10 Steps of Clinical Trials at Franklin Health Research
Franklin Health Research (FHR) conducts clinical trials for natural products. A clinical trial is simply medical research that involves people like you. The following steps are used at Franklin Health Research to verify if a product is safe and effective for public use.
- Natural product companies develop a new product that they believe will improve the health of the public.
- In order for a company to make a claim such as 'clinically proven' or 'shortens the duration of a cold by 2 days' they must test the product in a clinical trial to be in compliance with the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).
- Natural Product Company contacts FHR about the product and medical claims that they are hoping to prove.
- Franklin Health Research designs a study protocol to balance the potential benefits and risks to participants, and answer specific research questions for the company. Some of the details outlined in the protocol include: the goal of the study, who is eligible to take part in the trial, protections against risks to participants, details about tests, procedures, treatments, how long the trial is expected to last, and what information will be gathered.
- FHR presents their plans to the company, so that all parties are in agreement about the details of the clinical trial.
- Franklin Health Research gets approval from the Institutional Review Board (IRB) for all clinical trials conducted. Most, but not all, clinical trials in the United States are approved and monitored by an IRB to make sure that the risks are reduced and are outweighed by potential benefits. IRBs are committees that are responsible for reviewing research in order to protect the rights and safety of people who take part in research, both before the research starts and as it proceeds.
- Once approval is received, FHR begins recruiting healthy volunteers to participate in research.
- Before a person can officially take part in a study they receive informed consent. Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. To help you decide whether to take part, members of the research team explain the details of the study. The informed consent document also explains risks and potential benefits. You can then decide whether to sign the document. Taking part in a clinical trial is voluntary and you can leave the study at any time.
- If you agree to participate in the clinical trial, you will receive the treatment or a placebo, which is an inactive product that resembles the test product, but without its treatment value. Being assigned to the treatment or placebo group takes place in a process called randomization. Randomization is the process by which treatments are assigned to participants by chance rather than by choice. This is done to avoid any bias in assigning volunteers to get one treatment or another. You will also be given detailed instructions on what health information is needed from you to study the treatment, and will receive compensation for time spent collecting data for the trial.
- After a clinical trial is complete, researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about the need for further testing. Your personal health information is never shared with the public or the company that has hired us the conduct the trial, and you will be among the first to know the results of the clinical trial. Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. Once a new product has been proven safe and effective in a clinical trial, a company may communicate those findings with the public and share that a product is clinically proven.
Find out more about getting involved in clinical research here!
References
"NIH Clinical Trials and You." National Institutes of Health, 9 February 2022, https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics