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Full-Text Articles in Medicine and Health Sciences
The Costs Of Developing Treatments For Alzheimer’S Disease: A Retrospective Exploration, Jeffrey L. Cummings, Dana P. Goldman, Nicholas R. Simmons-Stern, Eric Ponton
The Costs Of Developing Treatments For Alzheimer’S Disease: A Retrospective Exploration, Jeffrey L. Cummings, Dana P. Goldman, Nicholas R. Simmons-Stern, Eric Ponton
School of Medicine Faculty Publications
Introduction: With the exception of the recent accelerated approval of aducanumab, in over 26 years of research and development (R&D) investment in Alzheimer's disease (AD), only five novel drugs—all for symptomatic treatment only—have reached FDA approval. Here, we estimate the costs of AD drug development during this period in the private sector. Methods: To estimate private R&D funding, we collected information on AD clinical trials (n = 1099; phases 1–4) conducted between January 1, 1995 and June 21, 2021 from various databases. Costs were derived using previously published methodologies and adjusted for inflation. Results: Since 1995, cumulative private expenditures on …
Alzheimer's Disease Drug Development Pipeline: 2019, Jeffrey Cummings, Garam Lee, Aaron Ritter, Marwan Sabbagh, Kate Zhong
Alzheimer's Disease Drug Development Pipeline: 2019, Jeffrey Cummings, Garam Lee, Aaron Ritter, Marwan Sabbagh, Kate Zhong
School of Medicine Faculty Publications
Introduction Alzheimer's disease (AD) has few available treatments, and there is a high rate of failure in AD drug development programs. Study of the AD drug development pipeline can provide insight into the evolution of drug development and how best to optimize development practices. Methods We reviewed clinicaltrials.gov and identified all pharmacologic AD trials of all agents currently being developed for treatment of AD. Results There are 132 agents in clinical trials for the treatment of AD. Twenty-eight agents are in 42 phase 3 trials; 74 agents are in 83 phase 2 trials; and 30 agents are in 31 phase …
Two-Stage Optimal Designs With Survival Endpoint When The Follow-Up Time Is Restricted, Guogen Shan, Hua Zhang
Two-Stage Optimal Designs With Survival Endpoint When The Follow-Up Time Is Restricted, Guogen Shan, Hua Zhang
Public Health Faculty Publications
Background: Survival endpoint is frequently used in early phase clinical trials as the primary endpoint to assess the activity of a new treatment. Existing two-stage optimal designs with survival endpoint either over estimate the sample size or compute power outside the alternative hypothesis space. Methods: We propose a new single-arm two-stage optimal design with survival endpoint by using the one-sample log rank test based on exact variance estimates. This proposed design with survival endpoint is analogous to Simon’s two-stage design with binary endpoint, having restricted follow-up. Results: We compare the proposed design with the existing two-stage designs, including the two-stage …
The Price Of Progress: Funding And Financing Alzheimer's Disease Drug Development, Jeffrey Cummings, Carl Reiber, Parvesh Kumar
The Price Of Progress: Funding And Financing Alzheimer's Disease Drug Development, Jeffrey Cummings, Carl Reiber, Parvesh Kumar
School of Medicine Faculty Publications
Introduction Advancing research and treatment for Alzheimer's disease (AD) and the search for effective treatments depend on a complex financial ecosystem involving federal, state, industry, advocacy, venture capital, and philanthropy funding approaches. Methods We conducted an expert review of the literature pertaining to funding and financing of translational research and drug development for AD. Results The federal government is the largest public funder of research in AD. The National Institute on Aging, National Institute of Mental Health, National Institute of General Medical Sciences, and National Center for Advancing Translational Science all fund aspects of research in AD drug development. Non-National …
Statistical Advances In Clinical Trials And Clinical Research, Guogen Shan, Sarah Banks, Justin B. Miller, Aaron Ritter, Charles Bernick, Joseph Lombardo, Jeffrey L. Cummings
Statistical Advances In Clinical Trials And Clinical Research, Guogen Shan, Sarah Banks, Justin B. Miller, Aaron Ritter, Charles Bernick, Joseph Lombardo, Jeffrey L. Cummings
Public Health Faculty Publications
Introduction New treatments for neurodegenerative disease are urgently needed, and clinical trial methods are an essential component of new drug development. Although a parallel-group study design for neurological disorder clinical trials is commonly used to test the effectiveness of a new treatment as compared to placebo, it does not efficiently use information from the on-going study to increase the success rate of a trial or to stop a trial earlier when the new treatment is indeed ineffective. Methods We review some recent advances in designs for clinical trials, including futility designs and adaptive designs. Results Futility designs and noninferiority designs …
The Role Of Functional, Social, And Mobility Dynamics In Facilitating Older African Americans Participation In Clinical Research, Eve T. Shapiro, Jay T. Schamel, Kimberly A. Parker, Laura A. Randall, Paula M. Frew
The Role Of Functional, Social, And Mobility Dynamics In Facilitating Older African Americans Participation In Clinical Research, Eve T. Shapiro, Jay T. Schamel, Kimberly A. Parker, Laura A. Randall, Paula M. Frew
Environmental & Occupational Health Faculty Publications
Purpose: Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans. Methods: Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation.
Results Of A Community Randomized Study Of A Faith-Based Education Program To Improve Clinical Trial Participation Among African Americans, Paula M. Frew, Jay T. Schamel, Kelli A. O'Connell, Laura A. Randall, Sahithi Boggavarapu
Results Of A Community Randomized Study Of A Faith-Based Education Program To Improve Clinical Trial Participation Among African Americans, Paula M. Frew, Jay T. Schamel, Kelli A. O'Connell, Laura A. Randall, Sahithi Boggavarapu
Environmental & Occupational Health Faculty Publications
This is a report of a cluster randomized clinical trial evaluating the effectiveness of a church-based educational intervention aimed at improving African Americans’ (AA) participation in clinical trials. Two hundred and twenty-one AA subjects ages ≥50 years from six predominantly AA churches were randomized to intervention or control condition. The intervention included three educational sessions about clinical trials and health disparities; control participants completed questionnaires. Primary endpoints of the study were differences in individual subjects' intentions to obtain clinical trial information and intention to join a clinical trial, as determined by 10 point scale items at baseline, three and six …
Delivering A “Dose Of Hope”: A Faith-Based Program To Increase Older African Americans’ Participation In Clinical Trials, Paula M. Frew, Saad B. Omer, Kimberly Parker, Marcus Bolton, Jay Schamel, Eve Shapiro, Lauren Owens, Diane Saint-Victor, Sahithi Boggavarapu, Nikia Braxton, Matthew Archibald, Ameeta S. Kalokhe, Takeia Horton, Christin M. Root, Vincent L. Fenimore, Aaron M. Anderson
Delivering A “Dose Of Hope”: A Faith-Based Program To Increase Older African Americans’ Participation In Clinical Trials, Paula M. Frew, Saad B. Omer, Kimberly Parker, Marcus Bolton, Jay Schamel, Eve Shapiro, Lauren Owens, Diane Saint-Victor, Sahithi Boggavarapu, Nikia Braxton, Matthew Archibald, Ameeta S. Kalokhe, Takeia Horton, Christin M. Root, Vincent L. Fenimore, Aaron M. Anderson
Environmental & Occupational Health Faculty Publications
Background: Underrepresentation of older-age racial and ethnic minorities in clinical research is a significant barrier to health in the United States, as it impedes medical research advancement of effective preventive and therapeutic strategies. Objective: The objective of the study was to develop and test the feasibility of a community-developed faith-based intervention and evaluate its potential to increase the number of older African Americans in clinical research. Methods: Using a cluster-randomized design, we worked with six matched churches to enroll at least 210 persons. We provided those in the intervention group churches with three educational sessions on the role of clinical …