Is paperwork suffocating British clinical research?

摘要

Concerns are being raised by a growing number of British academics that bureaucratic overload is stifling their ability to undertake clinical research, compromising the future of this activity in the UK, and ultimately doing patients a disservice. Before the European Clinical Trials Directive (ECTD) came in to force in 2004, and the corresponding bill bringing it into UK law (The Medicines for Human Use [Clinical Trials] Regulation, 2004), academic medical professionals wishing to undertake a clinical trial had to apply for approval to the local research ethics committees of the geographical areas involved, and to the Medicines and Healthcare Products Regulatory Agency (MHRA) under the Doctors and Dentists Exemption Scheme. The latter involved filling out a short form and providing a general protocol for the trial. Now, researchers complain, UK interpretation of the ECTD has led to the requirement of a detailed protocol (which might reach 100 pages in length) and the answering of over 40 questions on a form spanning 28 pages. An Investigative Medicinal Product Dossier, which might also be 100 pages long, is also required to detail the stability and toxicology of the product to be tested. If the product is to be used in humans for the first time, stability and toxicology studies are necessary from independent laboratories. Even low-risk clinical research, such as imaging trials involving radionuclides, must go through the same channels. Many research groups claim that the gathering of information, required testing, and writing of these documents can take months.