How safe is a clinical study?

You are in good hands

How safe is it for me?

By the time we start up a study investigating a new medicine at SGS CPU, the application has been reviewed by a large number of people. The sponsor, our doctors, an independent ethics committee and national/international health authorities all independently need to give their approval. Only when all of these people and organisations are convinced that the clinical study investigating a new medicine can be conducted safely, it can be started. Your safety is also our absolute priority throughout the entire study from the start to the end. 

 

External approvals

Any clinical study is thoroughly assessed before its start by various authorities, including an independent ethics committee. This group consists of diverse healthcare experts. They review all the details of the study proposal and will perform a risk-benefit balance.  

  • An ethics committee assessment includes various important questions e.g. about its scientific design and whether the proposed study is scientifically and ethically justified. 
     
  • The committee reviews whether the protocol is complete, the researchers have the necessary expertise, whether the participants will be safe, the information provided to them is complete, the voluntary nature of participation (according to the Clinical Trials Act of 7 May 2004, Art 11, § 4 and the Law of 7 May 2017) and whether the dignity, rights and privacy of the participants are safeguarded. 

The ethics committee follows international guidelines for human research in its assessment. These guidelines are outlined in the World Medical Association (WMA) Declaration of Helsinki and Good Clinical Practice (GCP). The World Health Organisation (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide the regulatory framework. The ethics committee also follows all relevant laws and requirements of Belgium and European authorities and respects the guidelines of the Belgian Advisory Committee on Bioethics and of the National Council of the Order of Physicians.  

Alongside the ethics committee, all clinical studies in Belgium need approval from the Federal Agency for Medicines and Health Products, also known as the FAMHP. Next to this, the clinical study also has to meet the stringent requirements set out in the European Union Clinical Trials Regulation.

Important: a positive opinion of an ethics committee or the FAMHP should never be the only encouragement for you to take part in a study. Any pioneer's decision to take part in any study is independent and voluntary.  

Inside our research centre   

Your health is always our main focus during and after administration of the study medicine. This is why you will be closely monitored by experienced, qualified medical personnel. You will be monitored continuously through various tests guided by the investigational molecule (small, active component of the medicine). Examples of tests are ECG (heart trace), blood pressure, heartbeat, temperature, breathing rate, blood tests, urine tests, ... If there are any abnormal findings at any time during the study, the doctor will discuss this with you immediately and take appropriate action if needed.  

Our research centre in Edegem is located on the grounds of the Antwerp University Hospital (UZA) campus in close proximity of the Emergency Department. If needed, the Emergency Department staff will come straight to our facility to support us and help you. Finally, our staff, the ethics committee, national/international authorities and the sponsor continuously supervise the study. They will take immediate action, if, for example, the treatment causes more frequent or more serious side effects than anticipated.