In his recent Congressional budget briefing, NIH Director Dr. Francis S. Collins extolled the translational science of Dr. Stephen Aller, associate professor, UAB Dept. of Pharmacology and Toxicology, who has integrated a cutting-edge technology (cryo-electron microscopy, or cryo-EM) into his Cystic Fibrosis research on the misfolding of membrane proteins that contributes to the symptoms and shortened life expectancy of those with this disease.
“The goal is to turn CF into a 100% curable disease,” Collins said, “and for that we need the next-generation of scientific talent. Among the early stage investigators tackling this challenge is Stephen Aller, UAB. Trained in both computer science and biology, Stephen plans to fundamentally transform the way we deliver drugs for all kinds of conditions.”
Aller, who holds a PhD in Molecular Biophysics and Biochemistry from Yale, seeks to decipher the mechanism and function of integral membrane proteins in human disease and the means by which drug molecules and antibodies activate and inhibit function. He received a CCTS Drug Discovery Research Award in 2010, followed by an NIH Director’s New Innovator Award in 2011. His research holds great promise not only for producing new CF treatments, but also for reversing multi-drug resistance in cancer.
“The funding support provided by the CCTS allows scientists to take more risks, to think translationally when approaching complex diseases like CF and cancer. Cryo-EM technology could revolutionize research based on three-dimensional crystal structures of relevant mammalian membrane proteins.”
Collins showcased the work of three scientists from across the U.S. to underscore the critical importance of stable well-funded NIH budgets to enable scientific progress in diseases both common and rare. Aller was the first to be mentioned.
A video of Collins’ testimony is available at CSPAN.
The July CCTS Forum on “The Business of Clinical Trials: Who Pays? Who Profits?” drew a standing room only crowd despite a summer rainstorm that ended minutes before the presentation and panel discussion began.
Dr. Heather Hathorne, manager of the UAB Cystic Fibrosis Clinical Research Unit and the Child Health Research Satellite Unit (CHRU), kicked off the event with an overview of clinical trials: identifying all associated costs, developing a “fair and appropriate” budget, negotiating that budget with a sponsor, recovering costs throughout a trial’s lifecycle, and avoiding common pitfalls that can put a clinical trial in the red.
Capturing the costs of doing business
“The first thing you must know are your costs—indirects, patient care, personnel time (which has lots of hidden cost due to patient demands on the research team), study start-up, ‘invoiceable’ items, and study close out,” Hathorne said. Start-up fees, such as administering feasibility questionnaires, preparing for IRB review, preparing budgets and contracts, staff training, source document development, and site fees, fail to sometimes make it into a contract.
She also urged attendees to remember that “lack of enrollment does not equate to no cost—even studies that fail to enroll a single patient can incur significant start-up expenses.” She noted that her CF program start-up fees were approximate $19,000, “which we included on our letterhead as part of our trial fee schedule to be transparent with the sponsor prior to the start of negotiations.”
“Know your invoiceables!”
Hathorne advised budgeting for procedures that might happen as well those that would happen: screen fails, pregnancy tests, unscheduled visits, travel, overnight stays, IND safety reports, FDA audits. “It is important to account for these just in case,” she said, “because a CRO or sponsor will never offer you the amount of compensation you deserve, only the amount you negotiate.”
Time is money
Another area in which trials under budget is personnel time. Hourly rates are frequently underestimated, she said, because of fear a sponsor will walk away. But study visits can be complex and every visit should include billable PI time because they will have to review all notes even if they do not perform the physical exams. She encouraged using the Schedule of Events to identify the length of each visit, billable tests, whether there are both tech and professional costs associated with each test, the number of draws for a test, whether the lab used is central or local, and all personnel time involved. She urged a review of all footnotes for “hidden costs.”
Negotiation 101
Only when you have all of this data pulled together are you ready to negotiate, a process that should follow the same steps for every study:
- Know how far you can lower your charges without losing money
- Understand the concept of “fair market value”
- Establish a site-specific checklist
- Know when to walk away
Invoicing 101
“You negotiated the contract, you did the work, so COLLECT THE MONEY!” Hathorne said the average percentage of the budget that research sites do not collect is 26%. “Until OnCore is online, develop a system to help you track all charges and events, then submit invoices for all these items according to the time schedule outlined in your contract, and do not close your grant until you have received all payments” she advised. CCTS Director Dr. Robert Kimberly added that a new Yale study reported over 50% of “fair and appropriate” trial costs are not captured in budgets. By combining the two figures, "a trial stands to nearly double its income if the financial piece is done well," he noted.
Hathorne was joined by a panel of clinical trial experts, including Dr. Mansoor Saleh, Medical Director, UAB Clinical Trials Administration Office, and Director, CCTS/CCC Phase I Clinical Trial Unit; Dr. Steve Rowe, Director, Gregory Fleming James Cystic Fibrosis Research Center, and Co-Director, CCTS Child Health Research Unit; and Dr. Mark Dransfield, Professor, Division of Pulmonary, Allergy, and Critical Care, UAB Department of Medicine. All agreed that many investigators, especially those just starting out, “undervalue their studies and accept sponsor bids that are too low.”
Dr. Kimberly thanked the speakers and noted that improving the business side of clinical trials is ultimately about doing more for patients in a trial. He urged the conversation continue “as we prepare for the rollout of OnCore.” OnCore is an enterprise research system for clinical trial management.
In case you missed it, you can watch the July Forum video on our CCTS YouTube channel.
CEI hosted its 3rd Annual Conference on October 14, 2016, in Birmingham, AL. The theme was "The Journey to Justice: Expanding the Possibilities" (#CEI2016). Please see our recap of the event, including results from our CEI evaluation form.
For additional CEI highlights see the CCTS Digest article, "3rd Annual CEI Engages Stakeholders from across the Region and Beyond."
You can watch Kevin Powell's powerful presentation and Rep. Jeramey Anderson's stirring exploration of justice on our CCTS YouTube channel.
Slides from some of our outstanding breakout sessions are also available:
- Ending the Fights and Failures for Community Health
- Greenhouse of Hope: Cultivating Youth for Social Justice at Rust College
- Urban Blight: The Modern Miasma
For more information about our sessions, check out our 2016 Final Agenda.
For more information or questions concerning CEI 2016, or our 4th Annual CEI to be held Fall 2017, contact Shauntice Allen, PhD, at
CEI 2016 Photo Highlights
The CCTS One Great Community (OGC) board hosted a special reception to honor its six 2017 Community Health Innovation Award (CHIA) grantees. A total of $85,000 was distributed to enable these grantees to advance projects that address health concerns in the Birmingham community. The CCTS partnered with several units across the Hub to support this unique program.
All grantees participated in a rigorous application process that included attending a mandatory Innovation Workshop to refine their project ideas, submission of a full proposal that was formally reviewed against the CHIA criteria, access to mentorship, and a final presentation of their project before a panel of four judges.
CHIA is envisioned as a way for participants to think boldly and creatively about solutions to “on the ground” health challenges communities face, to work in partnership with some of the best minds in our area, and to partner with local organizations to complete a project. A list of community health concerns, based on the results of an OGC neighborhood survey, guided the selection process for the projects below.
2017 CHIA GRANTEE PROJECT DESCRIPTIONS
- Project Possible, Inc. – Provides nutrition education, healthy food samples, and cooking demonstrations to residents in Southwest Birmingham community. Academic collaborators through the UAB School of Public Health and Department of Nutrition Science will provide a minimum of two interns a semester to support data collection, evaluation development and analysis, and other program development efforts. This project addresses community concern about obesity/overweight.
- At Home Foundation, Inc. – Focused on single parents and low-income women learning life skills such as basic home repair. Will help build mental and emotional strength, self-confidence, self-sufficiency, and independence, all of which are foundational for good health.
- Westminster Presbyterian Church – Provides a free multi-arts program for elementary school children with emphasis on voice, speech, and acting. The program will be conducted by renowned playwright, Broadway, film, and television actor, composer/arranger, music instructor, and Westminster’s Director of Music Ms. Annie Joe Edwards. The Westminster Community Arts Program will meet all the standards for youth programs as required by the State of Alabama. Cultural activities build literacy and math skills and support the development of critical thinking and problem solving. This project addresses community concerns with reducing high school dropout rates and improving health literacy.
- Growing Kings, Inc. – Develops positive relationships between youth (aged 15-24) and law enforcement in housing communities across Birmingham. Seeks to achieve the following: (1) Improve youth’s general attitudes toward police as well as their feelings about their community; (2) Improve police officers’ general attitude toward youth as well as their perceived impact on youth through their police role; (3) Reduce the number of violent occurrences within the target participant demographic for each participating housing community; (4) Decrease the number of reported youth arrests in each housing community, and; (5) Improve participant behavior and decision making. This project addresses community concerns with crime, a social determinant of health with far-reaching negative mental and physical health effects.
- Community Investment Network – Project focused on a community-building plan that emphasizes philanthropy by exposing students to “giving circles” as innovative way to address issues in and around their school’s campus. Project will support the launch and strengthening of Giving Circles as a way of redefining and reframing philanthropy so that it is more racially inclusive, democratic, and accessible to people of all classes. Students from Lawson State Community College, Jefferson State, Community College, Miles College, Birmingham-Southern College, and the University of Alabama at Birmingham are eligible to participate. This project will help raise awareness of all community health concerns and increase the volunteer base available to help address them.
- Real Life Poets – An apprenticeship program focused on using spoken word and the arts to address mental health, workforce empowerment, and community involvement. Real Life Poets (RLP) creates a results-driven and empowering job-training and mentoring community hub for teen apprentices in the Eastlake Neighborhood of Birmingham. Cultural activities have been shown effective in lowering high school dropout and teen pregnancy rates, addressing two key community health concerns.
What does it take to move an NIH R01 grant through submission and resubmission to finally achieve the coveted “NOGA” (Notice of Grant Award)? More than 60 attendees gathered at our annual Mock NIH Study Section Review last week to find out. A real-world R01 grant that initially received a non-fundable impact score of 42, which improved to a fundable score of 25 after the investigator worked with CCTS, served as the focus of the review.
As defined by the NIH, “the Research Project Grant (R01) is an award made to support a discrete, specified, circumscribed project to be performed by the named investigator in an area representing the investigator’s specific interest and competencies, based on the mission of the NIH.”
CCTS Training Academy Director Dr. David Chaplin provided an overview of an NIH study section’s goals and processes and alternated between serving as study section chair and the Scientific Review Officer (SRO) (he wore a green visor to indicate when he was “in role” as SRO). The other panelists, including Dr. Karen Cropsey, associate professor, psychiatry and behavioral neurobiology, Dr. Jennifer Polluck, professor, medicine/nephrology, and Dr. Shannon Bailey, professor, molecular and cellular pathology, took turns acting as primary and secondary reviewers.
Attendees learned about the different sections of an R01 grant and how they are scored for scientific and technical merit. Panelists explained their mock scores regarding the overall impact grant and its strengths and weaknesses for review criteria, including significance, investigators, innovation, approach, and environment. They also discussed important considerations for human subject protections; inclusion of women, minorities, and children; animal welfare and biohazards (if applicable); resource sharing plans; and budget. The panelists also described the need to address NIH’s rigor, reproducibility, and transparency requirements, which apply to nearly all NIH grant applications, not just the R series.
Panelists stepped out of their roles to address several areas that can weaken an R01 grant: whether the number of subjects chosen is high enough to produce meaningful results and support a well-conceived power calculation; not providing a clear description of appropriate statistical analyses that will be performed; and failing to thoroughly address human subjects protection. Dr. Chaplin encouraged attendees to reach out to the CCTS for help in appropriately addressing these areas, noting R01 applicants who do so "greatly strengthen their grants and increase their chance of funding as much as three times the NIH baseline."
CCTS is grateful to its cohosts, the UAB Minority Health and Health Disparities Research Center and UAB Center for Outcomes and Effectiveness Research and Education. We also wish to thank our panelists and Dr. Adam Wende, assistant professor, UAB Dept. of Pathology, whose R01 grant, "Glucose-Mediated Remodeling of Cardiac DNA Methylation," served as the before and after model in the mock review. Dr. Wende is a 2016 CCTS Pilot awardee. For those who missed this event, a video is available on the CCTS YouTube channel.
The Mock NIH Study Section Review traditionally marks the end of our Clinical and Translational Science Training Program (CTSTP). From Jan. to June, our 2017 CTSTP trainees received more than 50 hours of didactic instruction in research project development, ethics, clinical trials, epidemiology, biostatistics. They gained exposure to many types of clinical and translational research, including health services, genomics/informatics, behavioral, and community-based participatory research. The Mock NIH Study Section Review is a highlight for many trainees, especially those who plan to pursue a career in research.
Interested in becoming a CTSTP trainee? Email your interest and/or questions to