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Item COVID-19, Social Justice, and Clinical Cancer Research(Oxford University Press, 2020-10-15) Doroshow, James H.; Prindiville, Sheila; McCaskill-Stevens, Worta; Mooney, Margaret; Loehrer, Patrick J.; Medicine, School of MedicineThe COVID-19 pandemic and related socioeconomic events have markedly changed the environment in which cancer clinical trials are conducted. These events have resulted in a substantial, immediate-term decrease in accrual to both diagnostic and therapeutic cancer investigations as well as substantive alterations in patterns of oncologic care. The sponsors of clinical trials, including the United States National Cancer Institute, as well as the cancer centers and community oncology practices that conduct such studies, have all markedly adapted their models of care, usage of health care personnel, and regulatory requirements in the attempt to continue clinical cancer investigations while maintaining high levels of patient safety. In doing so, major changes in clinical trials practice have been embraced nationwide. There is a growing consensus that the regulatory and clinical research process alterations that have been adopted in response to the pandemic (such as the use of telemedicine visits to reduce patient travel requirements and the application of remote informed consent procedures) should be implemented long term. The COVID-19 outbreak has also refocused the oncologic clinical trials community on the need to bring clinical trials closer to patients by dramatically enhancing clinical trial access, especially for minority and underserved communities that have been disproportionately affected by the pandemic. In this Commentary, changes to the program of clinical trials supported by the National Cancer Institute that could improve clinical trial availability, effectiveness, and diversity are proposed.Item Data points on the growth of international human subjects research(http://bioethics.iu.edu/, 2011-02-23) Odell, Jere D.This fact sheet provides a referenced list of data points demonstrating the growth of internationalization in clinical research. In 2008, 78% of all subjects in U.S. funded clinical trials were enrolled in non-U.S. sites.Item In the COVID-19 era, let’s keep an eye on clinical trials in Africa(International Society of Global Health, 2020-07-28) Agoro, Rafiou; Medical and Molecular Genetics, School of MedicineDue to the high contagiousness of COVID-19 and the lack of an effective medicine, governments and companies are urging their teams to develop new vaccine and therapy with the noble mission to protect us from COVID-19 and preserve our economic achievements. However, under the current pandemic circumstances, we cannot exclude the possibilities that some scientists violate clinical trials rules and guidelines to accelerate new vaccine and medicine development. Low-income countries, notably Africans, could be preferred as a basis for experimentations on human subjects due to the lack of stringent policies in comparison to their high-income counterparts.Item OER Demonstration for Introduction to Clinical Trials(2020-11-20) Odell, Jere D.This is a demonstration of how an instructor could use Open Educational Resources (OERs) to create a college course for the subject: Clinical Trials. These four modules cover: 1. What are Clinical Trials? And Why?, 2. What is the Role of the FDA?, 3. Keeping Up With the Regulations, and 4, Clinical Trials and You. The course includes discussion forum questions and activities. To view the course, import in Canvas.Item The Pharmaceutical Industry and International Clinical Research: One Company’s Approach(2006-05-09T17:09:06Z) Clayman, MFifth lecture in a series: International Research Ethics, May 5, 2006.Item Underrepresentation in Cardiovascular Disease Clinical Trials(2023-07-28) Khan, Uzair; Raman, SubhaBackground: When it comes to inequalities in medicine, there are countless avenues through which barriers are placed that lead to worse health outcomes for marginalized groups. One inequality that isn't mentioned nearly as often is how difficult it is for marginalized groups to participate in clinical trials. As such, the results from these studies are most broadly applicable only to white men, the most common demographic to participate, as opposed to people from all races and backgrounds. The project for this summer is the first step in a longitudinal project meant to identify and address the barriers that preclude marginalized groups from participating. Methods: There are three steps to researching this underrepresentation. The first is a literature review. In this step, we searched for any existing literature about the presence of underrepresentation in cardiovascular disease (CVD) clinical trials as well as in other fields. From this literature, the results were analyzed, to ensure the validity of conducting our study, as well as the methodology of the studies, to ensure our own research will follow the established methods of other successful studies. The second is to interview experts in the field, such as others who research this topic as well as cardiologists and community leaders, to determine what barriers and solutions they believe decrease participation of POC patients. The final step is to conduct our own clinical trial that addresses those barriers by applying solutions discerned from the previous steps and creates a successful methodology to properly include underrepresented patients in the future. For this summer, we made it to the second step. Results: The literature review found that there indeed exists a discrepancy in participation of POC patients in clinical trials. Specifically, while the percent of overall nonwhite participation has increased, the number of black participants has remained the same since January of 2001, indicating that while there has been improvement in this inequality, there is still a need to improve recruitment for black participants specifically (Tahhan et al., 2020). Findings from the literature review also indicated potential barriers for underrepresented groups, including mistrust of clinical trials as a whole, time/resources constraints, and just a general lack of awareness of the existence of clinical trials (Clark et al., 2019). While determining solutions is part of the future directions of this study, Clark, et al. seems to suggest that the best solutions will address the interface between patients, physicians, and clinical trial teams on all 3 levels. One final conclusion from the literature review is the fact that there was “no price to pay for achieving diversity” (Batchelor et al., 2021). In looking at studies all over the country from 2 US National Coronary Stent Registries, a higher focus on increasing racial minority groups and women did not negatively influence research site performance, and possibly could lead to lower protocol deviation rates. While the interview portion of the study has yet to be completed, we have interviewed Francine Epperson, a researcher who has investigated barriers to black patient participation in Alzheimer’s clinical trials. Her study concluded that one facilitator to increase black participation is a “return of results to make informed decisions about their health” (Eliacin et al., 2023). Too often, clinical trials take results from participants and apply them elsewhere, with their participants being none the wiser as to what they helped accomplish. By applying and sharing the results of the studies to the communities that are recruited, we establish trust and a continued partnership, something that is desperately needed to help address the underrepresentation in cardiovascular disease clinical trials. Future Directions: The next steps in this project include conducting expert interviews, including cardiologists but also public health and community leaders, to determine barriers to participation and potential solutions. The final step involves consolidating the first two steps into solutions that can be used to conduct a clinical trial that minimizes barriers and increases rates of nonwhite participation. Citations: Batchelor, W. B., Damluji, A. A., Yong, C., Fiuzat, M., Barnett, S. D., Kandzari, D. E., Sherwood, M. W., Epps, K. C., Tehrani, B. N., Allocco, D. J., Meredith, I. T., Lindenfeld, J., O'Connor, C. M., & Mehran, R. (2021). Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J, 236, 37-48. https://doi.org/10.1016/j.ahj.2021.02.003 Clark, L. T., Watkins, L., Pina, I. L., Elmer, M., Akinboboye, O., Gorham, M., Jamerson, B., McCullough, C., Pierre, C., Polis, A. B., Puckrein, G., & Regnante, J. M. (2019). Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol, 44(5), 148-172. https://doi.org/10.1016/j.cpcardiol.2018.11.002 Eliacin, J., Polsinelli, A. J., Epperson, F., Gao, S., Van Heiden, S., Westmoreland, G., Richards, R., Richards, M., Campbell, C., Hendrie, H., Risacher, S. L., Saykin, A. J., & Wang, S. (2023). Barriers and facilitators to participating in Alzheimer's disease biomarker research in black and white older adults. Alzheimer's & Dementia: Translational Research & Clinical Interventions, 9(2). https://doi.org/10.1002/trc2.12399 Tahhan, A. S., Vaduganathan, M., Greene, S. J., Alrohaibani, A., Raad, M., Gafeer, M., Mehran, R., Fonarow, G. C., Douglas, P. S., Bhatt, D. L., & Butler, J. (2020). Enrollment of Older Patients, Women, and Racial/Ethnic Minority Groups in Contemporary Acute Coronary Syndrome Clinical Trials. JAMA Cardiology, 5(6), 714. https://doi.org/10.1001/jamacardio.2020.0359