“The ABPI would like to express our deepest sympathy with regards to the tragic incident in France and our thoughts are with the individuals and their families."
15 Jan 2016 Posted in ABPI statement By Dr Virginia Acha
"Phase 1 studies for non-cancer medicines in healthy volunteers are an important part of the medicines development process for the pharmaceutical industry. They do not offer any clinical benefit to trial participants, but are carried out to determine safety in humans and to determine how the human body reacts. It is important for the pharmaceutical industry to characterise safety and toxicity at this early stage. Without this information critical decisions as to whether a medicines should be further developed for use in patients cannot be made.
"In the UK the pharmaceutical industry conducts Phase 1 trials within the framework of European regulations, UK laws and guidelines. Trials must undergo review and approval by the drug regulators and ethics committees before a study can recruit any volunteers. Volunteers can only be recruited if they meet the eligibility and screening criteria. In addition, volunteers must be able to consent and be fully informed about the purpose and risks of the trial. These safeguards are all in place to protect the safety and well-being of the volunteers.”