All medications that are sold either by prescription or over-the-counter (OTC) must be properly tested in order to ensure that they adequately treat the condition that they were designed for and do not present a significant risk to the people that take them. New medications are first tested in animals (pre-clinical trials) so that researchers can acquire a better understanding for how the medications will react in humans. After animal testing is complete, researchers will then test the medication in humans, which is called clinical studies.
All clinical studies are overseen by two very important governing bodies, the Food and Drug Administration (FDA) and an Institutional Review Board (IRB). While the FDA’s primary focus is both the safety and efficiency of research studies, the IRB’s sole purpose is to protect research subject rights. Additionally, all clinical research studies are overseen by a Principal Investigator – a medical doctor trained to conduct research studies properly, safely and ethically. All of the Principal Investigators that oversee research studies at Clinical Trials of Texas, Inc. are Board Certified and have experience in treating patients within their own practices.
Participants/volunteers in clinical trials must meet the criteria required by the study protocol. Qualified participants who agree to participate in the study may be required to attend numerous study visits. At these visits, participants will be cared for by the clinical staff and study investigators. Visits may include the following: diagnostic tests, blood draws, questionnaires, physical exams, vital signs, study medication dispensation/return and more. Participation in a clinical research study is completely voluntary and participants are always made aware of what procedures they will be asked to complete prior to entering a study. Participants may also elect to withdraw from a study at any time.
Deciding to volunteer for a research study is an important decision. Because clinical research is necessary for the advancement of medical treatments, participating is, in a sense, a service to the community and the well-being of the human race. You may experience personal benefits as a result of participating, but there may be risks to participating as well. Participants should carefully consider their decision to volunteer for a research study and should ensure that they fully understand the requirements for participation as well as the potential risks and benefits of participation.
Benefits: Some participants may find that there are no real benefits to participating; however, there are numerous things that participants may receive as a result of participating. These things may include diagnostic testing, one-on-one physician assessments, study medication, and financial compensation. Every study is different; therefore, benefits may vary from study to study. All potential benefits of the study will be discussed with participants prior to entering the study.
Risks: While great measures are taken to ensure that clinical trials are as safe as possible, there are always risks involved with medical procedures and study medications. All risks of participating in a study will be explained to participants prior to entering the study. Participants must understand and agree to these risks in order to participate. Participants may drop out of a study at any time.