The end of the clinical trial does not mark the end of all communication between you and the research team. Once treatment is complete- and the study is closed- participants should feel free to ask the trial staff what treatment they received. The study staff shares this information as soon as it is available (if they are allowed to do so). They will also share the clinical trial results when they become available.  

Fuente:  ClinicalTrialsAndMe

The length of a clinical trial depends on several factors, such as the type of illness and medication/device being researched. For example, if the study is conducting research on a treatment for a chronic condition, the participant will be observed for a relatively long period. However, a clinical study for an antibiotic may quickly conclude because participants complete treatment within a couple of days.  

Fuente: Novartis

Participants can be reimbursed for:  

• Gastos de movilización
• Hospedaje
• Pérdida de ingresos
• Comidas

¿Qué tipo de compensación pueden recibir los participantes?

Compensation for participation in a clinical trial can take many forms. It may include:  

• Monetary benefits   
• Payment and other additional benefits, if anything.
• Payments and reimbursement to make up for any inconveniences.

La compensación es más común en los ensayos de fase I con voluntarios sanos. Se entrega a los participantes como reconocimiento por su tiempo y como agradecimiento por su contribución a la ciencia.

Fuente: EUPATI

In some cases, participation in a trial will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for the drugs, devices, and services they provide. It is possible that your insurance company may not pay for some or all of the charges- and you may receive a bill for those costs. The informed consent form will describe any costs to you in detail. If the information in the consent form is unclear, you can ask the research team to explain/clarify any potential out-of-pocket costs before you sign the consent form. 

Fuente: Cedars-Sinai.org

Any changes or restrictions to your lifestyle during a clinical study depend on the protocol and treatment in question. In some cases, some clinical trials may have more limitations than others. 

Un ensayo estándar se desarrolla en varias etapas:

1. A screening Visit:  The investigational staff reviews the informed consent document and goes over your medical history. 
2.  Baseline Visit:  This visit may happen simultaneously with the screening visit. Here, you will receive the study medication/treatment/device. The investigational staff will also review the dosing with you. 
3. Routine Study Visits: These are periodic visits done throughout the study to track an individual’s progress during a clinical trial. At the visit, the study team may have to: 

• Acquire Bloodwork  
• Administer study treatment 
• Perform a physical exam 

Fuente: Uva Health

Depending on each clinical trial, requirements for that visit will change because each study will have a different set of criteria. Some studies may require various tests- others may have little to none. During the screening visits, the investigational staff will give participants an overview of the clinical trial and ask questions to see if they meet the study's requirements (outlined in the study protocol). The general tests and information required include: 

• Bloodwork  
• Routine physical examination  
• Review of medical history 

Fuente: Uva Health

Beneficios de los ensayos clínicos

• Puede recibir un nuevo tratamiento para una enfermedad antes de que esté disponible para el público.
• Le permite tener un papel más activo en el cuidado de su salud.
• Los investigadores pueden proporcionarle atención médica y revisiones médicas más frecuentes como parte de su tratamiento.
• Tiene la oportunidad de ayudar a los demás a conseguir un mejor tratamiento para sus problemas de salud en el futuro.
• Puede obtener información sobre grupos de apoyo y otros recursos.

Posibles inconvenientes que pueden presentarse en los ensayos clínicos

• El nuevo tratamiento podría tener posibles efectos secundarios.
• Es posible que el tratamiento no funcione como se pretende o que no sea tan eficaz como los tratamientos disponibles en la actualidad.
• Participar en un ensayo clínico implica un compromiso de tiempo. Es posible que tenga que pasar la noche o varios días en el desarrollo de un ensayo.

Fuente: NIH.gov

The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial. The Federal government has regulations and guidelines for the management of clinical research to protect participants from unreasonable risks. They require researchers to give prospective participants complete and accurate information on the precise nature of each step of a trial. Therefore, before joining a study, participants are given an informed consent document that outlines their rights as a participant. They are also provided with, details on the nature of the study, including any potential risks.  

Antes de participar en un ensayo clínico, se recomienda que investigue todo lo necesario acerca del estudio. Hable de sus preguntas e inquietudes con los miembros del equipo de salud que realiza el ensayo. Asimismo, hable del ensayo clínico con su proveedor de atención médica para determinar si el estudio es una buena opción o posible en función de su tratamiento actual.

Para más información, visite:

Fuente:  FDA.gov