For patients

WHAT IS THE PROBLEM?

All medicines need to pass some tests before any doctor can use them.

The safety of a medicine (or other form of treatment) and how well it works are tested in clinical trials. Clinical trials are studies that involve patients and/or healthy volunteers. Participants are allocated, at random (‘by chance’), the test medication or a placebo. A placebo is usually a fake medication that contains no active ingredients. Some trials use an already existing treatment for comparison, instead of a placebo. Researchers monitor trials closely and make sure nothing harmful happens to trial participants.

Over the last few years, clinical trials have become more and more complex and expensive, with lots of paperwork and inefficient procedures, because of legal requirements.

As a consequence of the growing ‘bureaucracy’ and costs, fewer academics and clinical researchers can afford to run non-commercial clinical trials. Bureaucracy limits the time that clinical researchers can dedicate to their patients. It is not that researchers do not want to spend time on reporting safety issues. On the contrary: patient safety is their first concern! The problem is that the paperwork draws their attention to irrelevant details, which makes it more difficult for doctors to focus on the important things and use their time efficiently. This inefficiency can result in studies of poorer quality and puts patients’ safety at risk.

WHAT MUST BE DONE?

Researchers, doctors and patient advocates across disease areas call for urgent actions to reduce paperwork and move towards better, more patient-centered and cheaper clinical trials.

The ‘Reducing Bureaucracy in Clinical Trials’ coalition of researchers, doctors and patients is trying to address especially the following burning issues:

• Safety reports often include too much information. Some of this information is essential, but much of it is irrelevant and uninformative, making it harder for the doctor to focus on what is really important for the patient’s safety.

Safety reporting therefore needs to be simplified and improved.

• Patient consent and re-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 (re)consent forms must be easy to understand and include only what is essential for patients.

• Over-interpretation of official guidelines by the companies that organize 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.

These problems can only be solved with the help of governments (EU and national), pharmaceutical companies, ethics experts and other parties that can influence how clinical trials are done. Our Coalition of researchers, doctors and patients has formulated a number of recommendations as the basis for discussion and collaboration with these ‘stakeholders’.

Clinical trials run during the COVID-19 pandemic have demonstrated that what we are asking for is possible and does not jeopardize quality health care.

Will you join us?

The coalition welcomes endorsement by patient organizations! Please contact the coordination team at bureaucracyinCTs@ehaweb.org.