Clinical trials are medical research in which people are the subjects. These studies help researchers find new treatments for serious illnesses such as cancer. There are different types of clinical trials, but this post focuses on trials to test new drugs or treatments.
For some people with terminal illnesses, clinical trials are lifesavers and/or life extenders. Clinical trials gave my younger sister extra years with her two young daughters. Her children were infants when she was diagnosed with a rare cancer called GIST or gastrointestinal stromal tumour. When doctors found her cancer, it had spread to several locations including her liver.
Maura was afraid she would miss so much of her girls’ lives. Thanks to her participation in several clinical trials, Maura lived for ten years following her cancer diagnosis. Most of the time, her quality of life was good and she cherished every moment with her girls. She did everything she could to have more time with her girls and clinical trials gave her that time.
According to the American Cancer Society, not enough trial participants results in incomplete trials, this slows medical research. There are varieties of reasons that people give for not participating in clinical trials including lack of awareness of these studies. I want to increase awareness of clinical trials as I saw how my sister benefitted from them. Therefore, I became a Cure Click Ambassador and added a clinical trial search tool to this website. The search tool by TrialReach is in the sidebar on the right hand side, It looks like this:
Types of Clinical Trials
According to the National Institutes for Health, clinical trials are set up for:
- Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition.
- Finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches.
- Evaluating one or more interventions aimed at identifying or diagnosing a particular disease or condition.
- Examining methods for identifying a condition or risk factors for that condition.
- Exploring and measuring ways to improve the comfort and quality of life of people with a chronic illness through supportive care.
Getting approval to run a clinical trial
In the United States, a drug company that wants to offer its medication to US consumers must prove to the Food and Drug Administration (FDA) that the drug is safe and effective. To get this proof, drug companies conduct clinical trials.
A physician, known as the principal investigator, usually sets up clinical trials. The physician may have the backing of a drug company, government agency or medical facility. The doctor heading the trial at a hospital submits a detailed protocol to the hospital’s Institutional Review Board (IRB).
The principal investigator also submits a draft informed consent form to the IRB. The informed consent form is the document that trial participants sign before they take part in a clinical trial. By signing this form, patients acknowledge that they are aware of the potential risks and benefits of participating in the clinical trial.
The IRB reviews the protocol and informed consent form. The purpose of this review is to “to make sure that the study is ethical and the rights and welfare of participants are protected.” The trial can begin recruiting participants if the IRB approves the protocol and consent form.
Who takes part in clinical trials
The protocol for a particular clinical trial includes the eligibility criteria for participating in the trial. Typical criteria include:
- Having a specific diagnosis.
- Being over 18.
- Not being on another drug for a period.
- Ability to take medicine orally.
- Having adequate organ function as measured by lab tests, ekgs, x-rays, etc.
The protocol for a clinical trial also has exclusion criteria. Some common exclusions are:
- Being pregnant.
- Prior treatment with other named drugs.
- Other chronic disease (HIV, Hepatitis, Diabetes, Heart Disease).
- Participation in another clinical trial.
- Not meeting other medical criteria.
Some people investigate clinical trials as a last resort. At this stage, their health is poor and they may not meet the eligibility criteria for a clinical trial. So, if you or a loved one has a serious illness, talk with your doctor early on about clinical trials that may suit you. If you are considering a clinical trial for a serious illness, discuss all available trials with your physician as being in one trial may exclude you from others.
How Patients Find a Clinical Trial
Some patients find out about clinical trials from their own physicians. Others find out through patient support groups. Patients may also find a clinical trial by using the global database on the website centerwatch.com or at clinicaltrials.gov.
TrialReach provides a patient friendly search tool for clinical trials. Begin by using the search box in the column on the right hand side of this page.
Phases of a Clinical Trial
A clinical trial involves several phases described below.
The first phase of a clinical trial is for:
- Determining if a drug is safe.
- Finding out what is a safe dosage.
- Evaluating side effects.
In this phase, the testing of a drug’s safety and efficacy involves a larger number of participants.
The third phase of a clinical trial involves an even larger group of participants – (1,000 – 3,000). Researchers monitor the drug’s effectiveness. They also check for side effects and compare it with conventional treatments.
At this stage, the drug has FDA approval. Its usage is monitored for safety and effectiveness.
Points to remember when considering participation in a clinical trial
- Before testing a new drug or treatment on people, some preliminary safety research is done including:
- The “preclinical” stage where researchers investigate the safety of a drug in the laboratory.
- The submission of an Investigational New Drug (IND) application to the FDA.
- Before agreeing to participate in a trial participants must give informed consent. The FDA states that before giving informed consent, potential participants should understand:
- They may not benefit from the clinical trial.
- They may be exposed to unknown risks.
- They are entering a study that may differ greatly from the standard medical practices they know.
- What will be done to them.
- How the protocol (plan of research) works.
- What risks or discomforts they may experience.
- That their participation is a voluntary decision.
- Participants can leave a clinical trial at any time.
- As a participant in a clinical trial, you are a research subject. The study goal is to address research questions and not your individual needs.
- In some clinical trials, participants receive a placebo instead of the study medication. This allows researchers to measure accurately the effects of the study medication. If a study involves the use of placebos, researchers must tell participants as part of their informed consent. Importantly, the protocol for some studies using placebos, allows patients taking the placebo to switch to the study medication if there are signs of disease progression.
- Almost 95-percent of trial participants state they would recommend participating in a clinical trial to friends and family reports, the Center for Information and Study on Clinical Research Participation.
More information on clinical trials
The following websites have detailed information on clinical trials: