Transparency and Trustworthiness in Drug Development

Over the past few decades or so there has been a move towards a participatory-transparent model of regulation especially in Europe and North America. This call for increased transparency may have been brought about by a number of regulatory scandals, such as the Cox-e2 inhibitor scandal. Some of the key components in this more deliberative and transparent model of regulation is ensuring that the policy-making process is as transparent as possible. This includes making regulatory decision making public, having the pharmaceutical industry share information on clinical trials and other safety related data; and encouraging scientists to debate scientific uncertainties in public.

This course centers on topics that cover some of the contemporary dilemmas affecting transparency, ethics, communication and trustworthiness in the development, approval and use of pharmaceutical products. This is done by:

• Introducing the students to key concepts of bioethics and transparency
• Present and discussing case studies of dilemmas of transparency in drug development and regulatory decision-making
• Introduce and discuss principles for communication of medical benefit-risk decision-making under uncertainty.

The need for transparency and focus on making almost everything transparent if a big trend in these years, and also in regulatory decision- making. Therefore, a lot of information and documents are now available not just to the professionals but also to the public. This makes the knowledge of where and what is available and why key in drug development and not least it poses a dilemma as there is also time-money and proprietary/confidential information to consider. So does transparency come without costs?

There is many ethical considerations present in the development of medicines, but we don’t often revisit the true definition of biomedical ethics, and after gaining work experience being reminded of the definition can often cause new reflections on practice.

Before the course, you will work on 1-2 homeassignments that will be discussed at the course.