Archive for August, 2007

Washouts

Sunday, August 26th, 2007

Doing studies can be a great source of income and some people like to do as many studies as they possibly can. Every clinic has a designated ‘washout’ period in which you are not allowed to do studies. The standard is 30 days from the last dose unless otherwise specified in the informed consent. Some types of drugs may require longer washouts. In the US, there is no universal monitoring system in place due to the confidentiality of each clinic. Therefore, it is up to you to ‘police’ yourself and make sure you are obeying your washouts. There may be consequences from doing studies back to back. Drug interaction of course, is the main concern. Also, your blood supply needs replenishing and your veins need time to heal. Just Another Lab Rat! highly recommends that if you are one of those who does studies back to back without obeying the 30 washout period, that you stop doing so. You may never get caught but you may be skewing the results of subsequent studies by not having a clinically clean bill of health. Again, I cannot stress this enough, clinics and sponsors are paying you to use your clean body and for you to follow all study parameters. It’s just like buying a car from someone who knows that there is a problem with the transmission but they fail to tell you. I’m sure you would like the honest truth from the car seller. So does the clinics and the sponsors but ultimately, the people who will eventually benefit from the drug.

Your Responsibilities

Sunday, August 19th, 2007

We as human test subjects have an awesome responsibility. Out sole task while participating in a clinical research study is to provide the sponsor (drug company) with accurate and valid results for their study. What this means is that we have to do a number of things to help ensure the integrity of the study. First off, honesty during the screening process. You should always disclose any medical conditions you have and any otc or prescription drugs you have taken recently. You should obey all washouts. Once you are in the clinic, you should obey all the rules of the clinic. You must report to your procedures on time. Being late can skew the results of the study. After all, the sponsor is paying for accurate results. You should report all adverse events to the proper staff, usually the paramedics. Once you are finished with the study, you should obey post study washouts such as not participating in another study for a minimum of 30 days. By fulfilling your responsibilities, you will help ensure the study results are clean, accurate and timely results.

Being a backup

Sunday, August 12th, 2007

Nobody wants to be a backup but somebody has to be one. Every study is going to bring in a few extra subjects as backups in case one or more of the primary subjects fails to show up or pass the check-in procedures. Sometimes no backups are used and sometimes all of the backups are used. You never know. Some sponsors will not run their study unless they have a full panel, so having enough backups is a must. Even if you are a backup and don’t get used, you will usually get some money for your troubles and priority preference for your next study. Who knows, it could be a blessing in disguise and you get into a much higher paying study.

Reporting Adverse Events

Sunday, August 5th, 2007

The most important aspect of participating in a clinical research study is to record the side-effects of a drug. You see the commercials all the time and somewhere they always have the known side-effects. That information comes from us. Clinical research volunteers. It is up to us to make sure that we are reporting all of our side-effects and that we are only reporting side-effects that we actually have.