Thoughts from a Lab Rat

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.

Sorry, I’ve kinda fell behind on the updates on this site lately. Been working on some other projects. Anyhoo, I will try to do my bi-annual update soon.

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!

There is a reporter doing a story about clinical research and he would like to interview someone from the New York City area who does studies for a living. If you are interested, give him an email at jfanelli@nypost.com

http://www.cri-research.net/particip/volunteer.html

Visit the link above for more information

Well, I still don’t know why it keeps crashing, but it’s up for now. I suspect that it’s because alot of spammers try to access the board. Well, it’s up for now.

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.

I forgot how to fix it so I will not have a chance to work on it til the weekend. If anyone knows anything about the phpbb, please email me!
reply@jalr.org