Thoughts from a Lab Rat

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.

While it’s still early, there are signs that the economy is on the way to recovery. I’ve noticed that there are more studies at many clinics right now than six months ago. Of course, the holiday period is normally a slow time with closures which limits the duration of most studies. Once we get into January, I think things will steadily improve. Just make sure you stay healthy, wash your hands often and if you come down with the flu, STAY HOME!

While there is no way to guarantee that you will get into a study, there are a few things that may help. Sign up for the earliest screening possible. Make sure you arrive on time to all screening and check-in visits. Be sure to follow all clinic and study specific guidelines. This should prevent erroneous lab results. In the end, don’t worry if you are a backup. I’ve seen studies where all of the backups have been used. But then there are studies where none of them are used. Unfortunately, not getting picked for a study is just part of the game. You can’t let that get you down.

I think I’ve touched on this topic a few times but I’m too lazy to research the last time. As if it’s that difficult to look it up. Anyhow, I’ve got a few people asking about it.
What is a washout?
It’s a period of time where one does not do something. In this case, it’s a period of time where you don’t do another clinical research study. Each clinic operates in a slightly different manner but for the most part, you must wait a minimum of 30 days between investigational drug studies. More specifically, it depends on the type of study you have done and the next study you plan on doing. Most drugs carry a 30 day washout. Certain studies such as radiolabel studies carry a one year washout before you can do another radiolabel study but usually a 30 day washout for a non-radiolabel study.
When does the washout period begin?
Well, each clinic and sponsor will decide. There are two possible scenarios. It may go based on the last dosing of the drug or it may go based on the last participation date of the study which means out-patient and or phone call. Again, this depends on the clinic and or sponsor of the next study you participate in.
Who is responsible for enforcing washouts?
Why that would be you! I recommend keeping a log of the studies you participate in, the dates and the drugs involved. It’s good information to have in order to make sure you don’t violate the washout rules and to make sure you don’t do the same study twice. Most sponsors do not allow participants to do the same study drug more than once. While they will eventually figure it out, it’s better to avoid it all together when you are researching studies to participate in.

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.

I received this question anonymously from a fellow lab rat.

Q. What’s the big deal with grapefruit juice?

A. Nearly every study has a grapefruit product restriction. Why? Because it can interact with numerous medications and can be fatal.

Grapefruit juice, and grapefruit in general, is a potent inhibitor of the intestinal cytochrome P450 enzyme CYP3A4, which can impact the metabolism of a variety of drugs, increasing their bioavailability when administered orally. In some cases, this can lead to a fatal interaction with drugs like astemizole or terfenadine. The effect of grapefruit juice with regard to drug absorption was originally discovered in 1989. However, the effect became well-publicized after being responsible for a number of deaths due to overdosing on medication. However, the first published report on grapefruit drug interactions was in 1991 in the Lancet (British) entitled “Interactions of Citrus Juices with Felodipine and Nifedipine.” and was the first reported food-drug interaction clinically. (wikipedia)

There are many urban legends that have led people to believe that grapefruit juice is the “cleanse all” miracle cure. Smoke a joint before a drug test and swig a few glasses of grapefruit juice and you’ll piss cleaner than the day you were born. While I’m not here to confirm or deny whether or not that works, let’s just say it doesn’t. Sadly, it can have devastating consequences. Long story short, grapefruit juice prevents drugs from metabolizing correctly which means that the medication stays in the body longer than intended. In multiple doses, the medication will stockpile in the liver and can eventually lead to a drug overdose. Certainly there are many factors but in the end, clinics must eliminate as many factors that can effect a trial as possible. This is one major factor that you do not want to ignore.

Email me at reply@jalr.org if you have any questions you’d like answered and I may post them!

Was without my laptop for a few weeks so I haven’t had a chance to update the site. I’ll get to it next week. I have been told by multiple sources that Cedra in Austin has shut down and shifted all clinic operations to its San Antonio location. There is not any confirmation on the website and I keep forgetting to ask when I call for studies. Also, AAIPharma has apparently shuttered its clinic operations but the parent company still exists, so who knows what the future of the company will be. There are a few other minor changes.