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What is a Clinical Trial Study?

Study Set-Up

Clinical trials are typically broken down into classifications based on the stage of development of the product. The Clayton Eye Center typically participates in Phase II and Phase III trials and has participated in Phase I and IV trials as well.
Phase II trials begin after the drug’s initial safety has been determined and are designed to determine the efficacy of the drug or procedure.
Phase III trials are conducted in larger patient groups than Phase II trials and are intended to be a conclusive assessment of the effectiveness of a treatment. The trials often times compare the experimental treatment with the most prevalent treatment already available on the market. After successful Phase III studies, the results are packaged with those of previous clinical trials and assembled into a “regulatory submission” provided to the appropriate regulatory agencies for review.
Phase IV trials are conducted after a treatment has received permission to be sold. They are designed largely for long-term safety surveillance, but are often also conducted for a variety of other reasons including assessing new markets or determining the efficacy on a particular population subset.

The informed consent process provides the subject with key information about a clinical trial before they decide whether or not to participate. Throughout the duration of the study any updated information is provided to participants.
The process begins with a thorough explanation of study details to prospective participants. They are then provided with an Informed Consent document to read through which explains key information about the study including: the purpose and expected results, risks and potential benefits, duration of the study, information regarding the visits, procedures which will occur, compensation if provided, and key contacts involved with administering and regulating the study. The prospective participant is provided with an ample opportunity to question the Principal Investigator about the study and has the opportunity to take home the informed consent to discuss participation with family. If the prospective participant decides that they would like to enter the study, then they, along with a member of the study team, will sign and date the informed consent document and a copy of that document will be provided to them.
It is important to realize that an informed consent is not a contract; participation in a clinical procedure is entirely voluntary, and the participant may withdraw from the trial at any time.

Participation in clinical research is not without associated risks. Experimental treatments often carry with them associated side-effects, both known and unknown. Additionally, patients might face the risk of an unknown allergy to a new medication, an unpleasant interaction between the new medication and a medication they are already taking, or the experimental medication might not have the desired effect.
Patients should also be aware of the amount of time participation will require. Often, studies require lengthy and/or frequent visits to the clinic, additional treatments, or participation requires following a complicated dosing schedule and documentation of proper adherence.

Institutional Review Board (IRB)
- Clinical research trials are approved and monitored by a 3rd party Institutional Review Board to ensure that the rights of study participants are protected. The IRB reviews and approves the informed consent document as well as all study related materials and procedures. Research sites must routinely submit information to keep the IRB current regarding the progress of their study and health of study participants.
Federal Regulations
- In addition to IRB oversight, clinical studies and participants are subject to the same regulations that exist in a traditional doctor-patient relationship. Clinics must abide by federal patient privacy laws (HIPAA) and observe good clinical practices ensuring subjects’ rights and well-being are preserved.
Primary Care Physician notification
- If the subject so chooses, their Primary Care Physician can be notified of their participation, what the study regimen will require, and any anticipated side effects. This can be beneficial in the event that a subject needs to visit their PCP for an unrelated matter or wants to determine how the study might affect another treatment plan.

Screening
- The Screening visit enables the patient to learn more about the study they are interested in, read through the informed consent document, and often times asses their eligibility for participation in the study. Each study provides a set of inclusion and exclusion criteria that must be satisfied for participation; frequently a patient will come in for the screening visit, be unable to satisfy all the requirements, and will not be allowed to participate in the study. For studies that provide compensation to subjects, all subjects are compensated for their time for the screening visit, regardless of study inclusion or exclusion.
Study Visits
- All studies are set-up differently in the visit schedule that they require. The commitment required can vary from as little as a single-visit to assess the severity of a condition to a study duration of a year or more requiring numerous visits to assess the long-term effects of treatment.

Participation in clinical research provides numerous benefits for subjects, including: allowing subjects an increased involvement in treating their conditions, gaining access to evolving treatments not yet publicly available, obtaining extensive medical care without significant cost, and for the opportunity to help contribute to finding new ways to fight disease.

More frequently asked questions about clinical studies can be found here (http://clinicaltrials.gov/ct2/info/understand#Q02) and additional information can be found here (http://en.wikipedia.org/wiki/Clinical_trial). Additionally, interested parties may contact Clayton Eye Center with questions regarding specific studies or with generic inquiries about the clinical research process.