About Me

I am writing this blog with hope to bring awareness of how participants in clinical trials are treated by drug companies, investigators, Institutional Review Boards (IRB) and the Food and Drug Administration (FDA). While I always understood that a clinical trial is not medical treatment, participants are still entitled to be treated with honesty and respect. I don’t know if my experience is unique. I hope others will write about their experience in trials. I am starting with my experience with the Sponsor (Galmed Pharmceuticals Ltd, Tel Aviv Israel). Later I will add my experience with Investigator (Jefferson Hospital, Philadelphia PA), as well as everything I have learned about FDA. I will suggest what to look for in Informed Consent that participants must agree to at the outset.

The main purpose of this blog is to exchange information about various clinical trials, in particular focusing on Non-Alcoholic Steatohepatitis (NASH). If you search on clinicaltrials.gov for NASH and recurring, 300 trials come up with 100 in U.S. Unfortunately no one is going to help you evaluate a study that an Investigator may recommend. Investigators have their own priorities and the best study for you may not be available to them. Hard as it sounds, it can be done even by a patient with no medical background. Sometimes the best decision is not to participate in a trial even when the Investigator will try to scare you into enrolling. There is big money in clinical trials for Investigators, not much for participants.

The purpose of this blog is not to offer medical advice. It is about sharing experiences and learning about different trials. Many things will happen in the NASH space in the next few years. In my opinion a drug that treats NASH should also reduce fibrosis as well. You as a patient have no friends in this industry. You are a volunteer guinea pig. The only person that will look after your best interests is you.

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