An interesting element of every DIA annual meeting is the variety of voices that are brought together from across the drug development ecosphere. From industry to regulatory bodies, academia, and even students, diverse backgrounds and experiences are brought to the table.
The cumulative effect is that you get to hear many different perspectives and insights, and view challenges from different angles.
Opening the door to technology in clinical trials
A clear example of this mix of views was prominent at an afternoon session called “Technology-Enabled Clinical Trials Using Electronic Health-Records Derived Real-World Data: Opportunities and Limitations.” This session examined how technology can make clinical trials more accessible, diverse, and efficient. The panel included experts from the clinical trials industry, the FDA, and academia/research sites.
For me, the session exemplified what I wrote about in my previous blog post (Opening Day at DIA Meeting: Two Clinical Trial Approaches Join Forces). Specifically, I mean the different forces pulling at the industry. One force is the post-pandemic re-opening of traditional research methods. This includes the nuts and bolts challenges that come with it, especially in today’s global climate.
The second force is technology and the innovation being brought to the industry in the way that we discover, plan, execute, and commercialize new therapeutics.
At the technology session, those forces came through in the voices of:
- Kent Thoelke: a futurist and innovator (representing the progressive industry viewpoint)
- Donna Rivera: a member of the FDA, the leading regulatory authority which is struggling to provide oversight over the blending of the old and the new (representing the regulatory viewpoint)
- Stephanie Graff: the end-user, or what we might call the front lines, which often have to bear the brunt of technology adoption in the real-world setting (representing the research site’s viewpoint)
Change is needed and expected
One of the most compelling arguments and voices came from Kent Thoelke. Kent is an industry consultant and the former head of clinical innovation at ICON. He is an outspoken advocate of the need to significantly change the ways we conduct clinical trials.
Kent always captures my attention at conferences. During this session, he spoke compellingly about our industry compared with other industries. He has previously shined a light on the fact that big tech is driving change and creating new expectations. The general public is enjoying innovation in the ways information is shared, products and services are delivered, and customer service is provided.
He drew stark comparisons between the antiquated, heavily regulated, slow-moving drug development industry and the rest of the world that services consumers. These technology companies and their market capitalization are now starting to dwarf those of big pharma.
The consumer experience
Consumers are increasingly developing expectations based on the services they are receiving from those companies. These expectations ultimately frustrate them when interacting with our industry on their own health care journeys.
Today’s consumers can enter information online and receive a comprehensive report on their ancestry. They can log onto a website and get a detailed report on their credit score history.
The consumer’s car mechanic can run a comprehensive diagnostic check on a car engine and generate a report in a half hour. The consumer can apply for a mortgage online and get immediate approval. Consumers can order a product and have it delivered to their house or put in their garage with photo evidence of delivery within 24 hours or even the same day.
This is what our industry is up against. For example, consumers will not be OK much longer having to wait three weeks for their lab results. When consumers change doctors, their doctor must fax documents and health records to another provider who then has to enter it into their system. Consumers are not going to continue to wait for these things.
Big tech is watching
Big tech will have the capability to buy into our market. They could purchase pharma companies. Or they could do a complete run around big pharma by spearheading new ways to bring new medicines to market using technology. This is not a matter of if—it’s a matter of when.
Kent drew a comparison to banking. He pointed out that it is rarely necessary to go to a bank. Previously, if you wanted to make a deposit, you went to the bank, filled out a deposit form, signed the back of the check, and gave everything to the teller.
No more. Instead, you sign the back of the check at your house, take a picture of it using your banking app, and the bank deposits the funds electronically for you.
People today adopt. They try new things when they understand the convenience it brings to their lives. And they never go back to the old ways.
Why is technology in clinical trials taking so long?
Neal Meropol, the moderator, asked Kent why change is taking so long in our industry. Kent said a lack of will is preventing our industry from making the leap. “We have to get out of this excuse-making and blaming the FDA,” he said. “If we have a question, let’s ask them. We have all the data we need to justify moving forward. The same individuals that seem to stand in the way of adoption are the same people who would not accept going to their bank and having to deposit money the old-fashioned way, with filling out a slip and so on.“
Donna Rivera, FDA associate director for pharmacoepidemiology, said more volume and more evidence are needed. The FDA needs more information on trials where remote data was collected, which includes remote trials with remote monitoring telemedicine, and studies that allow patients to visit nontraditional site locations.
This will all go into the FDA’s understanding and their ability to develop models for approving such methods and trials.
Rivera had cautionary tales. For example, she mentioned studies that lacked factual data and evidence when the data was peer-reviewed. Technology in trials is going to be a blend, she said, and we need flexibility in the way that we conduct studies while rigorously protecting patient data and safety.
Getting around the red tape
A pharmaceutical company employee in the audience spoke up. He stated that one way his company will get around the bureaucracy, extended timelines, and regulatory requirements of the U.S. will be to go elsewhere. He said that outside of the U.S.:
- More treatment-naive patients are available
- Strong clinicians are enthusiastic about being involved in clinical trials
- The use of technology is more accepted
- Trials are enrolling faster
- Data is collected and processed more efficiently and accurately
Given all that, it’s just easier to go outside the United States.
Kent Thoelke pointed out that if we just invested more in community practices and the infrastructure, we wouldn’t need to go to 20-30 countries around the world to conduct studies. With only 3-5 percent of individuals in the U.S. participating, imagine what bringing research into community practices would do.
The sessions I attended were excellent, and this one was a standout. I welcome your thoughts on this timely subject. Please scroll down to enter your comments below.