Thoughts from a Lab Rat

There’s a lot of misconception amongst the lab rat population about whether a clinic can call another clinic and confirm if someone has done a study within a certain timeframe. Well, the answer is yes. In accordance with the FDA and the protocol of each and every study, the clinic is required to make sure that you meet all study requirements. One of the major requirements is that you have not participated in a research study in the last 30 days and that you do not participate in more than one study at a time. Doing more than one study at a time or two studies within 30 days can greatly increase your chances of having side-effects including life-threatening conditions. Unless you’re a doctor, you don’t know what will happen if you combine multiple drugs. It’s even more dangerous when you take experimental drugs with the side-effects not even known yet! That is why the FDA, sponsors and clinical research organizations are concerned about washout periods and ensuring that participants are only doing one study at a time.

There have been increasing instances over the past year where volunteers have been “busted” for not obeying the washout period and for doing more than one study at a time. The consequences of getting caught are severe. You will most likely be banned for life from BOTH clinics. Is making some extra cash now worth not being able to do anymore studies? Think about that next time you are tempted to breaking these rules. These rules are in place for your safety as well as the integrity of the study results.

I know I make it sound like you can do studies full time, which you technically can, that doesn’t necessarily mean you’ll be compensated to your satisfaction. Every year is different and the amount of money you may make is going to vary. Under normal circumstances, it is fully possible to do 6 to 8 studies with the 30 day washout in-between each one. It is important to note that you must be on the ball and getting ready to do your next study right at the 30 day mark but provided you are following the study guidelines, you should have no problems. However, in the end, it all comes down to luck. Sometimes a better study comes out after you check in. Sometimes studies get cancelled. Sometimes you don’t quality. Well, it happens But you have to keep trying.

By following the washout and one study at a time guidelines, not only are you helping to keep you safe, you’re also helping to give lab rats a good name. It’s always just a few bad apples that spoil it for everyone so it’s up to all of us to conduct ourselves professionally and to follow all of the rules of the study and clinic.

I’ve seen it happen several times to several people and heard about it happening to dozens more. Disqualified and or banned from a clinic for testing positive for alcohol or drugs during the check in process. Many studies require partial or full retesting at check in. At the very lest, most studies require a UDS (Urine Drug Screen) at check in.

I know it can be tempting to “go out for a good time” or “one last hurrah” before checking into a long study. Just don’t do it the night before! A lot of people think that all they need is 8 to 12 hours to clean out but that is for a small amount of alcohol and there may still be trace amounts and depending on how sensitive the testing equipment the clinic is using, can still detect trace amounts. And for more enjoyable drinkers, it can take up to 24 hours to eliminate all traces. Most clinics require a 48 hour cut off for alcoholic beverages and that is to be 100% sure that there is no alcohol in your system.

If you can afford to lose $3000 for a night out, then by all means, go ahead. But for most people, it’s just wise to wait till after the study and all study restrictions have been lifted to go out and have a good time. You’ll probably find it more enjoyable because there will actually be something to celebrate.

Had an issue with the web host. Things should be back up now. Just a reminder, you can view the entire site minus the blog and forum at www.drugspay.com

Okay, time for a reality check. Certainly, I make volunteering for a clinical research study sound glamorous and fantastic, and it is, when it works. Realistically, one can do about seven to eight studies a year. Ideally, you only want to do the “big” studies all the time but in reality, you usually have to take what is available at the time. Rents, mortgages, car payments and bills all have to be paid in a timely manner and the payments of studies don’t always jive with your payment schedules. What does this mean? You need to budget. Okay, so I’m the absolutely last person who should be talking about a budget, but I just don’t want to see others make the same mistakes that I have made and may still be making.

I have always said that getting into the study is the hardest part. It is. Often times, you have to sign up for a study two to three weeks before the study actually begins. That’s a lot of time for things to go wrong. Studies get postponed, cancelled or you may just not qualify for a study. I know many fellow lab rats that have part time jobs or even full time jobs. It’s important to fill your free time with constructive activities. It is not uncommon to go six to eight weeks without a study check. So it’s wise to always keep an emergency stash in case it takes longer than usual to get into a study. Certain times of the year are slower than others. Mainly around holidays and towards the end and the beginning of the year. Lastly, depending on the area of the country you live in, you may only have one or two choices for clinics. If this is the case, you may not be able to reasonably expect to make a living. You may only be able to do three or four studies. If you’re willing to travel, then you are increasing your odds of doing more studies but at the same time, increasing the chance that you may lose money due to travel expenses if out-of-town studies don’t work out.

Am I suggesting that you don’t do studies for a living? No, but I am suggesting that you use care and budget your money like you may not be getting any more.

http://www.anylabtestnow.com/

Sometimes you may have a lab result that is out of range during a screening or check-in which may exclude you from a study. How do you know when it’s back in range? Clinics usually recommend seeing your doctor and bringing a copy of results that are within the range that the clinic is looking for. But many subjects don’t have healthcare insurance (not even going there) or “family doctors”. So where are those to get repeat tests done? There’s a chain of testing centers that allow walk-in lab tests. It’s called Any Lab Test Now. There are locations in many states and cities with major Phase I clinics.

Most simple tests and panels are $49 with more complex and comprehensive tests costing more. You don’t need an appointment or a doctor’s referral which makes this a convenient and cost-effective way to get your own lab tests. You will get your results for most tests within 48 hours. While these centers do allow anyone to get any test done, they do not provide medical advice or consultations. So if you do have any questions or concerns about your lab results, then it may be best to see a doctor. But for many lab rats that are proactive with their personal health, Any Lab Test Now can be an invaluable tool.

Backup. The very utterance of this term brings shivers to longtime labrats. Nobody wants to be a backup but it’s one of those necessary evils. Truth be told, EVERYONE is a backup until the first dose. Certainly, some check-ins are easier than others. For the most part, clinics will bring in several backups in addition to the number of subjects needed for the study. The reason for having extras is in the event that not everyone shows up and not everyone qualifies after checking in. Most study protocols call for rechecking of labs at check-in as your laboratory results can change between the screening and the check-in. If your check-in labs are out of range or of great variance from your screening labs, you may be disqualified from the study.

Many subjects ask why they weren’t notified over the phone that they were a backup. Simply put, EVERYONE is a backup before the first dose. Yes, when you check-in, everyone is separated in to a dosing spot and a backup, but that is based on each clinic’s placement policies. The majority of the clinics I know place people based on the order they completed screening. In all fairness, the people who screened earliest typically have priority of those who screened last. Some clinics also give preference to backups of previous studies who were not used. Either way, the final decision comes from the study doctor and the sponsor. Long story short, if people were told that they were a backup before they came, most would not show up.

It is important for the study that everyone shows up. It is possible that a study can be cancelled or postponed if not enough people show up. I have seen studies where no backups were used and I have seen studies where all of the backups were used. You just don’t know. Most times, clinics will try to place backups who were not used into future studies and may give preference (priority/vip cards). No one is guaranteed a dosing spot in a study. It sucks. Believe me I know. It sucks to set aside the time, spend the time and money to screen only to not get in. But these are voluntary positions so nothing is set in stone. The best thing to do is just try again and perhaps you’ll get into a better study. Regardless, medical science cannot advance without the timely completion of clinical research studies. Consider it taking one for the team when you’re a backup.

For those of you who use your cell phones to access the internet, you may know that many sites do not load properly on the smaller screens. I just discovered OperaMini which is available for many phones including Blackberries, Palms and smart phones. You can view a full list of supported devices at the bottom of this post as well as a link to the site.

What makes OperaMini different from built in browsers is that rather than accessing the site directly and then downloading the entire page and then formatting it to the device, OperaMini sends the page to one of its servers where it knows what phone you have and optimzes the page, then downloads a smaller version to your phone which is much faster and can load many more pages than standard browsers.

Using my Blackberry Tour (non-camera edition of course!), I am able to access PPD’s site which I previously was unable to. The current version 4 works great but the 5 beta has a few bugs in it but brings ‘tabbed’ browsing as well as a thumbnail start screen you can place you favorite sites.

It’s not a cure all, but it has definately opened up new avenues for my surfing.
If you haven’t tried it yet, give it a shot!

http://www.opera.com/mini/
Device list

One of the biggest questions or concerns people have about clinical research is the side-effects. Am I concerned about it? Well, of course. When you see a TV commercial for a medication, the narrator will rattle off a mile long list of potential side-effects. It is important to remember that these are all of the side-effects that may have occurred during the clinical trials. It does not mean that everyone had all of the side-effects. Different people tolerate, absorb and have different reactions to drugs. While a certain pain medication will work wonders for most, there are some people who won’t have any effect from it. That said, the entire purpose of conducting clinic research studies is to see what side-effects occur and how effective a drug is.

In order to advance medical science, there is no other way to prove a drug than “the proof is in the pudding” as in doing the research studies. The people who participate in these studies should be commended for their willingness to help medical science. It is also important that the people who do these studies understand the risks involved. While some people would be willing to do almost anything for money, the vast majority see volunteering as a meaningful way to earn some extra money.

Wishing everyone a happy and prosperous 2010!
Paul Clough
Owner of Just Another Lab Rat!

Unicorns are magical. They only appear once in awhile. What is a unicorn? It is the big study that pays a substantial amount of compensation. Occasionally, study protocols require extraordinary requirements like staying in-house for 60 days or making 75 out-patient visits or involve unusual procedures. These studies typically pay more than the studies that make up the bulk of Phase 1 trials. It’s very hard to tell when clinics will get these unicorn studies.

When a sponsor decides to do a study, they submit proposals to several clinics in order to get the most compatible bid which includes reputation, past study results and of course overall cost. I notice that a lot of clinics inform staff about potential studies they have bids on and the staff relay this information to the subjects and then it spreads like wildfire as fact. Unfortunately, not every study a clinic bids on will come to pass. If your eligible to do a study, it’s best that you choose one that starts as soon as possible because most screening processes from screen to check-in can spread over a few weeks. The longer you wait for the unicorn study, the greater the chance that you will miss other doable studies and depending on the time of the year, you may miss out altogether.

While high paying studies are great, all studies are equally important. There are studies out there to suit almost anyone’s schedule. Weekend and multi-stay studies work great for students and traditional M-F workers. Longer studies work great for those looking for an alternate lifestyle than the normal grind. In the end, all the studies allow advances in medical science which allows millions of people to live better, healthier lives.