01.02.2022 – 23:30
European Hematology Association (EHA)
The Hague, Netherlands, June 12 /PRNewswire/
Reducing the administrative burden in the interests of quality and patient safety
Clinical trials are research studies conducted on volunteers to evaluate the safety and effectiveness of new drugs and therapies. Your results are used by the regulatory authorities to decide on approval. Conducting clinical studies is becoming more and more difficult and expensive, which is mainly due to the disproportionately high bureaucratic effort. This increasing complexity is a threat to patient safety, independent academic clinical research, and access to affordable innovation.
This situation led to the formation of a broad, multidisciplinary coalition of medical societies and patient advocacy groups to combat red tape while ensuring trial quality and patient safety. The “Recommendations of the coalition for reducing bureaucracy in clinical trials” 21><27(“Coalition Recommendations”) focus on four main topics: safety reporting, informed consent, regulatory guidance and harmonization of requirements across the EU.
The current practice of safety reporting means that physicians have to spend a significant amount of their time on administrative tasks. Ideally, investigators should only focus on the medical aspect of the adverse events, ie those elements directly related to the patient and the disease.
Informed consent forms are often long and written in legal language that can be difficult for patients. The coalition therefore recommends limiting patient consent forms to 1000 words and using layperson-understandable language and data visualization whenever possible.
The coalition’s recommendations are also a call to reduce over-interpretation of regulatory guidelines, to harmonize ethics and data requirements across the EU, and to focus on better study designs that include cumulative safety reporting and take into account patients’ views.
While the coalition’s recommendations primarily reflect the views and needs of investigators and patients, the views of regulators, sponsors, ethics committees and other stakeholders have also been taken into account as far as possible. The coalition remains engaged in dialogue and cooperation to find realistic, pragmatic and broadly based solutions.
The leader of the coalition and the board member of the EHA Prof. Martin Dreyling: “The Coalition’s recommendations are a clear call from patient groups, investigators and academic sponsors to limit the administrative burden of clinical trials, which is currently disproportionate and poses a risk to trial quality and patient safety. Above all, our interdisciplinary coalition calls for cumulative reporting (rather than individual SUSAR reports), legible and concise patient informed consent forms, and a regulatory framework that focuses on the primary study objective (as with studies in the COVID-era).”
Die European Hematology Association (EHA) is a non-governmental organization dedicated to promoting excellence in hematology in patient care, research and education. In close cooperation with the BioMed-Alliance, the EHA initiated and coordinated the coalition to reduce bureaucracy in clinical trials. For more information about the EHA and the Coalition to Reduce Clinical Trial Bureaucracy, please contact Gauthier Quinonez at [email protected]
Coalition website: https://bureaucracyincts.eu/
Gauthier Quinonez – [email protected] – Tel: +31 (0)70 3020 099
Original content from: European Hematology Association (EHA), transmitted by news aktuell