Statement on the recent serious adverse events that happened in a clinical trial in France (Guest Blog)
The recent events that occurred in a clinical trial conducted in France, in which one clinical trial subject lost his life and several other trial participants became seriously ill, are tragic. Members of EUCROF, the European Federation of Contract Research Organisations, view these issues with serious concern and regret.
As a federation of companies involved in all phases of drug development, our first thoughts must rest with those subjects who participated in the trial and with their families.
It would be prudent, though, to point out that drug development is one of the most highly regulated areas, with very strict rules aimed at minimising risk for both trial subjects – during each and every phase of the development process – and patients, once the product is on the market.
Perhaps the best way of offering reassurance is to walk through the actual process.
Before a medicinal product is tested in human subjects (clinical trials), in vitro and animal studies (preclinical trials) are conducted. This produces a solid basis of data on which decisions can be made as to whether initial testing in humans is safe.
There is additional and vital oversight as well. Following an in-depth assessment of the existing data, and after carefully weighing potential risks against possible benefits, regulatory authorities and ethics committees give their approval for a clinical trial, require modifications or reject the clinical trial plan (protocol).
First in class medicines pose a challenge to drug developers and legislators in terms of precautions that need to be taken when translating pre-clinical data into safe dose ranges for “first in man” administration.
The reality is that no medicinal product can be placed on the market without extensive testing in humans. The potential dangers would otherwise be unjustifiable.
Events like those that have occurred in France are nevertheless a real shock to the clinical research community and must be carefully analysed and – if need be – give an impetus to an improvement in regulations and guidelines. We would stress, though, that such events are extremely rare and we are also aware that the French authority is doing all it can to determine the root causes. Little is known at this point, and the investigation will hopefully elucidate the origins of the event.
The safety of trial subjects and the potential clinical benefit of medicinal products under development both fall firmly within the remit of EUCROF. We have over 20.000 collaborators and scientists dedicated to drug development, who are fully aware of the great responsibility they share with clinicians in recruiting and following up subjects in clinical trials.
About the authors
Stefano Marini is a Medical Doctor, specialized in psychiatry and endocrinology, with over three decades of experience in drug development and clinical research, mainly managing clinical trials. Since 2010 he is President of EUCROF (European CRO Federation), which includes over 300 companies and over 20.000 employees specialized in clinical trials; Board Member of the Scientific Didactic Council and Lecturer at the II level Master on Clinical Research at Rome University Sapienza, Stefano Marini has founded and managed for 25 years an Italian contract research organization, conducting over 350 clinical trials. Dr. Marini has also spent more than six years at the University of Rome as an investigator, gaining experience with clinical trials in neuropsychiatry and endocrinology. He was with Janssen Italy for over six years as responsible for CNS R&D. He is author of more than 85 scientific articles, and author or co-author of over 170 Clinical and Pharmacotoxicological expert reports for marketing authorizations.
Dagmar Chase graduated in Computer Science with a secondary focus on Theoretical Medicine from the Technical University in Munich and has a PhD in Human Biology from the Medical Faculty of the University in Ulm, Germany. Dagmar Chase co-founded the company GMI, a full service CRO for clinical trials phase II – IV, in 1983. Besides developing GMI into one of the largest CROs in Germany, she concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry. In order to be able to offer international services to GMI’s clients, Dagmar Chase was instrumental in the merger of GMI with the US-based CRO Kendle International Inc (now INCResearch) in 1997, holding the position of vice president until the beginning of 2004. In March 2004, Dagmar Chase started up Clinrex, a consultancy firm for clinical research. Besides providing training, she focuses on Quality Management of clinical trials with a special focus on GCP gap analyses, inspection readiness, investigator initiated trials and working with CROs. She also manages the interface to DSMBs/DMCs.
Dagmar Chase is a co-founder of the German CRO association BVMA, which was established in 1991. She is the president of the BVMA since 2001. In addition, Dr. Chase is a co-founder of EUCROF, the EU CRO Federation and holds the position of vice-president since its inception.