A clinical research team may include the people listed below. It is likely that as a participant you would mostly interact with the Principal Investigator, Sub-Investigator, and Clinical Research Coordinator during your time in the trial:
Prescreening of potential participants over the telephone, on a clinical trial website, or in person to work out their potential eligibility and suitability for a clinical trial is often a first step for recruiting people into clinical trials.
Questions that a potential participant is asked during prescreening usually focus on whether they may be able to take part or are definitely unable to take part, e.g. an individual's ability to attend multiple visits at the trial center. At this point in the process, only information that relates directly to a potential participant's eligibility and suitability for the trial is collected. Complete medical histories and screening physical exams are only conducted after the potential participant has signed an informed consent form. If you take part in any prescreening, you are not making a commitment to take part in a clinical trial.
Informed consent
Clinical trial regulation requires researchers to give potential participants complete written information about the clinical trial before they agree to participate. This is called informed consent. The information provided (the information sheet) must be written in a manner that allows them to understand all the trial details. If, after reading the information sheet, the potential participant still needs further clarification, the members of the trial team are required to help. No one should agree to participate in a clinical trial unless they fully understand the information sheet.
Before entering a trial, potential participants will be required to sign the Informed Consent Form (ICF) at the back of the information sheet provided. Signing the ICF demonstrates that the participant has been given this information and that they agree to participate in the clinical research trial. For people who are under the age of consent in their country, their parents/legal guardian will need to sign an Informed Assent Form to enable their child to take part in the trial. Even after they sign the ICF, participants can leave the trial at any time and for any reason without penalty.
You will not need to pay a fee to participate in a clinical trial, but you may need to pay for travel expenses to attend visits at the clinical trial center nearest to you. You may also need to pay for babysitting or childcare, and factor in lost income if the visits take place during working hours. Many clinical trials will provide compensation for any travel costs or other expenses incurred during participation, but you will need to check this with the trial team before agreeing to take part.
If the clinical trial is using an approved medication, then depending on your country of residence (e.g. the United States), your medical insurance may need to be billed. You can check this with the trial team before agreeing to take part.
The length of a clinical trial and how much of your time it will take up varies, depending on what is being studied. You will be told how long a trial will last before you decide whether to take part.
You will need to organize how you will get to and from the clinical trial center for trial visits. For some trials, you will be able to drive right after completion of the visit, but for other trials you may need to refrain from driving for a set amount of time. All this information will be made available to you prior to you deciding whether to participate in a clinical trial. Speak with the trial doctor to get their opinion on the best forms of travel. Someone in the trial team may be available to help arrange transportation for participants.
After a clinical trial is done, researchers (doctors and specialists) from the Sponsor analyze the data collected throughout the trial. If findings are positive overall, or there is further research required, the Sponsor may decide to conduct more clinical trials. Alternatively, they may decide to not go ahead with further testing because the drug was not safe or did not work well enough.
When a Phase 3 trial is completed, the data is analyzed to decide if the trial results are positive enough to warrant submission to government agencies, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, for the potential medication’s final approval.
After a clinical trial ends, participants are encouraged to keep in touch with the research team and, if the trial treatment was blinded, are entitled to ask the trial staff what treatment they were receiving during their time in the trial. The trial staff may be able to share this information with participants after the trial ends.
If participants request to see their data from the trial, trial staff may have to wait until the trial results are made public before sharing that information. Summaries of the results will be made available and/or provided to participants in easy-to-understand language soon after the trial has ended.
If there is no satisfactory approved medication, participants may be allowed to receive the investigational drug after the trial ends if they have responded well to it during the trial. However, this is rarely possible and first needs to be approved by the FDA.
Search this site for IQVIA-managed clinical trials, or visit ClinicalTrials.gov for a listing of all clinical trials.
You can also ask your doctor if they know of any suitable clinical trials.
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