No, I was in this study. It was an ADHD study for generic . We had two check ins. 4 groups total and "luckily" I was in the first round and was able to finish. The girl was young (19). Very quiet and pleasant demeanor.
Anyhow, for the first check in she seemed healthy enough, the study doctor informed our group her vitals were healthy with no repeats. Come the second week, she didn't check back in, the day of taking our second dose, the doctor informed us she had passed. Very somber event. You can imagine our group was in shock and had tons of questions. We were told she passed the previous day, a full 7 days post our original check in. The doctor did share that detectives on the case suggested foul play and drugs were involved. So although still vague on my groups end, we all ued and it's not much we could do since we dosed already. We were just heavily monitored with tons of feel checks.
The 2nd group checked in the next day and ended up having to go home and then the study doctor cancelled the entire study for precautions sake and quote, "although he is sure it was not the drug, there is always the slight chance". I get it and damage control for any potential lawsuits I suppose.
Word got around the floor quick and rumors sprouted up almost immediately, mostly from the people not in the actual study. The 2nd group sensationalized it with little to no accuracy. They were also understandably outraged when it came time for them to go home with half empty pockets, so much time wasted especially being the second check in. Such much yelling and cussing that day lol.
I really felt bad for the deceased girl because it was surreal seeing her and hearing her on the phone laughing and talking. She was super soft spoken and chill.
Worldwide is the shittiest place and this did not bring comfort by any means, but I won't credit this unfortunate event with them.
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Location: Florida I mainly do: Healthy Studies # of studies I have done: 3 A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has opened up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
Post by FloridaGirl on Jun 10, 2017 18:09:54 GMT -5
Thanks Wave for passing on the info to what actually happened:) I am assuming that there were outside factors in her death. I have done studies where they keep u in house so they can keep an eye on your activities which is probably a good idea. I am sorry that a young girl lost her life and can understand why they stopped the study. Thanks for sharing accurate information.
Wow, someone died during the washout period, so Worldwide sent all the studies home early? Even the ones who had already dosed?! Sad, seeing how sending someone home early led to Robles's death back in 2007. This entire practice of dosing subjects, and then sending them home because of side effects stinks to high heaven. For those who are unaware, Cedra and Worldwide are basically the same thing. Much of the equipment that Worldwide uses still has the "Property of Cedra" markings on it. They changed their name to Worldwide Clinical Trials a couple years after this disaster. www.sacurrent.com/sanantonio/more-san-antonians-resorting-to-drug-trials-despite-the-risks-they-pose/Content?oid=2242271
Simon- That article is from 2011. Not to discredit your statement but as a lab rat we all take a risk no matter how small. Some people just don't react the same way to medication and that is one of reasons clinical trials are done.
If Worldwide stopped the studies until more information is available we should all be happy that they care more about our safety then completing a study!
Post by amarie8414 on Jul 19, 2017 16:07:31 GMT -5
I was also in this study, I was in the group with the yellow shirts. And technically the study is not over quite yet. Since we didn't check in for the second period due to the unfortunate circumstances, they informed us that they would be doing an investigation to see what exactly went wrong. Apparently the poor girl died six days after taking the medication. But according to them the medicine should have left her system three days after dosing. So now they're trying to see what exactly was the cause of her passing. Once they told us this, they also told us that we had two options: we could stay in the study or drop out. And if we dropped out, we were going to be paid $600 for the 1st period that we already completed. But if we decided to stay in the study, we would recieve the $600 plus an additional $100 each week from anywhere between three to ten weeks (that's how long the investigation would take). So I decided to stay in the study. And that same day that I left WorldWide and headed back to Houston (which is where I live), I received $600 and another $100 two days later. A week went by and I got a call to come back to Worldwide to sign consent forms stating that I agree to stay in the study even though there was a death and also to agree to receive $100 every week while the investigation is underway. And in for me to receive the $100 every week, I would have to agree to a weekly phone call, every Friday, where I would have to answer study restrictions questions which consist of, "are you taking any other medications, have you consumed grapefruit products, are you involved in any other studies" etc etc. Once I answer the questions I receive $100 that afternoon. Or sometimes that Monday of the next week. So this week makes ten weeks and when they called me last Friday they told me they would let me know this week if they will complete the study or just drop it. I feel they should've just stop the study from the start and gave everyone the full amount which was $2000. And the crazy thing is this is my first study EVER with WorldWide.
P.s. I will update you guys Friday afternoon when I have more info.
Post by amarie8414 on Jul 25, 2017 12:25:02 GMT -5
Sorry guys I'm late with the update but WorldWide called me Thursday the 20th so I could answer my study restriction questions, which is what I did, and I received a hundred dollars Friday afternoon. And I was also told that they still haven't heard anymore news from the sponsors but they will call me again this week. But at this point I might just drop out this study and register for another one because this is taking too long.