Thoughts from a Lab Rat

It all starts with the first study. First of all, doing studies is not for everyone. Obviously, people who are squeamish about needles probably should stay away. My biggest recommendation is that you find a short study, less than a week so you can test the waters. By doing a short study, you will be able to see how the process works, how it feels to have 10 to 20 blood draws in a day and how it feels to be secluded from society. If you find that you don’t like how things are going, I do recommend at least finishing the study. A lot of hard work goes into putting a study on and while yes, you do have the right to quit a study at anytime, for any reason, once you have started taking the study drug, the safest thing to do is to finish out the study. If you do ask to be dropped from a study early, the study doctor will typically ask you to stay for at least one night to make sure that the study drugs are not having any adverse side-effects. Again, this is for your safety.

So, what should you expect during your first study? A lot of what happens during the study takes place at the screening. You will usually have ECG’s, vital signs, blood draws and examinations by the study doctor. Depending on the study, there may be additional procedures such has heart monitors, urine collection and position restrictions. All of the study procedures are outlined in the informed consent. Chat with some other people at the screening. Chances are, many of the other people there have done a study or two and can share some of their experiences. It’s usually not as bad as many people think it is. Most people who think being a research subject is dangerous or freaky probably have never done a study before. Of course, the media and film portrayals don’t help. Sure, things do happen but as long as you are truthful while enrolling in a study, you will minimize most risks.

The time between studies can be from 30 days which is ideal to months or longer. The standard washout for most stuides is 30 days while some may have longer washouts like radiolabel drugs which are one year before you can do another radiolabel drug. Most studies count the time since your last dose in a study while other count the last participation date which would normally be an out patient visit. Once you complete a study, you should be on the look out for your next study. Keep in mind that just because you schedule a study doesn’t mean you’ll get into the study. Studies get cancelled, postponed, reworked which may lead to exclusion or things may come up in your own life that prevent you from doing a study. It is important to realize that the money you make from one study may need to last for 6 to 8 weeks or longer as some clinics pay upon the conclusion of the study. If you’re like me, bad with money, you should always be on top of priorities like rent and phone bills. Like I always say, one day you’re scheduled to check into a 5k study and the next day you’re standing in line at Long John Silvers for a free fish taco. Don’t count your chickens until all of the eggs have hatched. Don’t write checks your body can’t cash. Keep on top of things and plan for dry spells. I’m, bad about things like that but that’s life. Peace yo’

Okay, so that’s a bit drastic. But the reality of the situation is that times are tough right now. The prolonged recession is affecting the pharmaceutical industry which in turn affects the research and development which in turn affects the need for volunteers. Will things get better? Yes. This has happened before. The demand for volunteers fluctuates depending on the stages of a particular drug. When drugs first come on the scene, as in first in man, the trials require 6 to 8 subjects per cohort and there are usually 4 to 6 cohorts. As the study progresses, more and more volunteers are required until the study switches over to patient trials which require even more volunteers. Sometimes there are more first in man studies than later stage studies and sometimes it’s the opposite but most times its an even mix.

But it’s so hard right now! I feel all of your pains! Believe me! I live the same life you do. I’m scheduled to check-in to a fantastic study one day and am digging holes in a field for 6 bucks an hour the next. Being a lab rat full time can be rough, I mean rough. With no guarantees of a stipend check, it can be very difficult to plan ahead. Certainly it would be nice if the dedicated volunteers such as us had some more security in our work but with the way the industry works that is not possible.

Things will improve but we have to be patient. There are studies out there. They may not be the highest paying but they all lead towards a better, healthier future for everyone. As I’ve mentioned before, there is risk involved with doing studies. Not only the possibility of uncomfortable side-effects but the reality that nothing is guaranteed as a volunteer. We are all here out of our own freewill and fully understand the risks involved. Sponsors may cancel and postpone studies at the last minute but there is usually a legitimate reason involved. Whether it is restructuring the study because of safety concerns or the FDA steps in, it’s all geared towards keeping clinical research studies as safe as possible. Obviously, there is no way to prevent all problems that come up but that is the whole point of conducting research trials, to make sure that as many side-effects are detected as possible.

So, keep a sharp eye out for studies and don’t panic. While I would recommend being open to other opportunities, don’t count out the future of clinical research.

Free time can be the biggest problem for full-time lab rats. In the US, there is a minimum of 30 days washout (not participating in a clinical trial) between each trial. During this period, many people have part-time or even full-time jobs that allow them to knock-off for the trials. For people like me, I’m not much into working during my off period but I do some piece work when money gets tight. Waiting for your next study can be a job in itself. Keeping an eye out on the websites or calling the clinics every so often can leave little time for other things in life.

I try to get one or two day gigs off craigslist. It can be hit or miss most of the time but I find that I get enough work to keep me happy. I also free-lance as a balloon artist. I know several people involved with network marketing scams (ahem, I mean businesses). I’m not a fan of networking marketing but if it works for you, then more power to you. What you make out of your off time if totally up to you.

Cardinal Rule #5. Compete all parts of the study - Once you sign up to screen for a study, you should be committed to follow through with the study. Once you screen for a study, you should make every effort to check in. It is inappropriate to cancel a study once you’ve screened just because a better study comes out. If a study doesn’t have enough volunteers checking in, it may be postponed or cancelled. How would you feel if a study that you really wanted to do got cancelled because a bunch of people quit at the last minute? Okay then. it’s a two way street. Once you start the study, you should finish all parts including multiple stays, out-patients and follow-up phone calls.

I know several people who have violated this rule and have lived to regret their decision. The most common way people violate this is by jumping to better studies. Let’s say you signed up and screened for a $4,000 study that starts in 3 weeks. Then a $6,000 study comes out so you go screen for that one. This study starts roughly the same time as the first so you cancel the $4,000 study. Then the second clinic calls and informs you that the $6,000 study has been cancelled. Bummer. You cancelled the first study so now you have nothing. I have heard worse stories than that and they all end up the same way. They got greedy and tried to make more money in less time and ended up with nothing. I can’t seem to say it enough, ‘just sign up for a study and follow it through to the end.’ Whether the end be the end of the study or a cancellation. Don’t keep switching studies until you get what you want because studies get cancelled or postponed at an alarming frequency. Unless you have the money to wait six to eight weeks between studies for that big one everyone keeps rumoring about, you’d better just choose the best study available and be happy with something rather than nothing.

Many studies require a baseline as part of a study. In simple terms, a baseline is a period of time and collection of records that is compared to another set of time and records which is normally known as the pharmacology line. Okay, it’s probably not called the pharmacology line but it sounds good. The baseline is usually a period of 24 hours but can be shorter or longer. The only difference between the baseline and the pharmacology line is that the baseline is conducted without the study drug and the pharmacology line is with the study drug. All of the procedures during both periods will be done at exactly the same time. The purpose of obtaining a baseline is to compare the normal function of a study subject to the same subject taking the study drug. This allows investigators to see what changes the study drug does to your body. Normally, a baseline is done before the first dose of the study drug. That means that you may check into a study 1 to 2 days or more before the first dose. Normally, backup subjects are kept during the baseline period as subjects can still be disqualified before the first dosing. The pharmacology line period usually begins with the first dose. When doing a study that has a baseline, it is important that both periods are done exactly the same. If some time points in during one period differ from the other, then the results cannot be deemed valid. So if you do a study with a baseline, make sure you are to your procedures early.

So, you just finished up a study. So now what? Well, many clinics recommend that you take an iron supplement to help replenish your red blood cells and hemoglobin. While your body does need the extra iron, you will be better off eating foods that are naturally high in iron. Natural iron absorbs quicker and more complete than supplements. Foods that are high in iron include red meat, oysters, mussels, clams, shrimp, beans and green leafy vegetables. If you feel you must take a supplement, take an iron-complex supplement rather than iron by itself. The iron-complex comes with additional elements like vitamin C which aid in the absorption of the iron.

Once you complete a study, you should not have unprotected sex for a period of at least 90 days or as outlined in the informed consent. The effects of an experimental study drug are unknown and can be harmful to child conceived while taking the drug. If you have sex during this time, you need to use a double-barrier method of birth control.

All clinics in the US require a minimum 30 day washout period between studies. During this time, you must not participate in another clinical research study. Some drugs will have longer washouts in order to be sure that the drug is completely out of your system and your body allowed enough time return to normal. At most clinics, you can screen for another study during the washout period as long as the study checks in after the required washout period. I recommend waiting at least 2 to 3 weeks after the completion of the previous study before screening for another. Certain clinics, sponsors or study specific guidelines will determine when the washout period begins. Sometimes it is the last dosing date, sometimes the last participation date (check out or out patient visit).

Study Payments

Every clinic has their own policies on how and when they pay your stipends. Every clinic usually outlines their payment information in the informed consent and or house rules. Generally, short studies (less than a week) will be made in one lump payment in the mail. Longer studies (over a week and or multiple stays) may have two or more payments. Again, there is no set standard and each clinic can pay you however and whenever they like. Most clinics will specifically say 7 to 14 business days once the study is complete but most times you will get it sooner.

It is important to note that most clinics operate on a completion payment system. That means that in order to get the full advertised amount, you must complete all parts of the study. This includes all in-patient and out-patient visits. Failure to complete all parts will result in forfeiture of the completion bonus as most clinics call it. Many clinics also fine you if you are late to your procedures or fail to follow all the clinic rules. If you are fined, this can delay your payment.

So it’s best to make sure you follow all the rules, be on time to all of the procedures (that is what they are paying you for after all) and complete all parts of the study.

Every year clinical research is different for each volunteer. While some volunteers have had exceptionally good fortune, some volunteers couldn’t get into a study if the only requirement was to show up. Every study is different for me. Sometimes I have no problems for 3 or 4 studies then all of a sudden it takes 3 or 4 tries to get into one. I often tell people that with all the things clinics test you for; it’s a miracle that everything is ever within range.

I’m well into my fifth year now and will give now give you the “8 Most Compelling Reasons” to participate in a clinical research study.

8. You get 4 weeks off between each study. Try getting that from any employer!

7. You get paid to take drugs! Okay, not the most enjoyable drugs but hey!

6. You don’t have to cook, do the dishes, clean the house or any other chores.

5. While it may be like jail, 3 hots and a cot, you also get a check.

4. Where else can you sit around and watch TV, movies and surf the internet all day and get paid for it?

3. It’s sort of like a mini vacation. You get to see something new, eat different foods and you don’t get stuck with a bill at the end. Unfortunately, you do get stuck with needles throughout.

2. It’s like a social networking website, but in person!

1. Instead of helping a few people, you’re helping millions of people who suffer from all sorts of ailments.

Economic Slowdown

Well, as most are no doubt aware, there is a major economic slowdown in the US and around the world. This has effected nearly every industry and of course the pharmaceutical industry which in turn affects the contract research industry are no different. So, long story short, there are significantly fewer studies available than the same period last year and a larger audience of eager volunteers clamoring for the few slots available. Don’t panic! As the economic climate improves, so will our industry thus increasing the amount of studies available. Hang in there. Sometimes you have to do a smaller study to make ends meet. You won’t always be able to get five k studies. In fact, it’s been a long while since I’ve done one. Anyhoo, don’t forget the ultimate reason why we do studies. To help make the world a better place. People will always need medications so our industry will weather the storm.

There was a story on the CNN website recently about unusual and legal ways to earn extra money and being a lab rat was one of them. It can be a rewarding experience to participate in a research study but the process of getting into and completing a study can be quite lengthy. This site primarily deals with healthy clinics, clinics requiring volunteers with no prior illness or medical conditions and who are in generally good health. For those looking for extra holiday cash, unfortunately, the odds are that few studies will be screening and completed before the holidays. Most clinics have geared down for the holiday season and will start back up in early January. I am glad that so many people are interested in helping medical science; hopefully you all realize it’s more than just a check! So, with that said, if you are interested in doing a study, you can use this site to locate a clinic near you or one you are willing to travel to. You will then need to contact the clinic directly to sign up for a study. This site is not affiliated or ran by any clinics so you cannot sign up for a study through this site or by contacting this site through email. If you have any other questions, do feel free to email and I will get back to you as soon as possible. Thanks again for all the interest in being a volunteer and best of luck for the new year!

There are many different types of studies. This bit primarily focuses on duration, multi-part and out-patient visits or OPV for short. First off, if you’re looking for a study, you will be given many options. Some studies are one period in-house. Some studies have 2, 3, 4 or more periods that you have to be able to attend. Some studies have OPV’s where you visit the clinic for a few minutes to a few hours. Some studies have in-house stay or stays and one or more OPV’s. It is important to remember that when you sign up for a study, you are agreeing to complete all parts of the study including multi-part periods and OPV’s. Failure to do so can result in reduced payment.

The length of the study and number of in-house stays will depend on what type of trial and the objectives that the sponsor is looking for. In early first in man trials, most trials will be short and comprise of a single dose. As the drug proves its safety and tolerability, longer trials are conducted in which multiple doses are administered. Many of the trials that have multiple periods involve escalating doses, different formulations, comparison of various drugs or bio-equivalency of brand name medications to generic counterparts.

Now for the numbers. Single in-house periods can last from 2 nights to 30 nights for most studies with some studies lasting longer than 30 days. Multiple period studies usually last 2 to 7 nights with 2 to 4 or more periods. There are endless variations and just when you think you’ve heard of everything, some strange study comes out. Anyhoo, there are studies for just about any comfort level. Some people don’t want to spend a long time in the clinic and choose to do the short studies. Students do the weekend studies so they can attend classes during the week. And then there are the people who do studies for “the time being” who usually do the longer studies. The only problem with the long studies is that you are in the clinic for weeks at a time with the same people. Some people don’t do well with this and occasionally drop out. I liken the long studies to attending a nice long summer camp or training camp. There are ups and downs but in the end, you are working towards one goal. Finishing. Getting paid. Helping medical science. I always suggest that new volunteers try a short study to see if they like it or not. It’s not for everyone but whether you do one study or a dozen, you’re helping to bring new drugs to the market.

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There will be a segment on the upcoming edition of World Report on HD Net about clinical research volunteers. Several volunteers and other figures from the industry give the viewer insight into the world of clinical research. If you miss it, there are podcast available on itunes. Dish Network 362, DirecTV 79 or 306. Also available on cable but you must have HD service. Tuesday, November 18th 9:00 PM EST

The sponsor is the company that is sponsoring the study. In most cases, the company is a pharmaceutical company. When you participate in a research study, you will take drugs from major companies you’ve heard of and from smaller companies all over the world that you never knew existed. Companies like Bristol-Myers Squibb, GlaxoSmithKline, Merck & Co., Pfizer, Sanofi-Aventis and Schering-Plough all use clinics to test their drugs. There are hundreds of other companies you will see as well. Take a look at the wikipedia entries for the above companies and chances are that you may have done a study involving one of their drugs most likely as a reference product or complying drug. When a clinic conducts a study for a sponsor, there will usually be representatives for the sponsor present for the first does of a study and various points throughout the study. You will occasionally see clinic executives giving tours of the facilities while your in-house to potential sponsors. There is typically no interaction between the sponsors and the volunteer research subjects. The sponsor reps are merely there to see that the study is being carried out according to protocol. While you should always be following the rules of the study and the clinic, it is especially important to do so while sponsors are around as THEY are the ones paying you! If they see that the subjects are not following the protocol of the study, they can stop the study and move it to another research clinic in which case the clinic lose business and in turn reduces the amount of studies available to you. So, to wrap things up, the sponsor is the invisible force behind the study and you should respect the sponsor as they not only pay you but are trying to get new drugs into the market place for benefit of countless people in need.