Clinical trials involve human subjects and, as such, are subject to strict ethical and legal guidelines to ensure patient safety and welfare. Here are some of the protections that patients are given in clinical trials:
Informed consent: Patients must provide voluntary, informed consent to participate in the clinical trial. They must receive information about the study's purpose, risks, and benefits, and have the opportunity to ask questions and discuss any concerns before deciding whether to participate.
Ethical review: Clinical trials must be reviewed and approved by an independent ethics committeeto ensure that they adhere to ethical principles and do not pose unnecessary risks to participants.
Safety monitoring: Clinical trials have a designated safety monitoring plan to detect and manage any adverse events or side effects that may arise during the study.
Data confidentiality: Patient privacy and confidentiality are strictly protected, and all study data must be kept confidential and secure.
Patient withdrawal: Patients have the right to withdraw from the study at any time, without penalty or loss of benefits, if they feel uncomfortable or experience adverse effects.
Medical care: Patients participating in clinical trials must receive appropriate medical care and treatment throughout the study, whether or not they are receiving the experimental treatment.
Compensation: Patients may receive compensation for their time, travel, and expenses related to the clinical trial, but this must not be a coercive factor for participation.
In addition, there are numerous regulatory bodies that play a crucial role in ensuring that clinical trials are conducted safely and ethically, and that new treatments are safe and effective for patients. These include, but are not limited to:
The Food and Drug Administration (FDA) is the main regulatory body for clinical trials in the United States. It sets the standards for the safety and efficacy of drugs, biologics, and medical devices, and oversees the review and approval process for new treatments.
The International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use is a global organization that develops guidelines and standards for the pharmaceutical industry, including those for clinical trials. The ICH guidelines are used by regulatory bodies in many countries to ensure the safety and efficacy of new treatments.
Institutional Review Boards (IRB) are independent committees that are responsible for reviewing, approving, and monitoring biomedical and behavioral research involving human subjects. The IRB is composed of members with diverse backgrounds, such as scientists, physicians, ethicists, and community representatives. The primary role of the IRB is to protect the rights and welfare of human research subjects. Before a research study can begin, the IRB must review and approve the study protocol, informed consent process, and other related documents to ensure that the risks to the study participants are minimized, the benefits of the study outweigh the risks, and that the participants are fully informed about the study and its risks. The IRB also has the authority to monitor the progress of the study, to conduct periodic reviews to ensure that the study is still meeting the ethical and safety standards, and to make recommendations or take actions if any problems or concerns arise during the study. You can find more information on UCI’s IRB website.
These protections aim to safeguard the rights, dignity, and well-being of patients participating in clinical trials.
Participation Cost
The costs to participants in clinical trials can vary depending on the type of trial. In some cases, the study sponsor may cover all or some of the costs associated with participation, such as the cost of the study drug, medical procedures, and tests. However, in other cases, the study may require the participant’s insurance to cover some standard of care procedures, such as physicals, surgeries, scans, or medications. The participant could also be responsible for some of the out-of-pocket costs associated with the study, such as transportation, lodging, or meals.
It is important to note that most clinical trials are conducted at no cost to the participants, and in some cases, participants may even receive compensation for their time and travel expenses. Additionally, many trials offer access to cutting-edge medical treatments that would otherwise be unavailable to the general public.
Before deciding to participate in a clinical trial, it is important for participants to carefully review the study’s informed consent documents to fully understand any costs or financial obligations associated with participation. Participants should also feel free to ask our study team any questions they may have about the costs of participation and any potential financial implications.
Phases of Clinical Trials
The various phases of clinical trials are intentionally designed to delve into the effects of treatment or therapy on patients, ensuring that each trial is rigorously tested and evaluated:
Phase I
Phase II
Phase III
Phase IV
Reason
Safety
Safety & Dosing
Safety & Efficacy
Post-Marketing Safety & Efficacy
Duration
Several Months
Several Months
Several Years
Ongoing following FDA Approval
Population
Healthy Individuals
Individuals with target disease
Individuals with target disease
Individuals with target disease, as well as new age groups, genders, etc.
In Phase 1 trials, the focus is on assessing the safety of a drug. These studies involve a small number of healthy volunteers, and the goal is to identify the most common and serious adverse events associated with the drug. Researchers also study how the drug is metabolized and excreted by the body.
Phase 2 trials are designed to collect preliminary data on a drug's efficacy in people with a specific condition or disease. Participants receiving the drug are compared to those receiving a placebo or a different treatment. Safety is still a primary concern, and short-term adverse events are closely monitored.
In Phase 3 trials, the scope widens to include larger populations and different dosages. Researchers may also study the drug in combination with other medications. The goal is to gather more information about the drug's safety and effectiveness.
Once a drug has been approved by the FDA for marketing, Phase 4 trials may be conducted to gather additional information. These include post-market requirements and commitment studies, which are typically required of or agreed upon by the study sponsor. The focus is on gathering information about a drug's safety, efficacy, and optimal use.