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Yes. The treatment in clinical studies can cause adverse effects as can the treatment of your medical condition outside a clinical trial. The nature and extent of side effects, however, depends on the tested therapy and individual patient characteristics. Chemotherapeutic agents in particular, which are effective against aggressive tumour growth, are often harmful to healthy tissue cells. Well known side effects include hair loss, mucosal infections, nausea and changes in blood biochemistry. Long term adverse effects such as infertility and organ damage, e.g. heart and lung, are also possible. New, so called ‘small molecules’ anti-cancer drugs and monoclonal antibodies which are mostly more tolerable than chemotherapeutics, may also cause adverse events, e.g. allergic reactions, skin rash and diarrhoea. Prior to commencement of a clinical trial, you will be informed by study doctors of all side effects and their possible treatment. To recognise early side effects and initiate counter measures, patients are closely monitored throughout clinical studies.

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