What happens when a trial patient needs to claim compensation for a Serious Adverse Reaction?

How many of us have been in a situation where we have seen a patient genuinely injured by their participation in a clinical trial? In the 20 years I have worked in oncology trials, I was one of the many of us who had never seen this - until now. For the first time, I am now supporting a patient who has genuinely been medically impacted via a confirmed Serious Adverse Reaction to an IMP within a clinical trial. The chances of it happening are so slim many of us will be unprepared for how to manage it. But being ready, knowing what to do, knowing how to support your patient and how to advocate appropriately on their behalf is incredibly important, both for your patient and for your organisation. I will be developing a set of processes and policies over the coming months to ensure the correct pathway is followed at all times and I will be doing this in conjunction with the patient, as I believe their voice is the most powerful one we need to hear. I will be updating key documents and pathways for anyone to download freely from my website and more importantly, I will ensure the patient persepctive is heard. Please reach out if you would like to learn more about how to support patients who are claiming against the Sponsor insurance policy for a Serious Adverse Reaction.


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Sophie Mepham provides Good Clinical Practice education, training, auditing and resources, especially designed for hospitals, research institutes and clinical trials staff.

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