There are two types of clinical research, clinical studies and clinical trials. Some use these terms interchangeably; however, there is a clear difference between the two as noted below.
Observing people in their normal settings, researchers gather information, grouping subject according to broad characteristics and then comparing changes over time. These studies are sometimes called observational studies. Clinical studies may help identify the opportunity for a new clinical trial.
This type of research study is performed in people to evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new medical device, diet or drug is safe and effective in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Clinical trials can:
- help researchers detect disease early,
- help prevent a health problem,
- help make life better for those living with a life-threatening illness,
- help improve patients lives who are coping with chronic health issues,
- be used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment, and
- study the role of caregivers or support groups.
Each clinical trial has a protocol, or action plan, for conducting the trial. The trial’s protocol details what will be done in the study, how it will be conducted, and why each part of the study is not only included, but necessary. Each study defines its own rules about its participants. For example, some studies need volunteers with a certain disease, while others need healthy people and some only want men or just women.
Not just anyone can start a clinical trial. The U.S. Food and Drug Administration (FDA) must approve all clinical trials before they begin. Scientists must perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy first. If these studies show favorable results, the FDA will then give its approval for the intervention to be tested in humans.
Clinical Trials and Cancer Research
As noted above, before any new cancer protocol or plan is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. Based on the data that the clinical trials generate on safety and efficacy, they also seek to learn the side effects it may cause.
Clinical trials are important because there are people who are alive today due to the successful cancer treatments that have come from past clinical trials. These trials are the key to making progress against cancer.
Phases of Clinical Trials for Cancer Research
There are four phases to test a treatment, find the appropriate dosages and to look for side effects. After an intervention advances through the first three phases, with researchers finding the drug or other invention to be safe and effective, if the Food and Drug Administration (FDA) agrees, it will approves the intervention for clinical use, but that’s not the end of the FDA’s involvement. The FDA will continue to monitor its effects after its approval in Phase IV.
Here is more detail on the phases of clinical trials:
Phase I Clinical Trial
Clinical trial tests for an intervention are conducted on a small group of often-healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
Phase II Clinical Trial
This trial will include anywhere from one hundred to three hundred people. Researchers are working to determine the effectiveness during this phase. These trials can last several years and also continue to study safety, including short-term side effects.
Phase III Clinical Trial
More information is collected about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. Phase III can include anywhere from several hundred to upwards of 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
Phase IV Clinical Trial
Once the FDA approves an interventions use, the device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Costs of Clinical Trials for Cancer Patients
Clinical trials for cancer are not free. Thankfully, in the majority of cases, the patient is not the one who is paying. The majority of clinical trials are federally or privately funded, so there is no cost to the cancer patient. If you or your loved one is concerned about the cost of cancer treatment, consult with your doctor and your insurance company.
How to Find a Clinical Trial for Cancer
A well-respected organization offering a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and abroad is NIH.gov.
NIH conducts clinical research trials for many diseases and conditions, including cancer, Alzheimer’s disease, allergy and infectious diseases, and neurological disorders. To search for other diseases and conditions, visit ClinicalTrials.gov.
A NIH-funded initiative to connect people who are trying to find research studies, and researchers seeking people to participate in their studies is called ResearchMatch. This is a free, secure registry to make it easier for the public to volunteer and to become involved in clinical research studies that contribute to improved health in the future. Visit ResearchMatch.org for more information
About Leaf Vertical, Inc.
Leaf Vertical Inc. is an innovative, clinical-stage biopharmaceutical research company, committed to discovering and developing novel therapeutics from its proprietary cannabinoid product platform.
For more information on Leaf Vertical or its Cannabinoid (CBD) clinical trials, use in the treatment of specific types of malignancies related to glioblastoma, myeloma, gastrointestinal, and breast cancer, when administered in conjunction with Standard of Care, please contact Leaf Vertical by phone at 407-776-9217 or visit the company’s headquarters at 805 S. Kirkman Rd, Suite 202, Orlando, Florida 32811.