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krista28 14th September 2017 10:49 PM

Clinical trial disaster
So i am currently working on a clinical trial for pain management after 3rd molar extraction.We recently had a patient down who had the surgery but the trial was having issues with their data transfer system so it took him two hours before he got any meds. This was not my fault and has recently been fixed.

So the patient took the meds and he left the office with instructions to take the meds and fillout an electronic diary i provided him. The next day i called to do my follow up and he said his throat started closing up and that he almost died and took a bendryl to stop the reaction. He said he only took two pills.

I had the doctor call him and he said keep those meds as far away from yourself as possible. I then spent the next two months trying to get the drug company to tell me what meds he was on... they finally did as he said he was going to get them tested at a lab if we didnt tell him. So we told him. And he still wouldnt return them. I had 4 or 5 people try.

One person from her personal cell so he wouldnt see our company name. She was able to get the meds back from his girlfriend. Before she handed the meds to my friend she said I punched some of the pills out to get then tested because I dont believe what the doctor said.

When we got the pills back he had almost taken his full treatment course. He never went to the hospital and thought he could make up a lie to get money from the rx company. Is there any recourse? He lied to myself and the physician.

LivingWaterPlease 14th September 2017 11:26 PM

Do you mean any legal recourse because he lied? If so, I doubt it but you need to check with an attorney to be sure.

Why wouldn't you want to just drop him from the trial rather than retaliate? What would be the point in recourse?

TheFinalWord 15th September 2017 1:11 AM

Are you in the United States? There is a lot of legality wrapped up in clinical trials. Protocols for treatment administration and deviations from the approved protocol should be reported and documented.

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