Europe Unveils Plan to Standardize Clinical Development

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-10-01-2014, Volume 23, Issue 10

A Medical Technology Working Party is established to promote collaboration and dialogue on the specific aspects of clinical standards.

The European Forum for Good Clinical Practice (EFGCP) and MedTech Europe have established a Medical Technology Working Party to promote collaboration and dialogue between all stakeholders on the specific aspects of clinical standards. Setting effective ethical and quality standards for medical technology is critical to ensuring that patients have access to safe and effective treatment, according to a joint statement. The group will strive to ensure these standards are broadly accepted and reliably introduced in the diverse medical technology landscape.

"Historically, the clinical development debate has focused on pharmaceuticals," said EFGCP Chair Ingrid Klingmann, MD. "But it's important that we have a deeper conversation about issues that need to be considered when setting standards for the medical technology sector."

The working group will initially organize a joint workshop on "Mitigating Risks in the Lifecycle of Medical Devices: Options and Challenges in the Medical Device Legislation." The workshop, to be held Dec. 4 in Brussels, will bring together patients, national competent authorities, ethics committees, lab technicians, healthcare professionals, industry representatives, and European regulatory authorities with the aim of finding consensus on key topics of interest and potential policy recommendations.

Tensions in research

Meanwhile, EFGCP has revealed more details about the theme of its upcoming annual meeting in Brussels on Jan. 27-28, 2015. Delegates will discuss the inherent tensions between confidentiality and transparency in health research, and the organizers aim to provide a description and report on data protection arrangements in research across the EU through an ethics survey. They also want to encourage debate on a draft statement about the secondary use of data in research and on how the EFGCP's report and recommendations will be provided to those involved in the legislative process.

These two key questions will be addressed: How do we improve health without betraying confidentiality within current and upcoming EU regulations? What is the price of maintaining confidentiality for patients in health research?

Many advances in healthcare are founded on the use of personal data, such as medical records; without access to the data, medical progress would be seriously impeded, organizers of the 2015 annual conference said.