FAQs
Here are several questions that we get asked often leading up to the clinical trial process. We have done our best to answer them here for you.
A clinical trial is a research study in which participants (volunteers) receive investigational treatments under the supervision of a physician and research staff members. These investigational treatments are developed by pharmaceutical, drug, device, implant, or diagnostic testing companies that select qualified physicians to act as “investigators.” During the study, the investigators monitor the drug, treatment, test, device, or implant to determine the benefits.
The goal of all trials is to gain approval from the US FDA (Food and Drug Administration) for distribution, sales, and use in the United States. Everything under development must be:
- Proven not to be harmful
- Shown to be beneficial (also called ‘meeting clinical endpoints’
If the FDA approves the treatment, most companies conduct ‘post-marketing’ trials, which can verify that the products continue to be beneficial and meet the intended goals.
To learn more about clinical trials, visit the federal database of clinical trials.
Each trial has its own criteria to determine exactly who is eligible to participate. Some trials require a specific disease or condition for someone to be included, such as Dry Eye Disease or Glaucoma, while other studies may require ‘healthy’ individuals. All clinical trials are designed so that participants are as similar as possible. This helps show that the study’s results are due to the investigational treatment and not some other factor that differs between participants.
Study participants will typically be randomly assigned to one of two groups. One group will receive the study treatment, and the other group will receive either a placebo or a treatment already approved and on the market. Sometimes, there are more than two groups, with the dosages of treatments also differing.
In most cases, not even the physician or research staff will know what treatment the participant receives. This ensures that data on whether the treatment is effective remains objective.
Once a participant is deemed eligible for a trial, there are usually several visits at the study site. Specific details of visits are outlined in the Informed Consent provided to every participant. The first visit always includes a review and signing of the Informed Consent, as well as a general exam and medical history with research staff and the physician. It is important that each participant fully understands the Informed Consent and study purpose before agreeing to participate. The rest of the first visit may include other assessments or questionnaires specific to the study.
After a participant completes all study visits, there may be periodic follow-up visits or phone calls to determine the longevity of the treatment effects. This is also study dependent.
Your personal medical information will be accessible by the physician and their clinical research team, as well as by the company or sponsor conducting the study. Usually, each participant will be given an identification number so that their identity will be anonymous to anyone outside the physician’s office. This information is outlined in the Health Insurance Portability and Accountability Act (HIPAA) authorization that is included within the Informed Consent.
Once a study phase has been completed, all data collected from each study site around the country is compiled into a report for the sponsor company and the Food and Drug Administration (FDA). They will then determine if the study treatment is effective and has reached its ‘endpoints.’ If so, the company will present the treatment to the FDA for federal approval. After the clinical trial, you will not have access to the investigational drug unless it is approved by the FDA and then released to the market for general sale.
Even after a treatment has been approved, there may be additional studies to compare its effectiveness to other treatments or gain additional information while it is on the market and available to consumers.
When you complete your study participation, you may be wondering whether you can continue to access the treatment that was being provided. While researchers are not obligated to offer continued access to the treatment, they are required to inform you about your options before the trial even begins. The doctors should outline if the treatment may be available after the trial ends as well as other treatments that may be beneficial to you. Sometimes, the completion of one study will automatically make you eligible for future studies with the same indication and treatment.
Deciding to participate is completely voluntary. Participants in clinical trials are helping to further medical treatments for many diseases and chronic issues. However, participants should be aware that both risks and benefits are associated with clinical trials.
Benefits to clinical trials include:
- Participants will be taking an active step in their own health care
- Participants may have access to medical treatments before they are on the market
- Participants will have access to medical care and treatment throughout the trial
- The medical care and treatment received during the trial is always free of cost
- Participants (also called Subjects or Volunteers) are paid for their time during the trial
- Subjects are helping many more individuals by furthering medical treatments through clinical research
Risks associated with clinical trials:
- Sometimes, clinical trials may cause serious or life-threatening side effects. This will be detailed in the Informed Consent each subject is required to sign prior to going forward with the study
- Sometimes the treatment received through the clinical trial is not effective
- Some clinical trials may require multiple visits to the physician’s office, multiple medical tests, or even hours-long visits with the physician, which may not be possible for some subjects due to the amount of time involved
- All possible risks and benefits are outlined within the Informed Consent Each participant may withdraw from a study at any time and for any reason.
All possible risks and benefits are outlined within the Informed Consent Each participant may withdraw from a study at any time and for any reason.
Yes, federal laws and our ethical standards require that all participants be reimbursed for their time. Each trial pays a different amount; however, our goal as a site is reimbursing the participant about $50 per hour for time spent at our site and average travel time. Please know that at Butchertown Clinical Trials, we provide reimbursements via a prepaid debit card which is paid in full 4-6 weeks after your last study visit. You will be notified by text message when funds are loaded to the card.
If you or someone you know would be interested in finding out more about participating in clinical trials with Butchertown Clinical Trials, simply call our office at 502-219-7700.
Get Started Today
We regularly recruit patients (study subjects) to enroll in clinical trials sponsored by pharmaceutical companies, surgical and medical equipment firms, and others attempting to prove the usefulness of a new pharmaceutical agent, treatments, surgical implants, or diagnostic medical devices. View open trials today.