The evolution of clinical trials shows that although much has changed, several things remain the same. When a patient expresses interest in a trial, they complete an informed consent process, and complete a series of structured visits to provide data used to assess the safety and efficacy of a product. Although a 30 year veteran of clinical research would have little problem interpreting and understanding a modern clinical trial protocol, digital tech has transformed other aspects of clinical trials. Data gathering is paperless. The intersection of digitized healthcare data with AI applications, such as machine learning and predictive analytics, to assess and analyze clinical trial data has created innovative ways to identify and recruit clinical trial candidates, support remote patient monitoring and decentralized clinical trials. In response to emailed questions, Noah Goodson, Clinical Trial Design Director with THREAD, a CRO, highlighted some of the milestones in clinical trial design, including patient-centered clinical trials.
It wasn’t until 1993 that Congress mandated that women be included in NIH funded clinical trials, Goodson noted. He acknowledged that although trials tend to be more diverse than they used to be, many historically marginalized groups remain underrepresented. The bigger picture is to ensure that more patients have access to drugs that are effective.
“It was just April 2022 when the FDA put out the first draft guidance indicating that having a Race and Ethnicity Diversity Plan would be a future requirement,” Goodson noted. “This doesn’t mean this is the first time that there is a push for diversity in clinical research, but we are only now getting to the place where regulators are going to say that this is a requirement.”
At MedCity INVEST Digital Health, clinical trial design will be just one of the topics discussed at the conference. To learn more and register for the conference in collaboration with HEALTH WILDCATTERS October 26 in dallas, CLICK HERE.
With the digitization of data, clinical trials have also become increasingly complex to execute. Goodson references some impressive stats to convey how much trials have evolved. In the 10 years from 2005-2015, he noted that the number of distinct procedures within trials increased by as much as 59%. In that same time period, the number of total procedures completed went up by 70%, and the administrative burden increased 82%. Goodson added that it’s not surprising that the costs of clinical trials have also increased by 50% in that same time period.
“We want to measure what matters medically, but we also really want to measure what matters to the patients themselves,” said Goodson. “If they say ‘Hey, before I couldn’t get up and make breakfast for myself, but now I can!’ that is a really powerful change that makes their lives better. We want to make sure the tools we are deploying in research are able to capture that data and reflect it, along with other objective evidence, in how we evaluate the safety and efficacy of a therapy.”
Patient-centered clinical trials are a particularly hot topic of discussion since tech has evolved to a point where decentralized clinical trials are possible, though they can be complex to execute.
One of the challenges Goodson said THREAD is working to overcome is that it’s not possible to be truly patient-centric without taking into account the needs of other “users” within a clinical trial ecosystem. Goodson explained that THREAD has based some aspects of its approach on principles from Human-Centered Design (HCD) developed by design theorist Don Norman:
- Be people centered
- Understand and solve the right problem
- Everything is a system
- Use small, simple interventions.
To be people-centered, you need to consider every user. That means technology has to work for clinical researchers, principal investigators, data managers, and the participants, according to Goodson.
“There are definitely times when a solution that looks like it will help the participant actually makes a lot of big challenges for research sites – if you don’t consider the implications for those users, it’s pretty easy to accidentally make things less-patient centric because they cannot be practically implemented at scale. To get to solutions, you’ve got to understand the systems the various users engage with, solve the right problem and (my favorite) — find small simple interventions. While this is just one design theory, we’ve seen some great outputs in how we operationalize for customers by taking this approach and we hope to see more in the industry apply similar thinking to bring speed, efficiency, and patient-centricity to trial design and deployment.”
Providing ways for patients to provide input throughout the design process is critical, Goodson observed. It’s important to understand the patient’s lived experience, make sure the clinical trials collect relevant data, and ensure that studies are deployed in such a way that they work for patients’ daily lives.
Clinical trial design will be one of the topics discussed at the INVEST Digital Health conference with Health Wildcatters at Pegasus Park in Dallas on October 26. To check out the agenda and register, click here.
Photo: bluebay2014, Getty Images
