Srinivas Murthy, MD, MHSc, FAAP, FRCPC University of British Columbia

Slides:

Advertisements

Similar presentations

Post Research Benefits Mandika Wijeyaratne MS, MD, FRCS Dept. of Surgery, Colombo.

Advertisements

A Process of Quality Improvement: Informed Participation and Institutional Process SACHRP March 27, 2008 Nancy Neveloff Dubler Director Center for Ethics.

Phase O Trials: Ethical Considerations Holly Taylor, PhD, MPH Department of Health Policy and Management Bloomberg School of Public Health Berman Institute.

Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times Michael D. Hill.

Initiating an Antimicrobial Stewardship Program at BC Children's Hospital Quality Forum 2015 Ashley Roberts, MD, M.Ed, FRCP(C) Karen Ng, BSc.Pharm, ACPR,

Cindy Munro, PhD, RN, ANP, FAAN Professor, School of Nursing, IRB Panel A Member, Virginia Commonwealth University.

Maitland K et al ,N Engl J Med 2011;364:

G aps, challenges and opportunities Theo Verheij University Medical Center Utrecht Lower Respiratory Tract Infections in Primary Care.

PPA 691 – Seminar in Public Policy Analysis Lecture 1d – The Belmont Report.

Copyright restrictions may apply JAMA Pediatrics Journal Club Slides: Nebulized Hypertonic Saline for Bronchiolitis Florin TA, Shaw KN, Kittick M, Yakscoe.

Dallas 2015 TFQO: Karen Woolfrey COI #261 EVREV 1: Karen Woolfrey COI #261 EVREV 2: Daniel Pichel COI #513 Taskforce: ACS ACS 873: Pre-hospital STEMI Activation.

1 Obesity Treatment in Special Populations Smokers –All smokers, regardless of weight, should quit smoking. –Implement weight gain prevention, treatment.

International Forum - Quality & Safety in Healthcare |1 | An overview of the Guidance points Ethical issues in Patient Safety Research An overview.

Discussion Gitanjali Batmanabane MD PhD. Do you look like this?

Clinical Trials. What is a clinical trial? Clinical trials are research studies involving people Used to find better ways to prevent, detect, and treat.

Idara C.E.. Three ethical principles guides research with human participants. principle of Autonomy 1. The principle of Autonomy requires investigators.

Journal Club Usha Niranjan SPR Paediatrics/ Diabetes & Endocrine.

Research with Vulnerable Populations Marisue Cody, PhD, RN IRB Chair Training Washington DC, April 9, 2004.

Clinical Trial Designs An Overview. Identify: condition(s) of interest, intended population, planned treatment protocols Recruitment of volunteers: volunteers.

Towards A Care-Bundle For Long-Term Weaning Dr Matthew Jackson Dr Tim Strang & Dr Maria Safar CTCCU, UHSM.

Plymouth Health Community NICE Guidance Implementation Group Workshop Two: Debriding agents and specialist wound care clinics. Pressure ulcer risk assessment.

TERRENCE F. ACKERMAN, PH.D. PROFESSOR OF BIOETHICS CHAIR, UTHSC IRB.

Swiss Re – Pandemic Risk Talk Ethical issues in palliative care for patients with M/XDR-TB Geneva, 19 November 2010 Palliative Care and M/XDR-TB meeting.

Ulla Lønberg – International Safety & Pharmacovigilance – H. Lundbeck A/S21-Feb-2007 Data Monitoring Committees.

The ethical conduct of research with human participants Nancy E. Kass, ScD Department of Health Policy and Management Johns Hopkins Berman Institute of.

Clinical Writing for Interventional Cardiologists.

Vanderbilt Sports Medicine Chapter 5: Therapy, Part 2 Thomas F. Byars Evidence-Based Medicine How to Practice and Teach EBM.

A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit The SAFE Study Investigators N Engl J Med 2004: 350:

The Pharmaceutical Industry and International Clinical Research: One Company’s Approach Michael Clayman, M.D. Vice President, Lilly Research Laboratories.

Development of Health Research Capacity Dr Namrita Mesuria BDS FSMed.

A Practice-Based Intervention to Improve Time-to-Antibiotic Administration in Pneumonia Suspects at Mulago Hospital, Kampala, Uganda Luke Davis, MD Pulmonary.

1 [INSERT SPEAKER NAME DATE & LOCATION HERE] Ethics of Tuberculosis Prevention, Care and Control MODULE 10: RESEARCH IN TB CARE AND CONTROL Insert country/ministry.

How To Design a Clinical Trial

Copyright restrictions may apply JAMA Pediatrics Journal Club Slides: Intermittent vs Continuous Pulse Oximetry McCulloh R, Koster M, Ralston S, et al.

Idara C.E.. Three ethical principles guides research with human participants. principle of Autonomy 1. The principle of Autonomy requires investigators.

A Multifaceted Continuing Medical Education Intervention to Improve Primary Care Physicians’ Performance In Mexico Hortensia Reyes, Ricardo Perez-Cuevas,

Copenhagen University Hospital Rigshospitalet, Denmark

Research Design Evidence Based Medicine Concepts and Glossary.

NIHR Themed Call Prevention and treatment of obesity Writing a good application and the role of the RDS 19 th January 2016.

Education Intervention in the Clinical Setting for Inappropriate Use of Antibiotics in Children Katie Butterfield.

Safety of Albumin Revisited Blood Products Advisory Committee Meeting March 17, 2005 Laurence Landow MD, FRCPC.

Human and Animal Research 1. What issues does this raise? 2.

Risks of Standard of Care (Experimental Aspects of Study) Patrick Herbison Continuing Education for IRB Members.

21 CFR Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006.

Mexican Institute of Social Security A Multifaceted Continuing Medical Education Intervention to Improve Primary Care Physicians’ Performance In Mexico.

Chronic Disease Tracking System  Problem  The current healthcare model focuses on one patient at a time in the office.  Chronic disease leads to higher.

Evidence-Based Dentistry Presenter’s Name. What does EBD mean?

Antibiotic Stewardship of Acute Respiratory Infections in the Emergency Department Acute respiratory infections are a common conditions encountered in.

CRISPR and Regulatory Oversight - through the lens of the IRB - P. Pearl O’Rourke, MD Partners HealthCare Boston, MA.

GCP (GOOD CLINICAL PRACTISE)

November 9, 2015 February 20, 2017 Using real world evidence – industry perspective Pma indication expansion Melissa hasenbank, phd Sr. Clinical Research.

New WHO algorithm to prevent TB deaths in seriously ill patients with HIV Yohhei Hamada TB/HIV and Community Engagement.

How To Design a Clinical Trial

Patient Focused Drug Development An FDA Perspective

Dawn Drahnak, DNP, RN, CCNS, CCRN, Courtney Boast, BS

Strategies to Reduce Antibiotic Resistance and to Improve Infection Control Robin Oliver, M.D., CPE.

Cluster Randomized Trials

Ethical Principles of Research

Ethical Issues in Medical Writing

Issues in Hypothesis Testing in the Context of Extrapolation

Drinking From the Firehose How to keep up with the medical literature while working 80 hours a week. William.

Outcomes of a randomized trial for multimorbidity - the TrueBlue study

A Multifaceted Continuing Medical Education Intervention to Improve Primary Care Physicians’ Performance In Mexico Hortensia Reyes, Ricardo Perez-Cuevas,

Prof Lynn Gillam Children’s Bioethics Centre Royal Children’s Hospital

Jeremy Sugarman, MD, MPH, MA

Scott Berry, PhD Berry Consultants

Forest plots for randomised and cluster randomised controlled trials from Cochrane review Biomarkers as point-of-care tests to guide prescription of antibiotics.

Patient information sheet & Principles of Good Clinical Practice

Monitoring and Evaluating FGM/C abandonment programs

Validity, Specificity, and Reliability Of Informed Consent

Presentation transcript:

Srinivas Murthy, MD, MHSc, FAAP, FRCPC University of British Columbia Critically ill children and adaptive trials for comparative effectiveness research Srinivas Murthy, MD, MHSc, FAAP, FRCPC University of British Columbia Global Forum on Bioethics in Research Bangkok, Thailand November 2017

Disclosures I have no actual or potential conflict of interest in relation to this presentation I sit on local and regional ethics committees I am a clinician and clinical researcher, not a statistician

Background Critically ill children Weak evidence base Expert-based recommendations

Background Acute respiratory failure + Infection Huge disease burden Stated area of need by global community For both pandemic and inter-pandemic periods

Background Research on acutely ill children Parental stress Achieving informed consent Timeliness of interventions

Background Research on acutely ill children in LMICs Resource availabilities

Proposed trial design Population: Critically ill children with acute respiratory failure due to presumed infection Interventions: antibiotics, fluids, oxygen strategies; - comparative effectiveness of frequently used management strategies

Proposed trial design Design: ‘Adaptive’ randomization, ‘platform’ trial Setting: Intensive care units in both low- and high-income settings. Primary Outcome: Either mortality or HRQL-28d

Antibiotic (A) Adaptive Randomization Fluids (F) Oxygen (O)

Comparative effectiveness research “compares the results of one approach for managing a disease to the results of other approaches”* “investigates methods, already in use…to treat a heterogeneity of patients”** *AHRQ, 2009 **BMJ, 2010

Consent models Prospective consent AF O

Consent models Delayed consent Delayed consent +/- Re-consent AF O

Consent models Waived consent Delayed consent +/- Re-consent AF O

Consent models Waived consent Prospective consent +/- Re-consent AF O

Consent models Informed consent for complex trials “…informed of all aspects of the trial that are relevant to the subject’s decision to participate’* -the trial treatment and the probability for random assignment to each treatment *ICH GCP

Consent models Requirements for altering consent -minimal risk -alteration has no adverse effect on participant welfare -impracticable

CE research and waivers/delay of consent Minimal Risk Participant welfare Impracticable ? ✓

Provider autonomy Antibiotic (A) Fluids (F) Oxygen (O)

Questions Is an alteration of consent appropriate for ‘minimal-risk’ interventional studies of this sort? Adaptive randomization is complex, but (likely) benefits study participants. How to build that into informed consent? What further ethical work is required before implementing a trial such as this?

Srinivas.murthy@cw.bc.ca