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INTRODUCTION

5/30/23 - MGR: Opportunities and challenges for conducting clinical trials in low- and middle-income country settings: early lessons from Bangladesh and the HumAn-1 Study

QUIZ

EVALUATION

CERTIFICATE

INTRODUCTION

Credit Hours: CME 1.00

Target Audience:

Faculty, residents, fellows, and community physicians in General Internal Medicine and subspecialties.

Educational Objectives:

At the conclusion of this presentation, you should be able to:

  • Identify the design, rationale and primary objective of a randomized trial comparing analogue versus human insulins among youth with type 1 diabetes living in low and middle income country settings.
  • Improve the benefit/risk profile of patients from lower resource settings who choose to participate in multisite clinical trials
  • Identify early lessons (e.g. do's and don'ts) for clinical investigators seeking to conduct clinical trials from the HumAn-1 study.

Suggested Additional Reading & Joint Accreditation Statement - Note: This Accreditation Statement Supersedes All Other Statements:

Suggested Additional Reading:

  • Alemayehu, Chalachew, Geoffrey Mitchell, and Jane Nikles. "Barriers for conducting clinical trials in developing countries-a systematic review." International journal for equity in health 17 (2018): 1-11.
  • Zabeen, B., Govender, D., Hassan, Z., Noble, J. A., Lane, J. A., Mack, S. J., ... & Ogle, G. D. (2019). Clinical features, biochemistry and HLA-DRB1 status in children and adolescents with diabetes in Dhaka, Bangladesh. Diabetes research and clinical practice, 158, 107894.
  • Mbuagbaw, Lawrence, et al. "The challenges and opportunities of conducting a clinical trial in a low resource setting: the case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial." Trials 12.1 (2011): 1-7.


Joint Sponsor and Accreditation Statement:

In support of improving patient care, this activity has been planned and implemented by the University of Pittsburgh and the Pennsylvania Chapter American Academy of Pediatrics. The University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

The University of Pittsburgh designates this enduring material activity for a maximum of 1.00 AMA PRA Category 1 Credit[s]™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals: Other health care professionals will receive a certificate of attendance confirming the number of contact hours commensurate with the extent of participation in this activity.

Authors:
Bedowra Zabeen, MD, MBBS, FCPS(Pediatrics) — Consultant Pediatrician and Pediatric Endocrinologist, Department of Pediatrics, Coordinator, BADAS Pediatric Diabetes Care and Research Center, Diabetic Association of Bangladesh
Dr. Zabeen receives grant/research support from the University of Pittsburgh, School of Medicine.
Jing Luo, MD, MPH — Assistant Professor of Medicine, Core Faculty | Center for Research on Healthcare, Core Faculty; Center for Pharmaceutical Policy and Prescribing (CP3), Division of General Internal Medicine, University of Pittsburgh School of Medicine
No planners, members of the planning committee, speakers, presenters, authors, content reviewers and/or anyone else in a position to control the content of this education activity have relevant financial relationships to disclose.
No other members of the planning committee, speakers, presenters, authors, content reviewers and/or anyone else in a position to control the content of this education activity have relevant financial relationships with any companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

This activity is approved for AMA PRA Category 1 Credit™

The University of Pittsburgh is an affirmative action, equal opportunity institution.