Applied Clinical Trials
A look at the opportunities and challenges around patient-centric trials and patient centricity in pharma.
At DIA in June, I moderated an executive roundtable for Parexel, which the CRO sponsored around the topic of patient centricity. Specifically titled, “Collaborate to Innovate for Patient Centricity in Pharma,” it wasn’t just about patient-centric clinical trials-we discussed numerous opportunities and challenges around patient centricity in all of pharma. But Parexel did share some very compelling data on research it has conducted on the business case that supports patient-centric clinical trial designs. I’m itching to share the whole roundtable information, but I have to wait for the final article approvals. Also, the roundtable was conducted under our sister brand Pharmaceutical Executive, so you’ll be seeing that info come out under its branding. But suffice to say...the discussion was good, and the article will be great. Here are some highlights:
Patient-Centric Trials. Once the industry embraced the terminology of patient centricity in clinical trials, it’s been hard to shake the plans, the pilots, and the progress forward. But true ROI? Measurable results? That’s been a bit harder to quantify. Until now. Parexel shared data it had amassed, which include the following:
Patient-centric trials recruit twice as many participants (533) compared to non-innovative trials (271)-and in almost half the time.
Patient-centric trials in the U.S., the EU, China, and Japan took half the time to recruit 100 participants compared to other geographies (2.6 months vs 5.3 months).
Patient-centric trials in the selected geographies also recruited twice as many participants (819) compared to other geographies (377).
Patient-Centric Relationship to Product Launch. For clinical trialists, this statistic may not be why you want a patient-centric trial. You may want it because it’s good for recruitment, enrollment, diversity, and retention. But, at the end of the day, patient-centric trials help pay for drug development vis-à-vis a potential product launch. Drugs that include patient-centric designs were 19% more likely to be launched. And, in the real world, the product adoption rate was 13.7%.
To compare, three other innovations included adaptive design, precision medicine trials, and real-world data trials. Their likelihood of launch increased 13%, 10%, and 21%, respectively, while their adoption rate post-launch affected positively .6%, 5.2%, and .3%, respectively.
Patient Centricity: Not a Centric Force. There was considerable discussion around the table about that nature of patient-centric and patient engagement ownership within an organization, as well as the fragmented external forward movement within industry. That pharma tends to work in “pilot mode,” where a budget for an idea or implementation is very short term, and very focused. Once completed, there is no continuity. Another barrier is that the budget lies in different departments, without a centralized accountability, and patient engagement is often not a built-in, upfront approach to clinical trials, but instead becomes an add-on item.
Because of these very different internal challenges, external collaborations almost get lost in the discussion, but patient advocates are pushing every day to get their voices heard.