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Jeff's Healthy Volunteer Clinical Trial Blog

March 23rd

Hi everybody, I'm Jeff, ClinicalConnection asked me to blog about the clinical trial that I'm about to participate in so here I am. I'm not really sure what information would be most useful to you all so I'll just give you a little background about myself first. I'm currently working as a librarian and have the weekends off so I have been participating in some clinical trials on some of my free weekends. I'm a very healthy guy so the only trials that I am eligible for are the healthy patient studies in which I'll be taking a drug that hasn't yet been approved by the FDA and hasn't been tested in humans before. I know what you're thinking... you're crazy! but I assure you I am not! I have participated in 3 healthy patients studies in the past and have been very happy with the experience. Of course there is a chance that I will have some kind of bad side effect from the medicines I take in the clinical trials but the chances of this are pretty low since the drugs have been tested by researchers in labs. Also, the clinic staff is constantly here monitoring us and making sure that we are well taken care of, so I'm not too worried. Obviously participating in these trials is not for everyone, but I'm more than willing to try these medicines since I get paid for it, it's a second source of income for me.

This trial is scheduled a lot like the previous ones that I was in. I will go in next weekend on Friday night and spend the night at the clinic. I will get the "study drug" on Saturday morning and then I'll have about 20 blood draws over the course of the next 2 days and have my vitals checked every few hours. I get to go home on Sunday afternoon and then I'll come back for a follow-up blood draw on Monday morning and Tuesday morning. I'll then have a weekend off and will go back in for the same schedule the weekend after. Everything should go smoothly, I'm pretty excited about it I guess, I'm going to be watching some movies and wasting a lot of time on the internet! I'll try to blog about it on here as much as possible, maybe I'll even snap a picture or two!

March 28th

As expected, I came to the clinic on last night (Friday) and checked in with the staff for the weekend. They asked me a few questions about whether I’d had any caffeine (I hadn’t, not supposed to have caffeine 24 hours before the study starts), whether I had done any drugs (nope), and whether I had smoked (didn’t do that either – I’m a non-smoker). I then went into the main dorm area and got settled in for the weekend. There are 19 other people that are here for the weekend doing the same healthy volunteer study. One half of the group (10 of us) gets the experimental drug one weekend while the other group gets the placebo, then next weekend the two groups switch so that everyone has had the “study drug” as well as the placebo at some point. We never know when you are getting which (study drug vs placebo) to make sure that people don’t start to report feeling strange just because they know they have the study drug. Anyway, all 20 of us had dinner in the dining room at about 7 (fried chicken and what they said were mashed potatoes) and then we just hung out in the TV room until bedtime (11PM). We had our vitals taken and I read in bed before drifting off.

Saturday mornings are the most hectic time of the weekend. We all woke up this morning at 6:30 and had our vitals taken as well as a pre-drug blood draw, the first of many today. The way the study works we all have to have our blood drawn at a precise time past the actual taking of the study drug and since there aren’t 20 phlebotomists (the people that draw our blood) here we each have to be staggered at everything throughout the day. We each got breakfast one at a time, but only staggered by a minute, so I got my breakfast at 7:03 (I was the third one) and now I’ll always be number three in line to have my vitals taken and blood drawn. The breakfast wasn’t very good, they say you have to have a high-fat breakfast to model the breakfast most people eat but I’m just not used to it, usually I just have a cup of coffee for breakfast, oh well.

After breakfast I went to the doctor’s room and took the study drug (at exactly 7:33), it was a chalky white pill, looked just like any other pill. After swallowing the pill I had 30 minutes before my first blood draw so I went and talked to Davie, a guy that I met on a previous study at this clinic, for a few minutes as he was waiting near the doc’s office (he is number 8). Then it was off to my blood draw at 30 minutes after taking the drug (at 8:03). I’ve gotten really used to the blood draws so I just talked to the phlebotomist while he drew my blood. There are two phlebotomists here for the day, one takes blood from anyone that is an even number and the other one takes the odds. They have a 1-minute window in which to draw the blood so they have to be really good at their job, and they are! Ken, the phlebotomist that drew my blood, works here a lot and is one of my favorites, so I was glad to see him taking care of us odds.

I had my vitals checked again (by the way, vitals are my blood pressure, temperature, and pulse rate) and then I had another blood draw at 1 hour post drug so I just hung out in the blood draw room until it was my turn again. This one was as painless as the last one and now I had a solid hour before my next draw (at 2 hours post drug) so I grabbed my toiletries and took a shower.

Basically, I’ve just been hanging out for the rest of the day, browsing the internet and playing some video games. I don’t feel any different than usual and no effects from the study drug, which is good I guess. I’ve actually never had any side effects from the study drugs that I’ve taken while participating in clinical trials and I don’t know of anyone that has had any ill side effects at all. The worst thing that I’ve ever heard of is someone in my last study feeling “woozy” or lightheaded but I never felt that way.

Lunch was served about an hour ago and now I’m just trying to finish my tax return while I wait for another blood draw (6 hours post drug, at 1:33PM). I’m hoping to get a lot of my work done this evening so that when I go home tomorrow afternoon I can just relax for the rest of my Sunday evening. I’ll try to write another blog entry tonight or tomorrow morning, although my writing seems so boring :(

Question emailed from Sam K. - You said the blood draws don't hurt but with having blood drawn that many times does your arm get sore and do you develop a bruise, and do they draw from both arms or just one?

Answer from Jeff R. - My arm gets a little sore by the end of the weekend (I think there are 15 blood draws in total this weekend) but I don't develop any bruises or anything. I have really good veins, which helps a lot cause you don't want the phlebotomists hunting around for small veins! They will draw the blood from whichever arm you want, as long as the vein looks good for the draw, and they can frequently use the same exact spot.

March 29th

The rest of yesterday passed by pretty quickly, I spent a lot of time talking to Victor who has participated in over 30 clinical trials, I couldn't believe it. He retired from working just over 4 years ago and participates in clinical trials on a regular basis to deal with the boredom of retirement, that seems so strange to me. He is 68 years old but still can participate in many of the trials but mentioned that he cannot participate in some healthy volunteer studies because of age requirements. One on study he had to stay in the clinic for 21 days, he really seems to like the whole clinical trials experience.

I headed to bed early last night since we had to be up at 7 for vitals and a blood draw. After breakfast I just watched TV and waited for my final two blood draws. It's now just past noon and I will have one final blood draw at 1:33PM and then I will go home for the rest of the day. I'm supposed to avoid caffeine for the rest of the day and on Monday and Tuesday since I'll be coming in for blood draws on Monday and Tuesday morning. Then I'll have a weekend off and come back in on the following weekend to do the second half of the study. I don't know whether I got the study drug this time or the placebo, but I felt absolutely no effects, we'll see if I feel anything next time although I doubt it since I haven't felt the effects of any of the drugs that I have taken. I'll write at least one blog entry during my next weekend stay here, hopefully it will be just as easy and relaxing as this one.

April 4th

I was back at the clinic for this weekend and everything went well, except that I was late for one of the blood draws, it was my first time being late for a blood draw and I felt really bad... I missed it because I wanted to take a shower this morning so I got my shower kit together and went to the shower area. Well, I had to wait a few minutes for the guy before me to finish and I guess I didn't take that into account because the next thing I know I hear my name being called. I quickly realized what was happening and rushed out of the shower, but I ended up being 3 minutes late for the draw (8:36AM instead of 8:33) and they had to make a note of that. It's not the end of the world, just a small mistake, but if you are frequently late for blood draws then guess what... they stop inviting you to participate in these studies, so you need to always be aware of the time. Like I said though, it was my first time being late so they won't penalize me for that.

Since I didn't feel any effects of the drug I took last time I was pretty sure that it was a placebo, but now I'm not so sure because I didn't feel any effects this weekend either. I forgot to mention what the study drug is supposed to do... it's supposed to improve memory function in people with Alzheimer's, but I really don't feel any difference which is probably because I don't have Alzheimer's, although my wife does tell me that I have a "selective" memory :). I want to have my wife come to do some of these clinical trials with me but with her job as a nurse it's hard for her to have the entire weekend off, hopefully we can work things out somehow in the near future. There are two couples that are here doing this trial together, not the most romantic place to spend a weekend together but it would be nice to spend the time together.

April 5th

I left the clinic this afternoon and am glad to be back home. I'll keep doing these trials as long as they keep inviting me back, although now I have to wait at least 28 days before participating in another trial to allow any remaining study drug to leave my system, that's called the "wash out period." I have a few friends that really want to get into the trials as well so I'm hoping that they get invited to one of the trials that I'll be doing, it's always more fun if you have good friends with you at the clinic. I hope you were able to follow along with my blog, I know I'm not a great writer and probably left a ton of things out so if you have any questions please let me know, I think the website lets you submit a question to me somehow. Till next time....

Question emailed from Anton J. - How much do you get paid for participating in a study like this? Does the clinical staff treat you well?

Answer from Jeff R. - Well, for this study I was paid $850 for participating in both weekends, or $425 per weekend, that's about the same as the previous two that I was in as well. I haven't been in any trials other than these weekend ones so I don't know how much you would get for longer-term stays or anything like that. The staff here at the clinic treated me extremely well! They were all so friendly and helpful, I think that they treat us well so that we treat them well, that makes for the best work environment possible for them. Sheila, one of the phlebotomists, always greets me with a big smile when she sees me, she rocks! She asks about my work and my wife, she's so nice. The only staff member that can be a bit irritable is Arnold, he is the one that organizes and oversees these weekend trials and sometimes he gets frustrated if people aren't showing up for everything on time, but I guess I can't blame him since he is responsible for everything flowing smoothly.



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