Details
The U.S. Food and Drug Administration (FDA) has tasked the Sentinel Operations Center (SOC) with conducting reviews of the medical literature related to cannabis use in order to inform some of the work of FDA’s Center for Drug Evaluation and Research (CDER). The specific aims of these literature reviews are to:
- Evaluate and interpret the literature of observational and (except where noted) interventional studies of delta-9-tetrahydrocannabinol (THC)-containing cannabis or cannabis formulations to:
- Evaluate the evidence on harms from nonmedical use, relative to nonmedical use of comparator drugs and relative to non-use, by examining observational studies only.
- Evaluate the evidence on harms from cannabis medical use. Harms associated with the use of medical cannabis include, but are not limited to, psychiatric or behavioral reactions, central nervous system depression, neurological conditions, cardiac conditions, gastrointestinal conditions, and cannabis use disorder.
- Evaluate the harms from cannabis use, where the intent of use is uncertain, by examining observational studies only.
- Critically evaluate observational and interventional studies that assess the effectiveness of cannabis for various therapeutic uses.
Contributors
Amie Goodin, PhD; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Lauren Adkins, MLIS; Jungjun (June) Bae, MS; Serena Guo, PhD; Yan Wang, PhD; Almut Winterstein, PhD, FISPE; Tianxiao Zhang; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Dominic Chiapperino, PhD; Steven Galati, MD; Joshua Lloyd, MD; Controlled Substance Staff, Office of the Center Director, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Catherine Callahan, PhD, MA; Christina Greene, PhD; Sara Karami, PhD, MPH; Kira Leishear, PhD, MS; Tamra Meyer, PhD, MPH; Dave Moeny, RPh, MPH; Silvia Perez-Vilar, PhD, PharmD; Rose Radin, PhD, MPH; Suhkminder Sandhu, PhD, MS, MPH; Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Patricia Bright, PhD, MSPH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Judith C. Maro, PhD, MS; Ryan Schoeplein, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Project 2 & 1B: Additional Contributors
Literature Screening, Data Extraction, and Contributing Authors
Shao-Hsuan (Brendan) Chang; Merial Chatila; Hung-Kai (Henry) Chen; Lena Froehlich; Nicole Gaizo; Dawei Guan, MD; Wenxi Huang; Sebastian Jugl, RPh; Pareeta Kotecha; Priyanka Kulkarni; Thorben Kurzbach; Hsin-Yueh (Shawn) Lin; Nele Melcher; Earl Morris, PharmD, PhD; Crystal Naranjo; Shu Niu; Sophia Pliego; Peggy Poelzing; Munaza Riaz, PhD; Ruba Sajdeya, MD, PhD; Milan Scott; Kayla Smith, PharmD; Eva Spin; Laura Springer; Huilin Tang; Yehua Wang; Jordyn Wiener; Tianxiao (Tom) Zhang; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Data Extraction for Uncontrolled Studies
Cristina Alberti; Greta Apolstoli; Kavitha Maria Davis; Jennifer Estrellado; Payton Evans; Lauren Finch; Joshua Godefoy; Lanz Golez; Amanda Gore; Ashton Hagen; Yaima Jimenez Hernandez; Dayanna Herrera; Grace Hufford; Emily Johnsen; Yuliya Joseph; Jamie Maxwell; Ivette Solis Nolasco; Colin O’Connor; Daniela Puig; Yiyuan (Michelle) Qu; Paakhee Shah; Ryan Tran; Thy Tran; Dalyn Valentin-Shawver; Diya Sunil; Uyen Van; Anson Yeow; Jing Jie Yu; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Project 1A & 1C: Additional Contributors
Data Extraction and Review Contributing Authors
Greta Apostoli; Jungjun Bae, MS; Shayan Bassir; Kavitha Davis; Anjalika Eeswara; Jennifer Estrellado; Celeste Ewig, PharmD; Mikaela Foster; Lena Froehlich; Almina Gomez; Amanda Gore; Taylor Grove; Christopher Guibernau; Ashton Hagen; Dayanna Herrera; Grace Hufford; Yaima Jimenez; Eli Jorgensen; Yuliya Joseph; Hedieh Kouchak; Thorben Kurzbach; Deyaneira Laboy Baiz; Joshua Levine; Jamie Maxwell; Nele Melcher; Minh Phan; Yiyuan Qu; Blaire Reece; Maria Reilly; Hannah Reynolds; Paahkee Shah; Dionna Shine; Lindsay Solano; Ivette Solis Nolasco; Laura Springer; Diya Sunil; Thy Tran; Uyen Van; Carole Yazaji; Anson Yeow; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL
Sruthi Adimadhyam, PhD, MS; Sarah Alam; Taliser Avery, MS; Kimberly Barrett, MPH; Jillian Burk, MPH; Whitney Chlon, MPH; John Connolly, ScD; Christian Hague, MPH; Josh Harvey, MPH; Rebecca Hawrusik, MS; Casie Horgan, MPH; Caroline Hugh, MPH; Maria Kempner; Joy Kolonoski, MPH; Jennifer Lyons, PhD, MPH; Kshema Nagavedu, MPH; Sampada Nandyala, MPH; June O’Neill, MPH; Katherine Round, MPH; Ryan Schoeplein, MPH; Kathleen Shattuck, MPH; Mayura Shinde, DrPH, MPH; Andrew Simon, ScM; Elizabeth Siranosian; Samantha Smith; Thuy Thai, PhD; Amelia Thyen, MPH; Neha Varma, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Literature Screening
Cristina Alberti; Francis Ameng; Sonali Chikersal; Zalina Delisi, Payton Evans; Gisselle Halabi-Molli; Taabris Jaamal; Marion-Ian Javier; Emily Johnsen; Diana Kretschmer; Gerald Loyola; Eisha Ludtke; Seth Malhotra; Aicha Ndiaye; Colin O’Connor; Aaliyah Parchment; Tolulope Sadiku; Makenzie Steidl; Ryan Tran; Madison Weber; Eugenia Woods; Caitlin Young; Department of Pharmaceutical Outcomes & Policy, Department of Epidemiology, College of Pharmacy, University of Florida; Consortium for Medical Marijuana Clinical Outcomes Research, Gainesville, FL