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, who 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 has to 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 their products continue to be beneficial and to meet the intended usage goal.
To learn more about clinical trials, visit the federal database of clinical trials.
Every clinical trial will have criteria which will 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 only healthy individuals. All clinical trial studies are designed so that all clinical trial participants are as similar to each 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 or not the treatment is effective.
Once a subject has been approved as a candidate for the study, there will be a number of visits the subject must make to the office. 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 general exam and medical history with research staff and the physician, as well as a review and signing of the Informed Consent. It is important that each subject understand fully the Informed Consent and the purpose of the study before agreeing to participate.
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 treatments 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.
Once a study phase has completed, all of the data is collected from each of the study sites around the country and the data is compiled into a report for the pharmaceutical 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.
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.
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 will 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 hour 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 (also called ICF, or Informed Consent Form). Each participant may withdraw from a study at any time and for any reason.
Yes, federal laws, and our ethical standards, require all Participants (also called Subjects or Volunteers) to be reimbursed for their time. Each trial pays different amounts, although our goals is reimburse the Participant about $50 per hour for time spent at the research site and for average travel time. Each trial pays at different times and please know that at Butchertown Clinical Trials we provide those reimbursements via prepaid debit card.