The risks and benefits of research remain a central consideration in drug development, research design, review and regulation. It’s consequently a central concern within the new proposed EU Clinical Trial Regulations.
Yet there is little evidence on which to build our judgments and found a balanced approach. Without evidence, risks are exaggerated and the benefits played down. Medical and drug development is undermined, researchers are cautious, monitors without clear and appropriate objectives and as importantly potential research participants ill- or un-informed. We all lose. There is therefore an urgent need for re-evaluation and a coordinated approach to resolve these problems. Our conference will explore the consequences of research, both harm and benefit and look how we might achieve a fair balance that promotes improvements in health care, new medicines without diminishing protection of the research participant. It will also explore the current proposal for an EU Clinical Trial Regulation and its consequences.
It will particularly address
• the approaches of the EU, the EC, competent authorities and drug regulators
• roles of funders and sponsors
• how patients, researchers and ethics committees perceive and assess this balance
• how research risk is monitored
• how insurance and indemnity is and will be approached in the EU
• the representation of research risk and benefit in the media
For twenty one years the European Forum for Good Clinical Practice has acted as a forum to bring all parties with an interest in health care research together and debate current topics. It has members and partners in all areas of research so this conference will be an opportunity to contribute to the debate, influence policy and practice.
1. The approaches of the Competent Authorities: How are regulators and member states approaching risks and benefits assessment?
2. Risk management, insurance and indemnity to include the principles of risk assessments and available tools as well as how brokers approach risk assessment
3. The Joseph Hoet lecture on ethics in clinical research: The Media and Research, Risk and Benefit Dr Trish Groves, Deputy Editor, British Medical Journal (BMJ), United Kingdom
4. The views of patients, researchers and ethics committees when considering harms and benefits. What matters to patients? How do researchers and ethics committees perceive and weigh up this balance? On what should they build their calculus?
5. Harms, benefits, risks and the new EU Clinical Trials Regulations