Before you continue, if you haven’t yet, please read part one.
How do I go about commencing a clinical trial?
There are a few avenues you can take here. You can go straight to the scientists that specialize in the general topic that you want to make claims on (i.e., weight loss). These are usually done with a scientist/Ph.D. at a university or a company. Most of the scientists are International Society of Sports Nutrition members and can be found at the annual meeting. In my opinion, ISSN scientists are the experts in the dietary supplement field.
You want to be careful about hiring a company that does this for profit. A university is not a “profit center” and usually has no vested interest in the outcome of the study. The university and its scientists usually want solid science and unbiased results. Not to say that private companies do not want the same, but a company has to consider profit margins that are not usually aligned with an unbiased study. One of the challenges of working directly with a Ph.D./scientist is that they do not know the ins and outs of the law as well as an attorney. Why would they? It isn’t their job to know the law around substantiation; it is their job to know the science.
Thus, you should conduct the study with an attorney versed in claims and substantiation. The attorney can manage and oversee the trial. There are people and entities that will manage a trial, but if neither is an attorney devoting your funds to that end would probably be money not well spent.
How many participants do I need in my study?
It depends. A rule of thumb is 20 to 30 placebos and 20 to 30 who actually receive the product. The FDA and FTC want to see “more” participants. A higher number of participants in the control and active groups is always a good idea. Participants often fall out or drop out after enrollment, so you will need to enroll more than you want. Do they have to be an even split between men and women? And what about the age of the participants? Well, it depends. If you want to make claims for men and women, then your study needs to include men and women. The same goes for age. If you are not limiting your advertising to a certain age group, then you shouldn’t limit the study to a particular age group either though there will need to be some restriction to age (e.g., ages 18 to 60).
How long should the study be?
Not to sound repetitive, but it depends. If it is a study for weight loss, you will want a longer study, usually a minimum of 12 weeks. The longer the study, the less likely the study will fall under scrutiny. Obviously, the more participants and the longer the study, the more expensive the study will be.
Do I really need placebos?
Yes, the FTC has been very clear that it wants an active and control group in order for a fair comparison.
I have selected a university or a scientist to commence the study with the oversight of an experienced attorney. What’s next?
You will want to consider entering into a contract with the person(s) conducting the study to make sure that they do not publish the results of the study if you are not happy with the results. Otherwise, the scientist is likely to publish the results. Remember, researchers at universities are rewarded for publication of their works. Thus, the scientist will likely want to be able to share the results and publish the results of the study and that may not be in your best interest. It is best to establish this right away and lay everything out in a contract. You should also give your attorney the right to oversee the enrollment and the study itself to make sure things are going as outlined in the contract.
I have the results of the study. I’m happy and want the study published. What is the next step?
This is a slow process, unfortunately. It can take over a year to get a study published. The trial would have been approved by the IRB prior to commencement of the study. The scientist that performed the study should be able to offer some advice in this regard