Bioethics of clinical innovation and unproven methods Copenhagen, 9 April 2019

The conference was organized by the Nordic Committee on Bioethics in collaboration with Centre for Legal Studies in Welfare and Market at the University of Copenhagen.

Below you can see the conference program - see slides from each talk by clicking on the titles. Abstracts for each talk can be found here. The conference was filmed - you can find the playlist here

Clinical innovation involves development of new techinques, methods, treatments and diagnostics for detecting, alleviating and curing diseases. By nature novel clinical methods and treatments are unproven when first developed. Through the centuries, medicine has advanced by trials and errors of physicians and researchers experimenting with treatments and methods. The failure of certain methods are inseperable from success of others, because a priori it is hard to know what works and what does not. The scientific method is the preferred approach to develop cures and treatments, but many current medical practices were not developed by strict scientific testing or trials. Healthcare professionals may try unproven methods, for instance as a last resort in attempt to safe a life. Such unproven methods for clinics and health care, occur at the intersect of basic research and standard health-care and raise number of bioethical issues. Those include the following issues. Do patients have sufficient and equal access to the experimental methods? Are patients protected from harm when unproven methods are tested? Who should make decisions about when to experiment with a treatment? How can society and the health care system best simultaneously promote clinical innovation and protect patients?

Conference program

Session 1 - How are clinical innovations/unproven methods developed and introduced?
"Ethics and Policy Surrounding Patient Access to Experimental Therapy", Professor Jonathan Kimmelman, Director of Biomedical Ethics Unit, McGill Uiversity, Canada
Experimental oncolytic immunotherapy for individualized treatment of cancer patiets incurable with routine approaches , Professor 
Akseli Hemminki , University of Helsinki, Finland
Developing a cancer vaccine, and challenges in performing clinical trials of experimental therapies” ,
Professor Steinar Aamdal, University of Oslo, Norway
We can do better - a patient perspective”, Anne Sofie Boldsen Salicath, MD, Patient group representative, Denmark

Session 2 - What is the legal and regulatory environment concerning clinical innovations in medicine?
"The room for clinical innovation under Swedish law ", Senior Lecturer Lena Wahlberg, Lund University, Sweden
The regulatory challenges in regards to clinical innovation, Professor Mette Hartlev, University of Copenhagen, Denmark
"Regulating Risk in Surgical Innovation? A UK perspective", Dr. Jonathan Ives, University of Bristol, UK

Session 3 - What ethical principles should guide work on emerging treatments and experimentation in hospitals? 
"Novel medical treatments, innovation, hope and headlines", Catherine Joynson, Assistant Director, Nuffield Council on Bioethics, UK
"Harms and benefits in clinical innovation", Dr. Gardar Arnason, University of Tübingen, Germany
"Ethical principles in unproven methods – is there a need for regulations?", Professor Ingemar Engström, Örebro University/NCBio, Sweden