Technology is transforming how clinical trials are run. A panel during MedCity News’ INVEST Digital Health conference discussed the tech trends shaping the design and execution of drug studies.
As the industry focuses on creating a more holistic, inclusive experience, these three focus areas can help bridge the gap between patient, site, and clinical research administrators and help to modernize the clinical trial experience for all.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
he FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs. Even so, the Agency is starting to acknowledge – and thereby support – the global shift towards expanded trial models. Essentially, the FDA is implicitly broadening the definition of clinical trials.
CVS Health is winding down its clinical trials business, with a full exit expected by December 31, 2024, the company confirmed to MedCity News. But decentralized clinical trials still have an important role to play, said Brian Weiss, CEO of Carebox.
With the FDA’s acceptance and encouragement of decentralized trials, we can expect to see a continued shift towards remote trial conduct, virtual sites, and the use of innovative digital technologies.
The agency’s goal is to spur a macro shift in clinical trials. The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Historically, clinical trials have not prioritized the experiences of patients, who are required to frequently return on-site and engage with unfamiliar medical technology. They are often left in the dark regarding the data and health outcomes being collected through their participation.
Clinical research as a care option is a means of connecting patients with clinical research as part of their ongoing health care, located where they receive that care, and offered by their trusted provider.
Added complexity to daily life is likely why patient dropout rates remain high, with 19% leaving studies before completion. Truly patient-centric trials will allow for broader participation, allowing patients to decide how and when they want to engage in a study.
Two decentralized clinical trial methodologies that are “low-hanging fruit” include automating data integration for patient trial selection and establishing standardized, electronic clinical trial templates and procedures.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
When patients can travel to a pharmacy or doctor’s office in their own neighborhood, they can reach the site on foot or using public transit. They also have to take less time off work and request childcare less often.
Medable recently launched a software solution to shorten the launch times for decentralized vaccine trials. The company says the software can reduce trial deployment timelines from more than 12 weeks on average to as short as five weeks.
Decentralized clinical trial approaches helped the pharma industry navigate through Covid-19. Now it is becoming increasingly clear that there’s a need for a hybrid approach to decentralized clinical trials that considers the perspectives of patients and the impact to clinical trial sites.
A recent webinar by Medable discussed steps it's taking to improve clinical trial design through decentralized clinical trials
The Pitch Perfect contest at MedCity INVEST PharmaTech, the free virtual conference scheduled for July 26, will spotlight five startups seeking to improve clinical trials.