Clinical Trials & Study Participation
Thank you for your interest in clinical trials! Clinical trials can be daunting if you’re unfamiliar with them, so we want to try to answer some potential questions you may have. If you have additional questions, please check out the links below or contact us!
Clinical trial participants include individuals of all ages and from all walks of life. Many times people volunteer for clinical trials to be a part of the future of medicine. Some also volunteer because they are looking for alternatives to the currently available treatments for a condition they are suffering from. Some individuals are also motivated by compensation. Compensation is usually provided for study participation time & travel.
Each clinical trial presents unique benefits which may include the following: direct medical benefits, medical exams & information at no cost to you, and the opportunity to provide information that may lead to treatments that help others in the future. You may also receive compensation for time and travel for participating in a clinical trial.
Each clinical trial presents unique risks related to the investigational medication or other medications you may take as part of your study participation. Risks may be minor, such as discomfort associated with the collection of blood samples, or they may be significant. It is important for you to understand all of the risks associated with any clinical trial in which you participate. All risks must be explained to you during the informed consent process.
Each clinical trial is reviewed by an independent ethics committee to ensure that the human rights of all study participants are protected and that no study volunteer is exposed to undue risk.
Clinical trials usually involve an investigational medication or study drug or an investigational medical device. “Investigational” means that the drug or device is not yet FDA approved either for the particular condition or dose being studied or for any condition. Most trials require participants to take at least 1 dose of the study drug, but some studies may require participants to take multiple doses of the study drug. Clinical trials may also include a comparator drug which is an FDA approved medication that is thought to have a similar effect as the study drug. Clinical trials often also involve a placebo or “dummy drug” which looks like the study drug but has no active ingredients. Some studies are “open-label” meaning participants and study staff are all aware of exactly what each participant is taking for each dose. Studies may also be “single-blind” which means that study participants do not know if they are taking the study drug, comparator, or placebo but the study team knows what the participant is assigned to. “Double-blind” studies mean that neither the study participant nor the study team know what treatment is assigned to each participant.
Clinical trials can last for any length of time from 1 day to several years and can consist of single or multiple visits to the site which may be outpatient or inpatient.
Here at Clinilabs Drug Development Corporation, our goal is to provide each study volunteer with the best clinical trial experience possible. Every clinical trial is different, and each trial has unique requirements to qualify as well as a unique study schedule. As a clinical trial volunteer, our study team will ask questions to ensure that you are appropriate for your clinical trial. The study team will make sure you fully understand what you are volunteering for and all your questions have been answered prior to any procedures being completed. Participation in a study does not require any medical insurance and is at no cost to you, and we provide assistance with transportation. The primary responsibilities of a volunteer are to answer all questions honestly, come to your study visits as scheduled, and follow the requirements of the individual study. Clinical trial volunteers reserve the right to discontinue trial participation at any time. You can also expect that your study team will be professional and knowledgeable and will protect your rights and safety at all times.
Links & References For More Information:
ClinicalTrials.gov – https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs
I must say, I spend a lot of my time these days trying to persuade people that controlled trials are the only way to get information that’s reliable about drugs.
– Louis Lasagna