A Guide to Cancer and Clinical Trials

We rarely think about where our medications come from, but every drug, whether it is an over the counter allergy medication or prescription-only chemotherapy treatment, has gone through a series of clinical trials years before it was ready to be released to the general population.

Clinical trials, as the name suggests, are trials or tests performed to evaluate the safety and effectiveness of drugs, procedures, interventions, and medical devices to determine whether or not they should be introduced to the public.

A clinical trial has several phases, and most of them begin at a lab when a scientist or researcher makes a discovery he or she thinks is worth pursuing because it has the potential to benefit lots of people.

After researchers discover a potentially beneficial treatment, they spend years working at the lab trying to understand the effects and mechanisms of their discovery. Because scientists work very hard at fine-tuning their discovery and making sure the observed effects didn’t happen by chance, it may take many years before the treatment is even tested on humans.

A cancer clinical trial is a research study to evaluate new medical interventions or treatments that can potentially cure or increase the quality of life of people with cancer. All clinical trials have at least one principal investigator (usually a doctor) that designs the research process and makes sure that the trial is ethical and justifiable. This is achieved using a research protocol.

A research protocol is a document that describes in great detail the research process including the rationale (justification) for conducting the investigation, the objectives, methodology to be used, inclusion and exclusion criteria for participants, and an explanation of how the safety of participants is going to be ensured throughout the entire trial.

Every year there are thousands of clinical trials going on all over the country, and many of them involve new surgical approaches, treatments or medications for cancer. Additionally, there are clinical trials for every type of cancer, so if you or a family member is considering enrolling in one, it is very likely that there is one out there for you.

Many people think that cancer clinical trials are only for those who are very sick or whose cancer is no longer responding to treatment. However, that is not always the case; researchers are always investigating treatments and procedures that benefit patients at every stage of the disease, and they even recruit healthy volunteers to test cancer-preventing strategies or interventions.

Each clinical trial has a very detailed set of criteria that outlines who can and cannot participate in the study and why. For example, inclusion criteria for a stomach cancer trial may include the following: patients with only the specific type of cancer investigated in the study (i.e stomach cancer), female or male volunteers between the ages of 21 and 65.

Exclusion criteria for the same study may include: participants who have undergone stomach surgery during the past 6 months, pregnant or lactating individuals, participants allergic to X component (that will be used during the trial and may put the individual’s safety at risk). In order to determine if a volunteer meets all inclusion criteria, researchers use screening methods including questionnaires and medical examinations.

For many people, the first question that comes to mind when thinking about enrolling in a clinical trial is: why should I? And while the answer will vary from person to person, these are some common reasons why individuals decide to participate in one:

First of all, research studies give you access to medications and therapies that are still not available to the general population, and with that, often times comes around-the-clock, personalized medical attention at leading medical centers that some individuals otherwise don’t have access to. However, it is also important to understand that clinical trials are, after all, experiments, so it is impossible to predict beforehand if the treatment will be effective or not.

Some individuals also decide to participate in a clinical trial because they want to help others down the line. Clinical trials, whether they end up producing an effective medication or not, contribute to the current medical body of knowledge and move us one step closer to finding better treatments, screening tests, diagnosis tools, and even cures for many conditions.

If you are interested in participating in a cancer clinical trial, ask your doctor or oncologist if you would be a good candidate for one and to help you find a study that’s appropriate for you. You can also find clinical trials by contacting your local hospital or university.