clinical trials holds. Here’s what they had to say: 

Michael Kleppinger, PhD, MBA, Executive Vice President of Clinical Market Development, Syneos Health

“The future of clinical trials obviously has to be directly correlated to increasing patient care, migrating from a standard of care to a better service level for our patients irrespective of the therapeutic application.”

“Data obviously is very prevalent in our industry and becoming much more accessible to all of the different constituents within the industry. It’s all about how we convert that data to actionable intelligence. As you can see here at DIA this week, there’s a lot of focus and companies that are working to bring those insights to both patients and clinicians which is important to us all.” 

Bryan Clayton, Vice President of Strategic Solutions, YPrime 

“Clinical trials are getting more and more complex. We’re seeing things like master protocols, adaptive trial design, basket design… the more we see these types of trials, the more we have to allow our technology to support them. What we’ve seen is that simple technology needs to support complex trial designs, and that’s where I think the industry will continue to go.”

Lisa Dilworth, Vice President of Rare and Orphan Disease Drug Development, Synteract

“I think the future of clinical trials is really exciting right now, it’s going to be a lot of engagement with multiple stakeholders. We’re pulling in patients earlier than we ever have to make sure that they have the endpoints that they want and making sure we’re capturing what’s meaningful to patients. That’s happening a lot sooner, and it’s happening across all different drug development programs now.”

“We’re also working closely with regulators around the globe to make sure that we are all aligned and that we are developing programs that can be successful and meaningful.” 

Janine Jones, MBA, Clinical Solutions Specialist, BioClinica

“There’s a lot of competition in the arena which breeds a lot of success that’s upcoming for the clinical trial world, especially electronically. In my job, demo our software offerings and one of the things that the clinical trial world needs is interoperability, instant access to data no matter where you are in the world, flexibility of platforms and an electronic platform that makes it easy for clinicians, investigators, sponsors to do their jobs.”

 Ken Light, Executive Vice President of Corporate Strategy, OmniComm Systems

“There’s a great deal of change and transformation going on right now in clinical trials as organizations try to become more effective and efficient. The changes are both in the way the business runs clinical trials and in the technology.”

“From a business perspective, organizations are spending a lot more money and investment in late-phase clinical trials. They’re basically trying to take the drugs that they’ve already brought to market and find new uses for those drugs, new indications and do safety profiling on those drugs. Within late-stage, you see things like risk-based monitoring and better approaches for monitoring of the data. We see a big focus on real-world data and real-world evidence pulling data in from genomic databases, from pharmacy databases, from clinical systems, from electronic health record systems, all to try and find meaningful value out of the drugs and the capabilities that exist today.”  

“Another thing is virtual trials. There’s a whole push to try to expand the potential patient population and make clinical trials available to everybody including people that don’t have easy access to a clinical site.” 

Joe Ehrline, MBA, Vice President of Sales, Saama Technologies

“My personal take on the future of clinical trials is on harnessing the data that is out there in clinical trials. Right now, so many companies are struggling with how to incorporate all this data from disparate systems and be able to use that to make business decisions. If you think about it, if you’re only getting partial data, be it from a CRO or EDC system or CTMS system or your financial systems or wherever that data is housed and sitting, how are you able to make informed decisions on partial data? In my mind, it’s like trying to throw darts with a blindfold on. These are decisions that are going to impact the outcome of your trials, it’s going to impact drug development and ultimately it’s going to impact us bringing therapies in need to the patients that are out there.” 

Patrick Hughes, Chief Commercial Officer, CluePoints

“What we’re seeing is the industry is much more amenable now to looking at data in different ways to enable different decisions to be made in a timely manner. What we’re going to see in the future is a lot more decision-making and knowledge based on the types of data analytics and data acquisitions that’s being undertaken.”

“But how the data is collected and ingested into systems like CluePoints to do analysis, we figure that’s going to change an awful lot in the future as well. There’s going to be data acquired from Fitbits, from devices, iWatches, all streaming into databases. The analytics are going to be a big part of how clinical trials are run in the future.” 

Sarah Ikard, MBA, Senior Director, Business Development, ICON plc

“I think the future of clinical trials is really patient-focused. We are doing a lot of stuff with wearables and tracking patient data outside of the clinics. So, when they go home and use the product it’s tracking how the product is working and if they’re feeling better. I think that’s a big focus area right now.”

Mike Nolte, MBA, Chief Executive Officer, Signant Health

“It’s going to be largely a fairly slow evolution towards broader participation of using technology as a lever. There’s a lot of buzz in the industry around siteless trials, or hybrid trials, or virtual trials. I think that progression will be relatively slow, but I do think that through technology, through video interaction, through devices collecting data, through the ability to provide services to somebody outside of a traditional site creates the opportunity for more people to potentially have access to life-changing research, but also creates an economic benefit for the sponsors that are running clinical research in the first place.”  

Imran Chaudhri, Chief Architect for Healthcare and Life Sciences, MarkLogic 

“Clinical trials are evolving in a lot of interesting ways. One is that clinical trials used to be very manual, very intense on the paperwork and administrative process of the system, and a lot of clinical trials had to be developed very specifically for the drug or disease of interest. These days, you can start combining physical clinical trials with virtual clinical trials, so being able to do retrospective studies on clinical data that’s been gathered over the years and combine that with your real clinical trials to get better insights. You can also take the data that you’re bringing in and run it through machine learning algorithms to get projections of predictions of how well certain molecules will work, as well as predictions on toxicology and how effective or ineffective the various treatments will be. 

As the drug industry continues to advance its efforts to modernize clinical trials through new methods, regulations and technologies, sharing knowledge across the industry about what works and what doesn’t will be paramount in the future success of clinical trial execution.