About Research and Clinical Trials
Before you participate in a clinical trial, you’ll want to know more about how it works and what to expect. We’ve assembled some frequently asked questions about clinical trials to help you get started. Your physician will be able to tell you more details as they relate to you and your personal situation.
What Is a Clinical Trial?
Clinical trials, also called clinical studies, are research studies with people. Each trial is designed to answer specific scientific questions and to find better ways to prevent, detect or treat diseases or to improve care.
Clinical trials are divided into four phases. Each phase is designed to discover new information about the drug or treatment.
- Phase I trials are the first step in testing a new approach. In phase I trials, a new drug or treatment is tested first in a small group of people to evaluate safety and dosage and identify side effects. This phase of testing is associated with the highest amount of risk.
- Phase II trials further evaluate the effectiveness and safety in a larger group of people.
- Phase III trials evaluate a drug or treatment in a larger group of people to confirm effectiveness and monitor side effects, and compare it to commonly used treatments.
- Phase IV trials further study a drug or treatment, collecting information about the effects in various populations and any side effects associated with long-term use.
Are Research Studies Confidential?
Yes. Confidentiality is guarded for all patients. Investigators’ files and records are secured so that all identifying information is protected.
Does My Health Insurance Cover the Costs of a Clinical Trial?
Possibly. Many insurance plans and Medicare cover costs of routine care in many clinical trials, especially phase III trials. Make sure to check with your health insurer before enrolling in a clinical trial.
Can I Leave the Clinical Trial at Any Time?
Yes. Participating in a clinical trial is voluntary. You can change your mind at any time after entering a trial. You may also refuse to take part in any aspect of the research.
What Protection Do I Have As a Patient in a Clinical Trial?
Clinical trials have the same ethical and legal codes that govern medical practices. In addition, most clinical research is federally regulated or federally funded (at least in part), with built-in safeguards to protect patients. These safeguards include regular review of protocol and the progress of each study. University Health has designated the review of their research protocols to the Institutional Review Board at UT Health San Antonio.
Términos comunes utilizados en los ensayos clínicos
¿Qué es un grupo de control?
Un grupo de control es el término que describe el estándar con el que los investigadores evalúan las observaciones experimentales. En muchos ensayos clínicos, a un grupo de pacientes se le administra un medicamento o tratamiento experimental, mientras que al grupo de control se le administra un tratamiento estándar para la enfermedad o un placebo.
¿Qué es un placebo?
Un placebo es una pastilla, un líquido o un polvo inactivo que no tiene ningún valor terapéutico.
¿Qué es la aleatorización?
La aleatorización es un método basado en el azar que determina cómo se asignan los participantes a un grupo de tratamiento. La aleatorización distribuye de manera equitativa a las personas con características específicas, lo que minimiza las diferencias entre un grupo y otro.
¿Qué es un estudio doble ciego?
Un estudio doble ciego es un ensayo clínico diseñado de tal manera que ni los participantes ni el personal del estudio saben qué participantes están recibiendo el medicamento experimental y cuáles están recibiendo un placebo (u otra terapia).
¿Qué es un protocolo?
Un protocolo es un plan de estudio para el ensayo clínico. El plan está cuidadosamente diseñado para proteger la salud de los participantes y, al mismo tiempo, responder preguntas específicas de investigación. Un protocolo describe qué tipo de personas pueden participar en el ensayo; el calendario de pruebas, procedimientos, medicamentos y dosis; y la duración del estudio.
¿Qué es el consentimiento informado?
El consentimiento informado significa que a usted, como paciente, se le brinda información para que pueda comprender en qué consiste un ensayo clínico, incluidos los posibles beneficios y riesgos. Entonces podrás decidir libremente si quieres participar o no. La mayoría de los estudios exigen que se cuente con el consentimiento informado.
What are exclusion/inclusion criteria?
Exclusion and inclusion criteria are the medical or social standards that determine if you may or may not be allowed to enter a research study. These criteria are generally based on such factors as age, gender, the type or stage of a disease, previous treatment history or other medical conditions.
What is a contraindication?
Contraindications are specific circumstances when the use of certain treatments could be harmful.
Medicamentos y dispositivos médicos
What are investigational drugs?
An investigational drug is one that is under study but does not have permission from the U.S. Food and Drug Administration (FDA) to be legally marketed and sold in the United States, or used for an unapproved purpose. The FDA is the federal agency that approves and oversees drugs and biologics in the United States.
What is the role of the research pharmacist?
At University Health, the research pharmacist’s role includes preparing and dispensing investigational drugs, ensuring that you receive proper doses at proper times as defined in the research protocol. The research pharmacist is the only individual who knows if you’re receiving the study drug or placebo. They keep records and ensure research staff are educated on the investigational drugs.
Are investigational drugs ever used before FDA approval?
Compassionate use of experimental therapeutics before FDA approval is referred to as compassionate use. This procedure is used with very sick individuals who have no other treatment options, and requires individual approval.
¿Qué es la eficacia de un medicamento o tratamiento?
La eficacia se refiere a la capacidad máxima de un medicamento o tratamiento para producir un resultado, independientemente de la dosis. Un medicamento supera las pruebas de eficacia si resulta efectivo en la dosis probada y contra la enfermedad para la que se receta.
What is a medical device?
A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease." Medical devices can be anything from thermometers to artificial hearts to at-home pregnancy test kits. The FDA reviews and approves devices through investigational studies.
