EHA: Recommendations of the Coalition for Reducing Bureaucracy in Clinical Trials

Cutting back administrative burdens in the interest of quality and patient safety

THE HAGUE, Netherlands, Feb. 1, 2022 /PRNewswire/ -- Clinical trials are research studies performed in volunteers that are aimed at evaluating the safety and efficacy of new medicines and therapies. Their results are used by regulatory agencies to decide on marketing authorization. Clinical trials are becoming increasingly difficult and expensive to conduct, due in great measure to the disproportionate volume of bureaucratic demands involved. This growing complexity is a threat to patient safety, independent academic clinical research, and access to affordable innovation.

This situation prompted the formation of a broad cross-disciplinary coalition of medical societies and patient advocates to combat excessive administrative burden whilst ensuring clinical trial quality and patient safety. The "Recommendations of the Coalition for Reducing Bureaucracy in Clinical Trials" ('Coalition Recommendations') focus on four main themes: safety reporting, informed consent, regulatory guidelines, and harmonization of requirements across the EU.

Current safety reporting practices lead doctors to spend a significant portion of their time on administrative tasks. Ideally, investigators should have to focus only on the medical aspect of adverse events – i.e., those elements directly related to the patient and the disease.

Informed consent forms are often lengthy and written in legal language that can be challenging for patients. The coalition therefore recommends limiting patient consent forms to 1000 words, using lay language and data visualization where possible.

The Coalition Recommendations are also an appeal for reducing over-interpretation of regulatory guidelines, for harmonization of ethics and data requirements across the EU and for focusing on better trial designs which include cumulative safety reporting and take into account patients' views.

While the Coalition Recommendations reflect first and foremost the views and needs of investigators and patients, the views of regulators, sponsors, ethics committees and other stakeholders have been taken in as much as possible. The Coalition continues to engage in dialogue and collaboration in search of realistic, pragmatic and broadly supported solutions.

Coalition lead and EHA Board Member Prof. Martin Dreyling: "The Coalition Recommendations are an unambiguous call by patient advocacy groups, investigators and academic sponsors to limit the administrative burdens in clinical trials, which are currently disproportionate and a threat to trial quality and patient safety. Our interdisciplinary Coalition especially asks for cumulative reporting (instead of single SUSAR reports), readable and short informed consent forms for patients, and regulatory frameworks that focus on the primary study aim (as with trials in the COVID era)."

The European Hematology Association (EHA) is a non-governmental organization that is guided by its mission to promote excellence in patient care, research, and education in hematology. EHA, in close collaboration with the BioMed Alliance, has initiated and coordinates the Coalition on Reducing bureaucracy in Clinical Trials. For more information on EHA and the Coalition for Reducing Bureaucracy in Clinical Trials, please contact Gauthier Quinonez at bureaucracyincts@ehaweb.org.

Coalition website: https://bureaucracyincts.eu/