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http://www.clinicaltrials.gov
This is a great website that few people know about or use. While the information on this site covers every trial in the US, it is raw data and does not include information like study dates and compensation amounts. The site is a great resource for finding out information about a particular study you may have called about before going into a screening. There are several ways to search but I find the easiest way to search is to hit the “search for clinical trials” link and in the search box, type in the basic name of the clinic and the city. Example, PPD Austin or Cedra San Antonio. You will get a list of recent studies at the clinic which are currently recruiting, not yet recruiting, completed and so on. The basic study protocol information is available as well as the study locations, expected enrollment, inclusions, exclusions and more. Again, this site should be used for gathering information rather than a method locating actual enrolling studies. This is only a database and the actual recruiting is done by the clinic hosting the study.
Repeats are routine but what are they and how do they work? Well, a repeat is called by the study doctor when a lab value, ECG, blood-pressure or other screening factor is outside of the protocol range. Each study has a range that every lab result must be within. Depending on how out of range the result is will determine whether a repeat will be allowed. Typically, things like blood pressure, body temperature and pulse rate will have an automatic repeat and depending on the study, may allow a manual repeat by a paramedic. Values related to drugs, cotinine and alcohol are not repeated and typically will result in automatic disqualification. For street drugs and sometimes alcohol, you may be banned from the clinic permanently. For most urine and blood values, if your results are slightly out of range, you will typically be called in for a repeat. If the study doctor feels that your results are “clinically significant” or abnormally out of range, you may not get a repeat and will be disqualified from the study. Sometimes the study doctor will refer you to your own physician for a follow-up before you are allowed to screen again.
A repeat can happen at any stage of the study. You can have a repeat from your screening, check-in, anytime during the study, your exit labs and or any outpatient visits. It is important to note that if you have a repeat for your screening, you are not considered screened until you complete the repeat. If you are finishing a study and have a repeat, you are not considered finished with the study until you complete the repeat. Any delays in doing a repeat can affect your inclusion into a study and your payment after a study. If you are asked for a repeat, you should try to get it done as fast as possible.
The reason repeats are done is to ensure your safety before, during and after a study. The study doctor wants to make sure that your screening labs are all within normal or sponsor required ranges to see if there are any changes once you start dosing in the study. Comparisons are done throughout the study to detect any problems. It’s best to think of repeats as being “better safe than sorry”.
The time between studies can be from 30 days which is ideal to months or longer. The standard washout for most stuides is 30 days while some may have longer washouts like radiolabel drugs which are one year before you can do another radiolabel drug. Most studies count the time since your last dose in a study while other count the last participation date which would normally be an out patient visit. Once you complete a study, you should be on the look out for your next study. Keep in mind that just because you schedule a study doesn’t mean you’ll get into the study. Studies get cancelled, postponed, reworked which may lead to exclusion or things may come up in your own life that prevent you from doing a study. It is important to realize that the money you make from one study may need to last for 6 to 8 weeks or longer as some clinics pay upon the conclusion of the study. If you’re like me, bad with money, you should always be on top of priorities like rent and phone bills. Like I always say, one day you’re scheduled to check into a 5k study and the next day you’re standing in line at Long John Silvers for a free fish taco. Don’t count your chickens until all of the eggs have hatched. Don’t write checks your body can’t cash. Keep on top of things and plan for dry spells. I’m, bad about things like that but that’s life. Peace yo’
Many studies require the use of cardiac monitoring. There are two methods. Live and recorded. Holter monitors are used for recording. It’s basically an always running ECG. It is connected with 8 leads to pads on your chest. The recorder itself is about the size of a personal cassette player. Holter monitors are usually worn for a period of 24 hours at a time and depending on the study, you may have to wear it 2 or more days in a row. While wearing a holter or telemetry monitor, you cannot do any rigorous activities or take a shower. Holter monitors record your information to a flash card which is then analyzed at a later date. Telemetry monitors are used for live viewing of your heart activity. This is especially useful for drugs that may have an abnormal effect on the heart and the study staff can see any changes immediately. Whether you wear either monitor, men should shave their chests at the locations the pads will go. The pads must have a clean contact to the skin. The staff will shave your chest for you and it will be a dry shave, so do yourself a favor and do it beforehand. Make sure you do not use any lotions or aftershave on your chest as they will also interfere with the connectivity. Depending on the clinic or study sponsor, they may use a pad which is basically sandpaper to rub your skin a bit to further enhance the connection. Once you are finished wearing the monitors, remove the pads as soon as possible. Some people’s skin can get irritated by the pads and you will want to clean the area and apply lotion if you have it. If you are out of the study, you will want to apply some antibacterial crème to help heal if you are having a bad reaction.
