Poets&Quants | BIG IdeaBounce 2024 | 14 Finalists Dazzle In SharkTank Contest

Team CORE (COnnecting REsearch)

School Affiliation: Michigan Ross

Description: CORE is an innovative tool that democratizes clinical trials by promoting diversity, equity, inclusivity by using machine learning technologies to connect and match the participant with the clinical trial sponsor and vice versa, thus creating a win-win for both researchers and participants by allowing studies to recruit and retain traditionally underrepresented populations while giving these groups more opportunity to enroll in lifesaving and boundary-pushing medical research.

Problem:

Insufficient demographic diversity in clinical trials has long been recognized as an issue that may hinder innovation and access to therapies. There are currently a total of 471,052 registered clinical studies according to clinicaltrials.gov. Clinical trials in the U.S. have long skewed toward recruiting mostly white males and among 32,000 individuals who participated in new drug trials in the U. S. in 2020, only 8% were Black, 6% Asian, 11% Hispanic, and 30% were age 65 and older, showing relative underrepresentation of these important demographic groups. These estimates have worsened since 2019 and are not aligned with U.S. Census data, which found 14.2% of the population was Black, 7.2% Asian, and 18.7% Hispanic.

In contrast to these low trial participation statistics, underrepresented racial and ethnic minority groups carry a disproportionately high burden of chronic diseases that garner the most investment in drug research and development. In addition to being underrepresented as participants in clinical trials, racial and ethnic minority groups are underrepresented among investigators in clinical research. Among 600,000 full-time faculty at academic institutions, less than 5% are African American, 3% Hispanic, and 1% Native American.

Our research into CORE’s market has revealed that $708 billion spent is spent in U.S. research and development, and clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health. The median cost of conducting a study from protocol approval to final clinical trial report was US$3.4 million for phase I trials involving patients, $8.6 million for phase II trials and $21.4 million for phase III trials. Each additional month for phase III trials translates into a median $671,000 spent. With this as a baseline, even small cycle-time reductions could have meaningful benefits on overall clinical development budgets. A 10% decrease in costs leads to 20,000 additional studies or approximately 380 million dollars in savings.

In their guidance for industry, the FDA identified the use of digital health technology tools as a key strategy to enhance diversity in clinical trials. CORE can help improve access and decrease participant burden, thus enhancing participant experience and increasing diversity in clinical trials. It can also reduce the cost and improve recruitment and retention from a sponsor perspective resulting in more robust outcomes.

Solution:

CORE is an innovative accessible, user-friendly software platform that democratizes clinical trials by using machine learning technologies to connect and match the participant with the clinical trial sponsor and vice versa.
Outside of simple matchmaking, CORE also includes basic avenues for users to express interest for studies; the system will evaluate if the potential participant meets the criteria to join the study and provide an option to join a database of interested users and attain access to contact information.

While currently, as a standalone digital health product, CORE is uniquely positioned to tackle the unmet recruitment and retention challenges that face modern clinical trials, especially when it comes to DEI and it fits securely in the participants recruitment and retention portions of the clinical study workflow. After researchers set up their studies, CORE supports them in finding the best participants possible, while at the same assisting anyone in finding clinical trials that match their qualifications, interests, and demographics.

Market:

Our research into CORE’s market has revealed that $708 billion spent is spent in U.S. research and development, and clinical trials that support FDA approvals of new drugs have a median cost of $19 million per study, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health with 10% YOY growth rate. The median cost of conducting a study from protocol approval to final clinical trial report was US$3.4 million for phase I trials involving patients, $8.6 million for phase II trials and $21.4 million for phase III trials. Each additional month for phase III trials translates into a median $671,000 spent. With this as a baseline, even small cycle-time reductions could have meaningful benefits on overall clinical development budgets. A 10% decrease in costs leads to 20,000 additional studies or approximately 380 million dollars in savings.

Competition:

There are a number of competitors in the digital research/clinical trial management space but CORE’s principal edge and value proposition over the other competitors is in improving access, DEI focus and bi-directional matchmaking by creating an accessible interface on both the researcher and participant sides which enables us to facilitate recruitment more efficiently than Ripple Science, EZ Access, or Medable. Our strength in this area combined with our focus on recruitment, retention and stability in other comparison categories helps us stand out in the ever-changing digital research landscape.

Value Creation:

The Team:

Karthik Ramani, MD, MBA’24; Ethan Marshall, CSE’25; Amit Dongaonkar, BE,MBA’24