When it comes to our diva demands we know we’re up there with the Mariah Carey’s of this world. “Avoid exercise before your screening visit.” “Don’t eat poppy seeds.” “Bring in a whole bag of blue M & M’s.” OK maybe not the last one, but still, it must seem peculiar.
In order to better articulate our rationale we’ve compiled an obligatory inventory of FAQ’s. If, per chance, you are still perplexed by our off centre requests, please do contact us. If we hear you ask often enough we might just add it to the list.
Ever wondered why we ask you to avoid exercise before the screening visit?
When you exercise, your blood is affected. Your white blood cell count can rise then fall and also your Creatine Kinase (CK) levels are affected. CK is a protein in your body and we want to make sure you have a “normal” level of it. Exercising even two days before a blood test can mean that you have elevated CK levels, which then means your results are out of the “normal” CK level range. Make sense? While there’s nothing to worry about if you have a high CK level due to exercise, it does mean that you will not meet the criteria for the study. We have your best interests at heart.
So I take recreational drugs once in a while… why is that a problem?
So marijuana, or more specifically THC which is contained within, can be detected in your system for up to 4 weeks. This varies based on levels and frequency of consumption. Engineered pills and powders will probably be out of the system within a week but again this can vary. Any foreign toxins in your system will skew our results and that’s not cool hence bombardment of quizzical queries when we chat to you.
Why are you taking lots of little blood samples?
In order to maximise the knowledge we gain from our studies we need to know what impact the medication is having every step of the way. It’s all a good idea to keep track from a safety perspective so we can pick up any unlikely abnormalities.
I did my time, what’s with all these outpatient follow up visits?
We miss you. Plus we’d like to see how you’re holding up. There may be a blood sample and a couple of tests required and we’d also like to know your thoughts and experiences in the intervening time between leaving us and coming back for a visit.
Why is it so important that samples are taken on time?
In the production of new medication or treatments no stone can be left unturned. We need to be absolutely sure what is happening and when it is happening. For example, a blood sample taken from you 15 minutes after you were dosed needs to be accurately compared with another person’s 15 minute blood sample so that we are getting an exact reflection of what the drug is doing. This accurate data then allows us to move towards the next phase of the clinical trial, the sooner we do that, the sooner the treatments can get to the people who need them most.
So what happens next, where does the study go after this part?
After we complete our end, the medication moves into phase II. Here the medication is tested in patients; the people who are in need of the treatment.
What are these sentinel and remainder groups I keep hearing about?
Nothing to do with Star Wars unfortunately. Sentinel is the lead group, so these will be the first people taking part in the study and remainder explains itself. The rest of the gang.
Why do I have to stay over as an inpatient?
So we can monitor you. Primarily for your safety, and also to collect data quickly and efficiently once it presents itself after dosing. Fun activities like taking blood samples, checking vital signs and ECG’s must also take place in a timely fashion. This takes place in accordance with the time you are dosed.
Why do we have to fast for some studies but not others?
Some studies may require us to test your fasting glucose (blood sugar) levels. Asking you to fast, usually 8-10 hours prior to the visit, ensures that your results are not influenced by any food or drink in your system and can be correctly interpreted.
Why do you keep telling me to drink lots of water?
There are a few reasons why we advise you to drink plenty of water:
- Obvious health benefits.
- If you have to fast for your visit, drinking water really takes the edge off those hunger pangs.
- It ensures a smoother blood draw. Blood is about 50 percent water, so the more water you drink, the plumper your veins become and the easier it is for us to locate your veins and extract a sample.
- A urine sample can be obtained more easily.
Why do I need to avoid poppy seeds? I love poppy seeds.
As part of our screening, we will do a urine drug test. This is to ensure that you have not been taking recreational drugs. A positive result will mean you are ineligible to participate in the study you are screening for. So why give poppy seeds a hard time? Well. Before they’re put into muffins, bagels, or cakes, poppy seeds can be found in poppy seed pods. Opium is found in those same seed pods—a milky substance that is extracted from the seed pods which contains morphine and codeine, among other pain relieving substances. While poppy seeds themselves don’t contain any opium, when the seeds are harvested they can become contaminated with the opium in the pod. Eating poppy seeds within a few days of coming in for a screening visit and you’ll run the risk of a positive opium result on the drug test.
Will exercise and alcohol really affect my results?
Yes. An important part of your screening visit is the blood test and each study has a strict result range that your blood results must fall within to ensure your eligibility. Strenuous exercise and alcohol consumption within 48 hours of your screening visit can affect various aspects of your blood results, an “abnormal” result from any aspect of your blood test could result in being excluded from the study. And neither of us want that now do we?