Science technology research library.
Health technology startup HumanFirst is changing the way clinical trials are run by putting people at the center of drug development. The company already works with many leading pharmaceutical companies and CROs through their AtlasPro offering–the industry’s most comprehensive library of digital measures and technology–and has just released a new platform called AtlasEDU designed to give qualified academic researchers access to their comprehensive library, free of charge.
Dr. Jessilyn Dunn, Professor of Biomedical Engineering at Duke University, says “no tool like the Atlas exists.” She has been using the new platform and says it lowers barriers to entry and ”makes the process of finding evidence and specific literature surrounding a specific digital health tool or topic extremely accessible.”
HumanFirst founders say the key is putting the human at the center of drug development, and recently launched the industry’s first comprehensive and open-access ontology of digital measures and endpoints. Their vision is that such measures are well positioned to augment our understanding of disease processes with better population subtyping and individual phenotyping.
Dr. Manny Fanarjian, Head of Applied Sciences said, “we’ve spent the past several months advancing our algorithms and curation processes so we could support academic investigators driving critical research advancements.” They call it specifically ‘human-first’ rather than ‘patient-first’ because if done right, fewer people become patients as the focus of health shifts toward prevention.
HumanFirst is already working with 22 of the top 25 pharmaceutical companies to enable better integration and analysis of digital health technologies (DHTs) in clinical trials. The company started in 2019 and offers workflow and infrastructure solutions to support hybrid and at-home clinical trials and research. In addition to top pharmaceutical companies, they work with leading research universities to prepare for, execute and analyze deployment of DHTs.
Health tech entrepreneur Andrea (Andy) Coravos, is a leader in digital health and decentralized clinical trials and a research collaborator at the Harvard-MIT Center for Regulatory Sciences. Her work to modernize clinical research has previously been profiled in Forbes. She collaborated to build HumanFirst with Dr. Fanarjian, an engineer and physician with an interest in the evolving role of healthcare technology in the delivery of medicine.
The drug development industry is moving to embrace new technology. According to experts, “a record number of around 1,300 trials” will launch with a hybrid/decentralized element in 2022. However, researchers need better tools to sort though the tremendous amount of technology choices to determine what has been previously used and considered reliable for human study.
Digital cardiology markers
Creating norms using digital biomarkers and outcomes is critical. Industry luminary Dr. Amy Abernethy and FDA Commissioner Rob Califf have previously pointed out how the industry needs improve, and describe the needs for a “learning health system” that is based on incorporating data from personal technology such as smartphones and watches, understanding treatment impact on outcomes, and being able to identify improvements in care. The belief is that product development should leverage available technology.
AtlasEDU is a free version of HumanFirst’s platform designed specifically for qualified academic researchers. It will help accelerate clinical study design and implementation. The platform has been used by Sandya Subramanian, a data science fellow at Stanford University who said it has helped her research by “seeing technology or measures that I didn't think were possible.” It makes surveying available equipment, obtaining and testing it, and comparing the pros and cons of different technologies for an upcoming study a painless process. Subramanian says, “it really helps build credibility for digital health and wearables because each piece of technology included is well-documented in terms of both technical specs and use in research studies.”
Duke’s Dr. Dunn says the platform “will improve the public’s trust in digital health products.” Additionally it will help researchers avoid wasting time “wrangling current literature around a particular topic.”
The HumanFirst platform is the most comprehensive database of measures and technologies and offers a workflow tool to support the selection process. It provides experts with 11,000+ physiological and behavioral digital measures captured by 2,000+ connected sensors in 6,500+ pieces of evidence (peer-reviewed papers, clinical trials, FDA decisions, etc.) across 800+ medical conditions.
The unique comprehensive platform will make clinical research design significantly more efficient. “There's nothing else similar available,” Subramanian says. “Prior to the HumanFirst platform, clinical study researchers would need to invest considerable efforts on internet searches for appropriate technology or devices.”
Innovation in clinical research is desperately needed. It can cost billions of dollars to bring a successful drug to market–when also accounting for the costs of unsuccessful drugs–and it takes an average of 10 years for a new medicine to complete the journey from discovery to marketplace. The use of digital tools can provide early intelligence to sponsors to either accelerate promising drugs coming to market, or discontinue work on unpromising drugs sooner, saving money and resources.
Challenges extend beyond prohibitive costs. More than 80% of clinical trials fail to recruit enough patients on schedule, and there are systemic barriers that block health equity and access. Notably, Black Americans make up 14% of the U.S. population but only 8% of clinical trial participants; for Hispanic or Latino Americans, those numbers are 19% and 11%, respectively. Digital measures and biomarkers have the opportunity to drive more inclusivity and better evidence for clinical investigations.
Interested researchers can apply directly with this 5-minute grant application form to see if they qualify for AtlasEDU access.
