Uncertainties and Risk in Planning Translational Trials

Uncertainties and Risk in Planning Translational Trials:

North American and Swedish Stakeholders’ Experience of Initiating Early Phase Trials

Lead Investigators: Jonathan Kimmelman & Hannah Grankvist

Funding Agency: The Swedish Council for Working Life and Social Research

Term: January 2013-June 2015

INTRODUCTION

Introducing novel interventions into clinical testing presents numerous technical, social and ethical challenges. Phase 1 trials of novel agents in translational medical research lack established ethical or technical frameworks for guiding their initiation and conduct. Consequently, such studies present two recurrent questions: when should human trials be initiated, and how should they be designed? This grant aims to understand the way stakeholders define scientific significance and clinical relevance in planning early phase trials. It will look at decision-making among key stakeholders in two translational medical arenas: cell therapy for Parkinson’s disease and drugs targeting cancer stem cells. Our study will allow us to explore factors that drive decision-making and the effects of scientific controversy on trial decision-making.

DESIGN

The present study will examine these questions empirically by performing interviews with preclinical researchers, early phase trial investigators and independent expert researchers in two translational arenas: cell therapy for Parkinson’s disease and drugs targeting cancer stem cells. Each translational arena will be examined in North America and Sweden. Approximately 36 interviews will be conducted. The interviews will be semi-structured, audiotaped and transcribed. The collected data will then be analysed using both a content analysis and an ethical analysis.

PROTECTION FOR PARTICIPANTS

Our protocol has been reviewed and approved by McGill’s Institutional Review Board (IRB). Informed consent will be obtained before the interview. Interviews will be audiotaped and transcribed. To ensure that the participants’ identities are kept confidential, we will remove their name from any transcripts and conceal their position. Participants’ identities on the recorded interviews and the transcripts of them will be anonymous. No identifying information will be published.  Though all attempts will be made to conceal identity, it is still possible that others may be able to infer the identity of some respondents, given the small number of individuals active in the two research arenas we are studying.

WHO WE ARE

This study is being led by Jonathan Kimmelman, head of the STREAM research group and Associate Professor in the Biomedical Ethics Unit / Social Studies of Medicine department at McGill University and Hannah Grankvist, a postdoctoral fellow in the Biomedical Ethics Unit at McGill University and the Department of Thematic Studies – Technology and Social Change at Linköping University.

Questions

Should you have questions or concerns about our study, please contact jonathan.kimmelman@mcgill.ca or hannah.grankvist@liu.se.

2013 November 4 | Leave a comment

@Manual{stream2013-433,
    title = {Uncertainties and Risk in Planning Translational Trials},
    journal = {STREAM research},
    author = {Hannah Grankvist},
    address = {Montreal, Canada},
    date = 2013,
    month = nov,
    day = 4,
    url = {http://www.translationalethics.com/uncertainties-and-risk-in-planning-translational-trials/}
}