Pro Investigatione Clinica

Swiss citizens have voted in 2010 on a Constitutional Article on research involving human beings, and in 2011 the Swiss Parliament subsequently approved a Law that rules clinical research. A set of Bylaws has been elaborated and is now open to consultation among interested parties.

These bylaws aim at enforcing a set of rather complicated administrative procedures for the organisation and performance of all kinds of clinical trials. Most of these concrete requirements do not rest on dispositions set out in the Law. They are directly derived from "good clinical practice" regulations, originally implemented to control the clinical development of new pharmaceuticals through industry-sponsored trials. Many of them are already implemented in the current Bylaws of the Law on therapeutic products. The legislator now wants to enforce these regulations globally, including for investigator-initiated, low-risk studies not specifically oriented towards drugs development. A distinction is made though between different types of trials, with some simplification of procedures for low-risk trials of interventions with already approved indications.

This project of Bylaws triggers concerns among clinical researchers working in the public sector, high schools and university hospitals. The procedures described will certainly be applicable to pharmaceutically driven research, which already follows comparable regulations. However, despite the distinction mentioned above – that we welcome, – the applicability of industry-inspired procedures is questionable in case of investigator-initiated clinical investigations without commercial sponsor, regularly supported by and performed in the public sector. Such studies are of definite importance for public heath, as they complement industrial research with observations bringing responses to unanswered medical questions, for example: elucidation of physiological mechanisms, evaluation of diagnostic tests, comparison between actual therapeutic alternatives, possibility of treatment simplification, or inconvenience of certain therapies. These studies typically benefit from limited financial support and human resources, as they are disregarded by both pharmaceutical industries (in the absence of beneficial effects on sales) and public funders (not keen to support research on profit-generating drugs). They are often performed on a voluntary basis by busy physicians in training, in addition to usual patient care. The indiscriminate enforcement of a complicated, time-consuming and costly apparatus of procedural requirements would undoubtedly have detrimental effects on this type of research, and on the efforts of the academic community to keep medical diagnosis and treatments rational, simple and safe.

The present petition addresses this issue by asking that investigator-initiated non-profit clinical research performed in the public sector (universities, high schools, public hospitals and clinics) and using interventions with already approved indications, to be spared the burden of having to comply with the same set of "good clinical practice" rules and procedures as defined for industrially-driven trials. The law must certainly be the same for all clinical investigations, but the way to enforce it must be appropriate to the context.

You may want to sign it if you are a health professional working in a Swiss public institution and involved in clinical research, and if you agree with the demand below.