A Step-By-Step Guide to Clinical Trials
Thinking about joining a clinical trial? At first glance, joining a clinical trial may seem risky and confusing. We've created this step-by-step guide to help you better understand the process and phases of clinical trials, along with the interventions that have been put in place to ensure your safety and well-being is our priority.
To start, what exactly is a clinical trial?
Clinical trials are research studies that involve people. Through clinical trials, doctors find new ways to improve treatments and the quality of life for people with disease. Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the trial, called a protocol. The protocol explains what will be done during the trial. It also contains information that helps the doctor decide if this treatment is right for you. (www.cancer.gov)
What interventions are in place to ensure my safety?
You may have heard about the Tuskegee Study or of Henrietta Lacks and have some hesitations about the safety of enrolling in a clinical trial. But there are many rules and regulations in place to ensure that present-day clinical trials do not take advantage of participants, especially vulnerable individuals, which may include pregnant women, individuals of low socio-economic status, and the elderly. The IRB (Institutional Review Board), which will review the clinical trial, is also responsible for ensuring that the clinical trial doesn’t take advantage of individuals. This includes ensuring informed consent is received from participants, participants are not coerced to stay in the study and may leave at any time without an explanation, and that participants are always fully aware of the intervention throughout the trial.
What are the different phases of a clinical trial?
Clinical trials are divided into four phases, according to the American Cancer Society. Even though not all interventions in clinical trials involve drugs but for example an exercise routine or diet regimen, below is an overview of the phases a clinical trial involving a drug would undergo:
Phase 1: This is the first time a drug is being tested on humans, in which a very small sample is used. This phase focuses on the body's reaction to the drug and usually involves around a dozen participants.
Phase 2: This phase focuses on the extent of the drugs success, and includes a larger group of participants, roughly between 25-100.
Phase 3: The goal of phase 3 is to determine whether the newly tested drug is better than the conventional or standard drug. Clinical trials at this stage typically have at least several hundred participants and tend to be longer.
After phase 3, drugs involved in a clinical trial can apply for FDA approval.
Phase 4: Drugs in stage 4 are already FDA approved and typically involve thousands of participants. Drugs at this stage start to look at the long-term effects of the intervention.
Why should I join a clinical trial?
Today, people are living better lives from successful treatments that are the results of past clinical trials. Through clinical trials, doctors determine whether new methods are safe and effective and work better than current methods. When you take part in a clinical trial, you add to our knowledge that helps improve care for future patients. Clinical trials are the key to advancing health. (www.cancer.gov). Regardless of whether you are healthy or have a medical condition, your participation in a clinical trial can help make a significant contribution to medicine. If you have a disease, participating in a clinical trial could also allow you to receive the newest treatment or an experimental treatment for your condition and allow you to try alternative or additional treatment methods
How can I join a clinical trial?
You can search for clinical trials in which you may be able to participate as a volunteer using a tool called ResearchMatch. ResearchMatch is a free and secure registry developed by major academic institutions across the country who want to involve you in the mission of helping today's studies make a real difference for everyone's health in the future. Research Match can help "match" you with any type of research study, ranging from surveys to clinical trials, always giving you the choice to decide what studies may interest you.
Advancing Health Care Through Research: MedStar Health Patients' Stories
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A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
This site provides information on personal stories, ways to find clinical trials and even a glossary of common clinical trial terms.
NeedyMeds is an online information resource of programs that provide assistance to people who are unable to afford their medication and health care costs. All the information is free, easy to access and updated regularly. No registration is required and they do no request any personal information.
This site, created by the Office for Human Research Protections (OHRP), provides the public with basic information about research and research participation so potential volunteers can make informed decisions about participating in research.
CenterWatch provides patient with access to essential health and educational resources to learn more about clinical research and participation as well as other organizations that offer information and support for a range of medical conditions.
Expanded access is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). Learn more here.
Patient Advocate Foundation provides patients with arbitration, mediation and negotiation to settle issues with access to care, medical debt, and job retention related to their illness.
The Patient Travel Referral program provides information about all forms of charitable, long-distance medically-related transportation and provides referrals to all appropriate sources of help available in the national charitable medical transportation network.
"A clinical trial saved my life. It was the best decision I ever made....."
Photo: Mykal McEldowney, The Greenville (S.C.) News)
"I am a great example of the extraordinary multiple values of a clinical trial..." Read more here.
Jenny - Type 1 Diabetes Trial
"I participated in an NIH-funded clinical trial in high school because my mom has type 1 diabetes. Although I decided to participate to help the scientists learn more about my mom's condition, it ended up having a big benefit for me as well."
Juliana - Sickle Cell Trial
Juliana was born with sickle cell anemia, a condition in which the body’s red blood cells are sickle-shaped. It slows or blocks blood flow to parts of the body, causing intense pain called “crisis.” Hear Juliana tell her story about how participating in a clinical trial saved her life.
Nicholas - Sickle Cell Trial
"Participating in the studies, I think it helps the doctors figure out more about the disease and, you know, come out with more medicine and just help out everybody who has it," says Nicholas. "So their families and them won't be, you know, in pain crisis or in the hospital as much." (NIH)
KT - Hodgkin's Lymphoma Trial
Photo: KT Jones