Clinical Researcher—November 2021 (Volume 35, Issue 8)

OVER THE TRANSOM

Gary W. Cramer

In addition to education, an integral part of any academic medical center’s mission is its research agenda. While recognizing the value of teaching, academics requires asking questions. It is vital to understand the mechanisms of health and illness, how to treat patients and their diseases more effectively, and how to provide healthcare to a community more effectively.

The sentiments above come from the introduction to a 2000 article in The Ochsner Journal on “The Roles of Research in an Academic Medical Center.” The author goes on to indicate that the “end product of clinical research is the knowledge that allows us to understand disease processes and the prevention and treatment of these diseases. Clinical research is vital to achieving our ultimate goal of promoting health.” He also notes how the Association of American Medical Colleges had “emphasized the need for teaching hospitals and medical schools to reaffirm that clinical research is part of their fundamental mission.”

It’s obvious that many institutions have taken this message to heart. For example, a webpage on “What it Means to be an Academic Medical Center” from the University of Pennsylvania’s Penn Medicine notes that, “With physicians, nurses, researchers, and teachers all working in unison, patients have better access to the latest medical breakthroughs and clinical trials that aren’t available at other hospitals.” Further, one can point to how nearly 20% of ACRP members report themselves as working in academic/university settings to highlight the importance of this segment of the clinical research enterprise in the scheme of research and development for drugs, devices, diagnostics, surgical techniques, and other forms of therapy.

With all of this in mind, this column delivers recent news from a variety of academic medical centers that are sticking to the agenda of clinical research activities vital to the advancement of scientific understanding for healthcare improvements and breakthroughs (no endorsements implied).

$31.7 Million Award Aims to Harmonize Alzheimer’s Research Data

Vanderbilt University Medical Center has been awarded a five-year, $31.7 million grant by the National Institute on Aging, part of the National Institutes of Health (NIH), to harmonize research data gathered on human subjects in scores of disparate studies of Alzheimer’s disease and related dementias (ADRD).

ADRD is studied from various angles, and from one human research cohort to the next the data are collected in different ways and at different scales, with many datapoints conforming to ad hoc definitions. Starting with data from more than 30 research cohorts, the new project will pool these data using data harmonization principles that are well established. This will produce a large-scale, racially diverse, standardized set of transparently defined data that will support machine learning and open new windows into the genetic basis of ADRD and Alzheimer’s resiliency. The goal: stimulation of new drug development.

Research data types encompassed by the project range from clinical information to genomics, cognitive performance, neuroimaging, biomarker data (currently derived from cerebrospinal fluid analysis), and autopsy neuropathology data. Per NIH data-sharing policies, the harmonized data will be available to qualified researchers from far and wide, primarily via established, secure computing resources supported by the National Institute on Aging.

$25 Million Award Seeks to Enhance Medical Research, Human Health

Expanded partnerships, access to clinical trials, and new medical and behavioral treatments and interventions reaching individuals more quickly will benefit communities in Pennsylvania and beyond thanks to the renewal of Penn State’s Clinical and Translational Science Award (CTSA) funded by the NIH. The NIH’s National Center for Advancing Translational Sciences awarded Penn State more than $25 million to provide critical clinical and translational research infrastructure and continue building collaborations across the university’s campuses and with communities around the state.

The CTSA Program develops innovative solutions to improve processes for turning laboratory, clinical, and community research into health knowledge, interventions, and treatments. CTSA institutions partner to advance biomedical and health research and share best practices and tools. Penn State is one of 64 funded CTSA organizations nationally and is among the few that serve primarily rural communities.

The institute’s involvement in the CTSA Program Trial Innovation Network gives Pennsylvania residents opportunities to become involved in both large national, and smaller local, clinical trials. It has supported several trials involving diagnostics and treatments, including for COVID-19, at Penn State Health Milton S. Hershey Medical Center through its Clinical Research Center. Clinical Research Centers, located at both the Hershey and University Park campuses, provide dedicated space and research staff for study visits. Studyfinder is the university’s searchable website of actively recruiting research studies.

$5 Million Award Goes to Training of Diverse Researchers

The University of California, Irvine (UCI) has received a five-year, $5 million award from the California Institute for Regenerative Medicine (CIRM) to support a comprehensive doctoral, postdoctoral, and clinical researcher training program to prepare the current and next generation of leaders in stem cell biology, gene therapy, and regenerative medicine.

With an emphasis on basic and translational research, the award will support 12 fellows and be administered through the Sue & Bill Gross Stem Cell Research Center. This funding will expand and extend the successful track record of the center’s previous CIRM grants, which enabled the training of 73 scientists in 40 labs at UCI between 2005 and 2015.

A major goal of the CIRM training program is to increase diversity in stem cell research and help shape California’s regenerative medicine workforce into one more representative of the state’s population. Federally designated as an Asian American and Native American Pacific Islander-Serving Institution and a Hispanic-Serving Institution, UCI facilitates the recruitment of a diverse cohort.

Medical Center and Foundation Collaborate on Treatments for Rare Cancers

The University of Texas MD Anderson Cancer Center and the Rare Cancer Research Foundation have announced the launch of a collaboration designed to accelerate the development of new treatments for rare cancers by empowering all patients in the United States to contribute tumor samples directly to MD Anderson for translational research efforts.

This initiative is designed to overcome a major obstacle that has long prevented significant progress in rare cancer research—the lack of available samples. The Rare Cancer Research Foundation will use its Pattern.org online engagement platform to enable patients to donate tumor biopsies and surgical samples for research purposes.

With these samples, MD Anderson researchers will perform comprehensive analyses and will work to develop laboratory models that can be used to pursue new therapeutic strategies for rare cancers. New discoveries then can be used to design and launch clinical trials to evaluate these strategies for patients in need.

Rare cancers are defined as those with fewer than 40,000 new cases diagnosed annually in the U.S. Taken together, rare cancers represent roughly 25% of all cancer cases and are the leading cause of cancer-related deaths. The initiative aims to fully characterize more than 60 rare cancer samples and develop 20 laboratory models. These data and models will be made available to the research community, allowing scientists worldwide to contribute breakthroughs to the field.