Thoughts from a Lab Rat

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.

There are many different types of studies. This bit primarily focuses on duration, multi-part and out-patient visits or OPV for short. First off, if you’re looking for a study, you will be given many options. Some studies are one period in-house. Some studies have 2, 3, 4 or more periods that you have to be able to attend. Some studies have OPV’s where you visit the clinic for a few minutes to a few hours. Some studies have in-house stay or stays and one or more OPV’s. It is important to remember that when you sign up for a study, you are agreeing to complete all parts of the study including multi-part periods and OPV’s. Failure to do so can result in reduced payment.

The length of the study and number of in-house stays will depend on what type of trial and the objectives that the sponsor is looking for. In early first in man trials, most trials will be short and comprise of a single dose. As the drug proves its safety and tolerability, longer trials are conducted in which multiple doses are administered. Many of the trials that have multiple periods involve escalating doses, different formulations, comparison of various drugs or bio-equivalency of brand name medications to generic counterparts.

Now for the numbers. Single in-house periods can last from 2 nights to 30 nights for most studies with some studies lasting longer than 30 days. Multiple period studies usually last 2 to 7 nights with 2 to 4 or more periods. There are endless variations and just when you think you’ve heard of everything, some strange study comes out. Anyhoo, there are studies for just about any comfort level. Some people don’t want to spend a long time in the clinic and choose to do the short studies. Students do the weekend studies so they can attend classes during the week. And then there are the people who do studies for “the time being” who usually do the longer studies. The only problem with the long studies is that you are in the clinic for weeks at a time with the same people. Some people don’t do well with this and occasionally drop out. I liken the long studies to attending a nice long summer camp or training camp. There are ups and downs but in the end, you are working towards one goal. Finishing. Getting paid. Helping medical science. I always suggest that new volunteers try a short study to see if they like it or not. It’s not for everyone but whether you do one study or a dozen, you’re helping to bring new drugs to the market.

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There will be a segment on the upcoming edition of World Report on HD Net about clinical research volunteers. Several volunteers and other figures from the industry give the viewer insight into the world of clinical research. If you miss it, there are podcast available on itunes. Dish Network 362, DirecTV 79 or 306. Also available on cable but you must have HD service. Tuesday, November 18th 9:00 PM EST