Thoughts from a Lab Rat

Spaulding Clinical, located about 40 miles north of Milwaukee, has been open now for about a year. While only one study has been completed thus far, the current study cohorts comprises of around 240 volunteers. As with any new business, it takes time to develop a client base. As studies are completed and Spaulding’s reputation increases, so should the amount of studies available to potential volunteers.
The facility offers volunteers the comforts of home while on the road. Each room accommodates two volunteers with private televisions and ample room to store personal belongings. The common areas are open and bright with ample seating areas. The facility encompasses the modern commercial requirements while still providing a homely atmosphere. Other than the lack of studies, volunteers have had little to complain about.
If you live in Wisconsin or Illinois, give Spaulding Clinical a try. Be sure to tell them you heard about them from Just Another Lab Rat!
(800) 597-4507
525 S. Silverbrook
West Bend, WI 53095

I know many people do it. What am I talking about? Plan B. It’s tough to get into a study sometimes and with the possibility of cancellations, postponements and just not getting into a study, it only seems right to have a backup plan. While it may seem like good intentions, it can backfire.
Let’s say that you signed up to screen for Study A on the 1st and it checks in on the 14th. You then sign up for Study B which screens on the 3rd and checks in on the 18th. So, if for whatever reason you don’t get into Study A, then you could still get into Study B. Sounds simple, right? Wrong! So let’s assume that you pass the screening for both studies so you check into Study A. You make it in. So when Study B calls to confirm check in, you of course have to decline. While yes, you can withdraw your consent at anytime, a clinic may penalize you on future studies. Some clinics will temporarily ban you from doing studies while others will do nothing. It’s not so bad when you cancel a study before the screening as the clinic hasn’t spent but a few dollars but if you cancel once you have screened, the clinic has spent on average $450 to screen you. This is of course part of running a study but if the clinic has too many qualified people canceling at the last minute, then it eats into the bottom line and of course clinics are businesses (there to make money) so they will make adjustments to their policies to curve the problems. Furthermore, if too many people cancel out of a study and the clinic can’t screen enough people to replace those in time; the study can be postponed or cancelled. So the problems you’re trying to avoid can lead to the same problems for your fellow volunteers.
Okay, so is it bad to have a backup? Yes and no. If you cancel a study for a legitimate reason such as a death in the family, family emergency, then no, that’s life. But if you have a pattern of constantly signing up and canceling studies, then clinics are going to notice and may crack down.

Going through my own issues right now. Just another reminder about the inherent instability that comes with volunteering or at least trying to volunteer full-time. Studies come and go. Money comes and go. It can take 3 days or 3 months to get into a study. The clinics and sponsors are emotionless entities that can’t care about your personal life other than what directly affects the study. They don’t care if your rent is due or your car is being repoed. Anyhoo, being a lab rat is just like being the real animal. Life is full of uncertainties.

What is a Clinical Research Organization? A Clinical Research Organization also known as Contract Research Organization, supports the Pharmaceutical industry in many ways with the primary objective of conducting clinical research trials. There are thousands of sites across the US. They can be as small as sole practitioner or as large as a hospital. The major clinics that I profile on my site only make up a small percentage of the total sites as the majority of the sites are the small sites that do condition specific trials (patient studies). IE, a weight-loss doctor would only conduct weight-loss studies, a diabetes clinic would only conduct diabetes studies and so on. The major clinics, more commonly known as Phase I clinics conducts studies covering nearly all conditions. In fact, what the medication is for is usually a mute point as Phase I trials gather the pharmacology information rather than to see if the drug actually works for its intended purpose.

Every CRO is slightly different, in the way they manage the trials. It is a competitive industry and CRO’s with marginal results will be passed up for CRO’s with the best track records. What kind of results are the CRO’s trying to get? The most accurate results. This primarily focus on having all the data collected uniformly and accurately. It is widely assumed that the CRO’s decide how to carry out the studies. This is false. The sponsor (drug company) comes to the CRO with their requirements of the study and the CRO conducts the study as requested.

The bottom line is that CRO’s are businesses, not charities. They are here to make money, not give it away. The money they pay you is a stipend for services rendered. Operating a clinic is not as simple as it seems. It takes a large amount of preparation to run a study. It is also very expensive. It costs on average $450 to screen a potential research subject. And that is regardless of whether the subject is accepted into the study. For the CRO’s, it is imperative that the studies are carried out correctly. And you should be equally invested in that goal. If a sponsor gets poor results from a CRO, it will choose a different CRO in the future which in turn will reduce your study opportunities. So be appreciative of the chance you have to not only help medical science but to also earn a little extra change in the process.

Every clinic is like a restaurant. Some people adore Mc Donald’s while some people avoid it like the plague. I don’t think there is one restaurant in the world that everyone would equally like.

There are many different clinic environments. Some clinics have that industrial look and feel, like cruising down a Miami industrial area with the theme music from Miami Vice blaring. White buildings with lots of steel and black smoke glass. The interiors with bright colors and minimal furnishings. Yeah, you know the look. Other clinics tend to have a more homely feel with couches, recliners, pictures and flowers everywhere.

I find that the smaller clinics tend to be more laid back as there are fewer subjects. The larger clinics must run with more of an iron fist in order to maintain order and keep all of the subjects in line. It’s not that clinics are trying to be mean to the volunteers.

With any job, there must be rules to be followed in order to ensure that the objectives are being met. In the case of clinical research, each clinic can set their rules to what they believe will get the best results for the study. Certainly we are all adults and can take care of ourselves but anytime you put a bunch of strangers in close quarters, there’s bound to be compatibility issues with each other. The clinic’s main role is to conduct the study and get valid results.

So not everyone is going to like every rule. But again, and I can’t seem to stress this enough, everyone is there voluntarily. You may leave the study at any time, though you will get paid less. It is up to each volunteer to be responsible for him or herself.

So long story short, there are clinics I personally like and some that I’m not fond of. But all clinics are working towards the same goals; conducting clinical research studies in the safest and efficient manner to get new drugs to the market or at the very least, discover what compounds work and do not.

It seems silly that I have to keep writing about this but my thoughts of the week come from my own experiences and those of my close friends. It seems more and more people feel they don’t have to follow simple rules. They feel like the clinics are treating them like children. Why would people feel like this? Because they are required to do stuff during the study? They are required to be at their procedures before the procedure starts? They are required to follow the rules of the clinic? They are required to do things they feel they shouldn’t have to do? Why? Because that is part of the study.

When you sign an informed consent form and house rules form, you are agreeing to follow the rules of the clinic, to complete all of the required procedures and to be on time. Why is time so important? Because the sponsors (drug companies) of the studies are paying millions of dollars to research and develop new medications to help your family and friends to have better pain medications, shorter flu symptoms, an erection when the time is right and treatments for thousands of other ailments.

Studies are conducted to see how the drug affects different people but in order for a study to be conclusive, every subject must complete the study in the same way ie eat the same foods, blood collected at the same times etc. It may not seem like a big deal to you but when a sponsor has to pull a study because the data is useless, it just means that the clinic you are going to will lose a client and that will equate to less studies in the future. It all goes around.

Many of the clinics I go to ban cameras including camera phones yet people still sneak them in and get upset when they are discovered. They argue that they weren’t going to use the camera. Well, if you sneak a gun on a plane but you weren’t going to hijack the plane, does that make it okay? No! Rules are rules! Rules are created in response to problems in the past to prevent problems in the future.

The vast majority of the volunteers DO follow the rules and make the effort to complete their studies properly. It’s just a few bad apples that spoil it for everyone else. So do yourself a favor, realize that doing a study is a serious responsibly and can have serious consequences both seen and unseen for those who choose not to follow the rules.

Some chide the clinic for being old and cramped. Other lauds the clinic for its attentive staff. I find the clinic to be a welcome relief from the big box clinics where everyone is pushed through number by number. The ACPRU has a maximum capacity of 36 but routinely runs 2/3 full. There are only dozens of staff members as opposed to hundreds. During the time you are at the clinic, you get to know the staff and they get to know you. While the dorm rooms may be sparse, a bed with a headboard cubicle shelf, maybe a bathroom, maybe a desk, maybe a humidifier or fan and a view of the parking lot or the surrounding neighborhood, they provide a quiet place to read or rest. Back to the humidifier, the unit is very dry and your skin will feel it after a few days. The humidifier helps a little. The meals are prepared by the hospital, Vista Medical Center East. Every now and again the hospital volunteers host a bingo session played on the TV’s. Play for glamorous prizes against everyone staying in Abbott and everyone else in the hospital. Truly a memorable experience. The clinic uses an electronic logging system which I feel every clinic should use. Every procedure whether it’s a meal, blood draw or vitals is logged using a bar code on a badge you wear around your neck. This provides accurate logging of procedures to the second. You are allowed to have visitors during the day but you and your visitors must stay in the lobby. Visitation is rare nowadays so it’s a nice perk. There is a computer room with a few public computers. Wifi access is only available on the east wing or the area around the computer room. There is a TV with Playstation 2 in a hallway closet. There are 3 satellite TV’s and plenty of videos and board games. All in all, the ACPRU is a pleasant place to spend a few days or longer while helping to further medical science.

In the end, it’s all about the money.

That of course is NOT how I see things and why I have provided this site as a resource for free since its inception in 2004.

I believe that the internet should be a place for everyone to freely exchange ideas and information. Quite frankly, if you don’t want the world to know something, don’t put it on the front page of your website. With that said, it is important to point out that each clinic profile page on my site has been put together using freely available public information and that the embedded web pages primarily showing current studies for a clinic are merely linking to the clinic page which again, is freely available to the public. With the exception of a handful of clinics, I do not receive study information from the clinics.

My site was designed to streamline the process of locating studies and to provide potential volunteers with insight and reminders of what clinical research is all about. This site promotes ethical and responsible behavior by research volunteers as well as serving as a benchmarking tool for clinics to help improve the experience they provide to volunteers. This site will always be free and due to being hosted as an organization website (.org) will always be advertisement free with the exception of raising monetary support via t-shirt sales to help offset webhosting costs.

Clinics can ban volunteers from participating in studies for a variety of reasons. Probably the most common reasons include blood pressure, hot drug/alcohol tests and out-of-range blood labs. Other reasons may include failing to follow the rules of the clinic which can include sneaking in contraband, fighting, vandalism, not calling to cancel screenings and much more. So, if you get banned from a clinic, depending on what you got banned for, you may be able to get the decision reversed.

Drugs and Alcohol - Most clinics have a zero tolerance for positive drug and or alcohol results. If a positive screening comes up, most clinics will send your sample to an outside lab for confirmation. It the outside lab confirms the results, you will probably be banned forever. And forever is a long time!

Blood Pressure, ECG’s, urine and blood - Every study will have an acceptable range for the blood pressure and ECG results. If your results are out of that range, you will be disqualified for that study. If your results are abnormal (more than a little out of range), the study doctor may impose a temporary ban and recommend that you see your own physician and have the tests redone and if they are back in the range that the clinic is looking for, then you may be reinstated. Some exceptions may be made for ECG’s. If the results may indicate irregular heartbeat, heart murmur or other heart conditions, you may be banned permanently as these results may indicate serious heart conditions. It would be recommended that you follow up with your own physician. It is of course possible that the results at the clinic were just abnormal due to stress, nervousness and you are in fact perfectly healthy and your physician will not find any problems. You can try to forward those results to the clinic for reconsideration.

Hepatitis and HIV - Most studies will require these test and if they are positive, you will be banned from the clinic. Positive tests in most cities may also be forward to the health department. If you are informed of a positive result, you should definitely follow up with your own physician.

There are many other reasons that a clinic may ban you and it’s never an issue until it happens. If you are banned, most clinics have a person or department in charge of volunteer relations who can give you information on whether or not you can get reinstated and what information you must provide.

Don’t take everything a clinic tells you as fact. You should always follow up with you own physician. Many people do get banned from clinics but at the same time, they may find out about health conditions they did not know they had and can thus get treatment for it.

I have heard this question many times this year and have often wondered that myself. In general, studies run in cycles. If you were to take one study drug and follow it through it’s lifecycle which may last one or two studies or all the way to market and beyond which could include dozens of studies, it can take ten years or longer to complete the minimum required studies. With that said, some sponsors may choose to run most of the studies at one CRO which in turn can limit the amount of other studies a clinic can run simultaneously. You also have to consider the size of a clinic. The smaller the clinic, the fewer large subject studies can be ran at one time. Whereas a large clinic can run many large studies at one time. Finally, the process of preparing a study to be ran can be lengthy, especially multiple cohorts since each group of subjects will be analyzed before the next group to see if there are any concerning trends. So, just because a clinic or many clinics seem to have fewer studies than normal does not indicate problems with the industry or with the clinic. It is also important to note that there will naturally be slowdowns throughout the year such as around holidays and towards the end of the summer when a large portion of the subject population returns to college. So, don’t worry. Studies come and go. You just have to catch them at the right time.