how to live with dietary restrictions

chances are, especially if you have dietary restrictions, you have been asked to participate in medical research. clinical trials, also referred to as market trials, have been an integral part of the united states’ drug testing for decades. the FDA (food and drug administration) has been in charge of approving new drugs and medical devices* since the late 1930s but required no proof of the safety of new treatments until the early 1960s. today, anything new must go through several phases of trials before earning approval.

*dietary supplements are currently unregulated

phase I is the first time a particular treatment has been given to humans. it is administered in a low dose, which is increased if no side effects occur. in phase II the same treatment is given, though participants are randomly assigned different dosages given in different ways. phase III is usually offered by community-based oncologists simultaneously conducting studies around the country/the world. some participants receive the standard treatment, others receive additional dosages containing the new treatment. in phase IV the treatment is observed under “real world” conditions. researchers look for any long-term or previously unseen side effects, such as toxicity.

the most common concerns about clinical trials are possible side effects, the possibility of receiving a placebo (secretly empty treatment) and an overall lack of explanation/understanding. if you’re worried about side effects, there are always risks of any study. according to the american cancer society, placebos are rarely used alone in cancer research. the ACS claims that most trials simply compare new treatments against the current standard treatment. sometimes a new drug is added to the standard but everyone gets at least whatever standard treatment is currently available. as for explanation, we’ll further explore this issue over the next few weeks.