Clinical trials are a necessary part of the drug approval process. All drugs on the market, even the over-the-counter drugs, have gone through clinical trials. They ensure that the drug is safe and effective, and if that cannot be demonstrated then your company will not get the Food and Drug Administration's (FDA) stamp of approval to go ahead and market it. So, now that medical marijuana is becoming the real deal, when will this plant get its chance to go through the 10 to 15 year and highly expensive pipeline to make it to market approval?
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Well, that simple-sounding question actually has a very complex answer. First of all, do you want to get the actual plant, Cannabis sativa or indica approved? Well, have you patented this 5,000-year-old herb? Probably not, however, growers have been applying for patents for certain strains that were created through selective breeding. Will those patents be granted? Well, according to a landmark 1980 opinion, then-U.S. Supreme Court Chief Justice Warren Burger wrote that "eligibility for patent protection does not depend on whether the substance is living or nonliving. Rather, the key question is whether the inventor has altered nature’s handiwork to the extent the resulting invention can be deemed a nonnaturally occurring substance."
Okay, now we have a patented product that can (supposedly) continue down the path to market. And if you can patent and market your strain of marijuana, well then, you may be set for life...at least the life of the patent. But in between getting your intellectual property rights that come along with an official patent (which, in the United States, poses a specific set of problems due to the fact that Uncle Sam is still "saying no" to wacky tobaccy) and selling your dream strain as a medicinal product is a long series of nonclinical and clinical studies.
If you have that entrepreneurial spirit (a necessary attribute for anyone starting up in this business, along with investors) then you might actually make it. For the sake of brevity, let us skip over the nonclinical toxicology and safety studies in animals required before testing your drug (in this case, your strain) in people. Remember, we are operating under the assumption that the FDA would even allow you to get this far. However, you are not alone, intrepid marijuana grower. Several organizations are crying out for clinical trials of marijuana, especially in patients with terminal illnesses. One of them is a group called "Patients Out of Time".
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Patients Out of Time strongly advocates the use of double-blind placebo-controlled clinical trials for cannabis. And guess what? These trials are actually being conducted! The National Institutes of Health (NIH) ClinicalTrials.gov website listed 749 studies when the search term "cannabis" was used. These trials are taking place all over the nation in hospitals and universities. They are looking at a variety of different health issues and are using various forms of cannabis or synthesized cannabinoids. ClinicalTrials.gov is also a great way to get involved to get advanced medications out to the public. Are you willing to be a human guinea pig for medical marijuana?
Sources: www.fda.gov, caselaw.findlaw.com, theconversation.com, www.medicalcannabis.com, ClinicalTrials.gov