A clinical trial involving a medical device is a voluntary study designed to answer specific questions about the safety and effectiveness of the device, usually comparing the intervention with a device against a control group.
The potential benefits may include:
The potential risks of participating in a clinical trial vary depending on the trial itself. You should discuss the risks with your physician regarding the particular trial but they can include:
Adverse events may be mild, moderate, or severe, and may be caused by something other than the therapy being given.
Potential risks specific to your clinical trial will be identified and explained to you during the informed consent process. The doctor will speak to you about these potential risks and answer your questions.
Exploratory / Feasibility Study – Assesses the basic safety and potential for effectiveness of the device and design prior to the next stage of the trial, the pivotal study. It is generally a smaller population with the disease/condition.
Pivotal Study – Designed to reasonably demonstrate the device is safe and effective for a specific use within a defined patient population. The results of a pivotal study are used to obtain regulatory approval to make the device commercially available in the United States. Pivotal studies generally involve a larger number of patients than exploratory or feasibility studies.
Post-Market Study – Often required for high risk devices to assess continued safety and effectiveness and address specific questions about the post-market performance of or experience with the approved medical device.
No, it is illegal to be enrolled in a clinical trial without your consent.
You must sign an Informed Consent Form (ICF) prior to voluntarily agreeing to participate in a clinical trial. The ICF contains information about a trial needed to help you make a decision regarding participation. The goal of reviewing the ICF with you is to make sure you fully understand your rights as a research participant and get all your questions answered.
The ICF generally includes:
It is required that you sign and date the ICF before any study procedures can take place. You may withdraw consent and decline to participate at any time before or after signing the ICF without any loss of benefits.
Yes, you can withdraw from a clinical trial at any time without giving reasons. However, when withdrawing from the trial it is important that you let the research team know.
It is also important to note that the study doctor may choose to with draw you from the trial (e.g., terminate your participation) if new information becomes available that may affect your health or if you fail to follow the study requirements for follow-up visits, tests, etc.
Your confidentiality will be respected. However, research records, health records or other source records identifying you may be inspected in the presence of the study doctor or a designated representative of the study sponsor, the FDA, and other regulatory bodies.
No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law.
Other Federal law protective measures include:
Federal regulations require research records identifying participants be kept confidential to the extent permitted by applicable laws and regulations.
Federal law requires most health insurance plans to cover routine care costs in clinical trials under the conditions that:
Patients should speak with their insurers in the early stages of finding a clinical trial in order to learn about the general coverage offered and which clinical trial phases it is offered for. Once a patient has been selected for, or have chosen a trial, they should speak with their healthcare providers and insurance provider(s) to determine which costs related to participation are financed as well as the provider-payor contracting policies.
If you decide to participate in a clinical trial, you will be asked to:
When your participation in the trial is done, there may be other patients still participating due to different enrollment times. When the trial is officially completed, the results from the study will be available on www.ClinicalTrials.gov as soon as they have been made public.