All medicines need to pass rigorous tests before they can be used by doctors.

The safety of a medicine (or other form of treatment) and how well it works are tested in clinical trials. Clinical trials are studies involving patients. The safety and effectiveness of new medicines are compared to existing medicines or a placebo (a ‘dummy’ medicine). Researchers monitor trials closely and make sure nothing harmful happens to the patients on the trial.

Due to legal requirements, clinical trials have become more and more complex and expensive, with lots of paperwork and inefficient processes.

Because of this, fewer clinical researchers can afford to run non-industry-sponsored clinical trials. Bureaucracy limits the time that clinical researchers can dedicate to their patients. Paperwork draws their attention to irrelevant details, which makes it more difficult for doctors to focus on the important things, such as safety, and use their time efficiently. This inefficiency can result in poor quality studies and may put patients’ safety at risk.

Action Kidney Cancer are members of the Coalition for Reducing Bureaucracy in Clinical Trials.

The Coalition started as a group of clinical researchers in haematology, who published a paper in the British Medical Journal (BMJ) warning about the increasing administrative burden in clinical trials. The Coalition has grown to include medical societies and patient organisations.

The Coalition Statement was published in September 2020. Working groups were formed with experts on safety reporting, informed consent, regulatory, and a policy group who developed the Coalition Recommendations in November 2021. Since then, the Coalition has worked to increase awareness of these recommendations.

The Coalition works closely with its members and with other groups, such as the Good Clinical Trials Collaborative (GCTC), to reduce bureaucracy in clinical trials, both for clinical researchers and patients.

The Coalition has been working with contract research organisations (CROs) and Ethics Committees in Europe with an aim to discuss how to move forward with the Coalition Recommendations. There  have been roundtable meetings to focus on: informed consent, safety reporting, and regulatory guidelines. They reached out to sponsors and CROs, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of Clinical Research Organisations (ACRO) and have developed a patient-friendly informed consent form template for clinical trials.

The Coalition responded to the recent Good Clinical Practice Guidelines consultation and are in contact with European Medicines Agency (EMA), where they have presented the Coalition Recommendations, safety reporting, informed consent forms as well as harmonisation of guidelines and regulatory documents across Europe. The Coalition has been working with the Good Clinical Trial Collaborative (GCTC) on the current Good Clinical Practice Guidelines consultation:

  • Patient consent forms are often too long and too complex, written in legal language and containing information that is difficult to understand and unnecessary for patients. Informed consent forms must be easy to understand and include only what is essential for patients.
  • Safety reports often include too much information. Some of this information is essential, but much of it is irrelevant, making it harder for the doctor to focus on what is really important for the patient’s safety. Safety reporting needs to be simplified and improved.
  • Over-interpretation of official guidelines by the companies that organise clinical trials. Vague guidelines that leave too much room for interpretation are an important cause of (unnecessary) bureaucracy. The Coalition is asking regulators (the government agencies responsible for overseeing the quality and safety of the development and testing of medicines) to make sure their guidelines are clear, concrete and consistent.

If you would like to know more about the work of the Coalition for Reducing Bureaucracy in Clinical Trials, please email us.

Read a patient-friendly version of the Coalition’s 2025 Recommendations here