A clinical study can save you tens of thousands of dollars by giving you valuable information to help you prepare your product for successful market launch. Additionally, clinical study data can help protect you and your company from liability, by supporting your product claims and/or demonstrating product safety. (On the flip side, if your product is found to be irritating, or cause a skin issue, with clinical study data, you’ll know ahead of time, and potentially save tens of thousands of dollars in product recalls!)
If you’re new to clinical studies, by following these 5 guidelines, we can help you set yourself up for a stress-free experience, (or at the very least, a less stressful experience, while you await your study results).
1. Assess what you would like to study. Is your study intended to assess product safety or substantiate claims? What claims would you like to make on your product label? Are these claims legal for cosmetic products? (Be careful NOT to make drug claims, as dictated in the FDA’s directive for labelling cosmetic products). What is your product intended to do? Look at the active ingredients – what are they intended to do?
Make a list of all of the assessments that you would like to make (safety and effectiveness). Sometimes we can assess more than one claim in a study, sometimes separate studies are needed for different claims. We can help you set up the best study for your dollar, if we know what you would like to know about your product.
2. Assess your budget. Sometimes, budgets are the constraining factor. If we know what it is, sometimes we can recommend claim or study parameter adjustments to help you stay with in it. We will always recommend the most comprehensive studies for your products, but we know that sometimes, it’s more important to test one claim over another (or ensure safety first). So, have you budget in mind, and we’ll help get the important stuff done first!
3. Prepare your timeline. Work backwards. When does the product go to market? When do the labels need to be printed in order to get to market by this date? It normally takes us 2 to 3 weeks to compile all study data and run the statistical analysis, plus the study time (sometimes a week long study, sometimes a 4 week to 12 week study, depending on the product and the desired claims). How much time will it take you to produce and send the required number of samples for the study? We usually require samples 1 to 2 weeks before the agreed-upon start date of the study.
A note about timing: We cannot make your products perform faster, and we definitely want to give your products ample time to have the maximum effect (should the claims warrant this), so keep this in mind when booking your studies. Give yourself as much time as possible, especially if you’re assessing safety, as tweaks to product formulations and re-testing may be necessary. A little extra time BEFORE product launch will save you tons of time (and dollars!), especially if we can prevent the headaches of launching an irritating or illegally labelled product.
4. Assess your product in house first. Pass it around to your co-workers. Does it feel nice? Does it cause irritation to anyone in your company? If so, you may want to look at tweaking the formulation a bit. Does it smell nice or at the very least, neutral? Remember, the first thing most of us do when purchasing a cosmetic or personal care product is OPEN it and take a whiff. Our volunteers usually do this too. If your product is stinky, it may bias their answers on the questionnaire, they may not comply with “dosage” (i.e. volunteers may use less because it smells bad, etc). We recommend doing everything you can to avoid having a product that smells too pungent or stinky. Another thing to look for is cream absorption. If your product is a cream or lotion, does it absorb well? This is another complaint we often get from volunteers – that a product does not absorb well, or it flakes off. This may require some formulation changes as well.
5. Obtain proper packaging. Make sure to send your samples in the packaging that you intend to put on the store shelves. Get samples of the packaging without labels. Packaging format (pumps, jars, compacts, bottles, etc.) can often have a big effect on quantity of product use, intended application, and potential for contamination. If you cannot get the packaging in time for your study samples to be sent to Evalulab, please try to obtain packaging as close as possible to the container that you will actually be selling.
If you have any questions regarding clinical studies, or how to prepare for them, please don’t hesitate to give us a call at (514)735-3253. We’re happy to help!
References:
http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm
