AmbitCare
November 14, 2022
In this blog post, we will discuss what clinical trials are, the benefits of clinical trials, and how to find a clinical trial that is right for you and your loved one.
What is a Clinical Trial?
A clinical trial is a study or form of research that investigates the safety and effectiveness of new ways or drugs to prevent, detect, or treat a disease.
Clinical trials explore new:
- Drugs
- Combinations of drugs
- Surgical procedures
- Medical devices
- Ways to use existing treatments
Why should I participate in a clinical trial?
1. Access to Care
Clinical trials give you access to new and potentially disease altering treatments for free. Patients entered in a clinical trial also receive routine medical attention from doctors and researchers, so you may even receive more frequent health checkups than you otherwise would, all for free.
2. Be part of improving care for others
By entering in a clinical trial, you can contribute to the knowledge of new treatments. Your participation may help develop life altering medication not only for yourself, but for others with the same condition or symptoms.
How do I find a clinical trial?
- Ask your doctor
- Search your condition on www.clinicaltrials.gov
- If there is a patient advocacy organization for your disease, they may list relevant clinical trials on their website
- Finding clinical trials can be challenging. If you would like help navigating your search, please reach out to an AmbitCare Ambassador by calling 1877-584-8995 or emailing ambassador@ambitcare.com
How do I know if I or my loved one is eligible for a clinical trial?
All clinical trials have what are called inclusion and exclusion criteria. Inclusion criteria is a list of requirements you or your loved one must meet to enter the trial. Exclusion criteria is a list of conditions that if met, will disqualify you or your loved one from entering a trial. Some common factors that may affect your eligibility for a trial include your age, medical condition(s), genetic variant, or geographic location. Understanding the inclusion and exclusion criteria of clinical trials for your disease can help you narrow down your search.
What are the phases of a clinical trial?
Preclinical Research
Before a clinical trial can even take place with humans, it needs extensive preclinical research. Preclinical research allows researchers to understand whether the drug may cause serious harm. This research is not done on humans, as details on the dosing and toxicity levels of a drug must be reviewed before it can be tested in humans. While there are risks associated with clinical trials, it is important to know that when you enter a clinical trial, the safety of the drug being investigated has already been extensively researched.
Once the drug is approved to be tested in humans, it will undergo 4 trial phases of continued research.
Phase 1
The first phase of a clinical trial occurs only in a small number of people. The goal of phase 1 is to study the safety and side effects of the drug.
Phase 2
The second phase of a clinical trial occurs in a larger group of people, tests the effectiveness of the drug, and continues to review the safety. Sometimes Phase 2 trials are broken up into phase 2a and 2b. Phase 2a trials focus on dosing while phase 2b trials focus on the effectiveness of the drug.
Phase 3
The third phase of a clinical trial occurs in an even larger group of people (the exact number may vary). The goal is to confirm effectiveness, continue to monitor side effects and safety, compare the drug against standard or similar treatments, and better understand how the drug can be used safely.
Phase 4
Phase 4 occurs after the drug has been approved by the FDA and becomes available to all eligible patients. In this phase, researchers continue to track the safety, benefits, and optimal use of the drug.
What are the challenges with rare disease clinical trials?
Rare disease clinical trials face more challenges than other clinical trials. Because there are fewer patients, it can be difficult for researchers and sponsors to find enough patients to conduct the trial. There are over 7,000 different rare diseases, so awareness and understanding of an individual rare disease is often limited. A rare disease patient’s doctor may not know a lot about their individual rare disease. This often leads to the clinical trial search falling on the patient, making it much more difficult to know about and find relevant clinical trials.
Find a great children’s book on clinical trials called Courageous Calla and the Clinical Trial at the link here.
AmbitCare is here to help! If you are interested in learning more about clinical trials, contact an AmbitCare Ambassador who can connect you with more resources.
Call 1877-584-8995 or email ambassador@ambitcare.com.
Sources:
- https://www.nih.gov/health-information/nih-clinical-research-trials-you/why-should-i-participate-clinical-trial
- www.Clinicaltrials.gov
- https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research
- https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
- https://www.clinicaltrialsarena.com/analysis/clinical-trials-in-rare-diseases-conference-2021/
- https://resource-hub.globalgenes.org/kb/article/25-from-molecules-to-medicine-clinical-research/
