Clinical Trials-Cannibis Science via Patients Out Of Time
Clinical trials involve studies of a potential medication with real patients. The gold standard for a drug to be approved as medicine is to have randomized double-blind placebo-controlled clinical trials to validate the efficacy of such drug. Double blind means that the patients and the medication dispensers do not know which medication (test drug or placebo) is being given at any time during the study. Placebo-controlled means that the effects of drug to be studied will be compared to the effects of a placebo given to a patient population. The U.S. federal government, legislators, law enforcement officers and many healthcare professionals often use the “lack of clinical trials” with cannabis as a legitimate reason for continuing the marijuana prohibition. The Catch 22 here is that the federal government has made it virtually impossible for researchers to study the therapeutic efficacy of cannabis.
Patients Out of Time strongly believes that there has been more than enough research to validate that cannabis is a safe and effective medication.
Patients Out of Time strongly supports clinical trials with cannabis. The Institute of Medicine’s 1999 report on Marijuana as Medicine: Assessing the Science Base (pdf) noted the safety of cannabis and recommended that doctors be allowed to conduct n of 1 studies (n refers to the sample size, thus it would be a study to evaluate the effects of a drug on one patient). In other words, a doctor should be allowed to prescribe cannabis to a patient who is not responding to current treatment to see if cannabis would be effective. All practicing doctors should be able to do such studies that can eventually result in large numbers. At the same time, large well designed clinical trials are strongly recommended for various patient populations.