Clinical Trials FAQs

A research study, or clinical trial, is a study in which participants receive investigational treatments while under the supervision of a physician and research staff members. The investigational treatments are developed by pharmaceutical, drug, device, implant, or diagnostic testing companies. These companies then select qualified physicians to act as investigators for the study and 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. First, everything under development must be proven not to be harmful. Next, items under development have to be shown to be beneficial (also called “meeting clinical endpoints”), and finally, after the FDA approves of the device, drug, implant, etc., most companies conduct “post-market” trials to verify that their products continue to be beneficial and meet the intended usage goal.

To learn more about clinical trials, visit the federal database of clinical trials. 

Every clinical trial will have its own criteria to determine who exactly can participate in the study. Some studies require a specific disease or condition for a participant to be included, like Dry Eye Disease or Glaucoma, while other studies may require healthy individuals. All clinical trial studies are designed so that all clinical trial participants are as similar each to other as possible.

Participants for the study, or study subjects, 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.

In most cases, not even the physician or research staff will know if the subject is receiving the actual treatment or the alternate. This allows an objective way to gather data on whether the treatment is effective.

Once a subject has been approved as a candidate for the study, there will be several visits the subject must make to the study site. Specific details of each visit will be outlined in the Informed Consent packet every subject will be given to sign. The first visit will consist of 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 subject fully understands the Informed Consent and the purpose of the study before agreeing to participate. The rest of the first visit may include other questionnaires or assessments specific to that study.

After all study visits have been made by the subject, the study staff and physician may require periodic follow-up visits or phone calls to determine the longevity of the treatment’s effects.

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. Typically, each study subject will be given a number or initials so that their identity will remain 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 packet.

Once a study phase has completed, all the data is collected from each of the study sites around the country, and the data is compiled into a report for the sponsor company and the Food and Drug Administration (FDA). These companies 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 drug or treatment has been approved, there may be more studies performed using the treatment to compare its effectiveness against other treatments already on the market and available to consumers.

After you finish participating in a study, you may be wondering if you can continue to access the treatment that was being provided. While researchers are not obligated to offer continued access to the treatment they’ve provided, they are required to inform you about your options before the study even begins. The doctors should outline if the treatment will be available after the study ends, also other treatments that may be beneficial to you. Sometimes the completion of one study will automatically make you eligible for the future studies with the same indication.

Deciding to participate in a clinical trial is completely voluntary. Subjects who participate in clinical trials are helping to further medical treatments for many diseases and chronic issues. However, there are both risks and benefits associated with clinical trials of which all participants should be aware.

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 all participants to be reimbursed for their time. Each trial pays different amounts, although our goal is reimbursing the participant about $50 per hour for time spent at the research site and for average travel time. Each trial pays at different times. Please know that at Butchertown Clinical Trials, we provide those reimbursements via a prepaid debit card which is paid 4-6 weeks after your last study visit. Once funds are loaded to the card you will be notified by text message.

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.