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1 PowerPoint Slides English Text Spanish Translation VideoTranscript Estudios clínicos Transcripción del video Professional Oncology Education Clilnical Trials Time: 17:22 Duración: 17:22 Maurie Markman, M.D. Former Vice President Clinical Research The University of Texas, MD Anderson Cancer Center Hello, I am Dr. Maurie Markman, [Former] Vice President for Clinical Research at The University of Texas MD Anderson Cancer Center and I am going to be speaking on the topic of clinical trials. Educación Oncológica Profesional Estudios clínicos Dr. Maurie Markman Ex Vicepresidente Investigación Clínica Universidad de Texas, MD Anderson Cancer Center Hola. Soy el Dr. Maurie Markman, [Ex] Vicepresidente de Investigación Clínica en el MD Anderson Cancer Center de la Universidad de Texas, y voy a hablar sobre estudios clínicos. o Maurie Markman, M.D. Former Vice President Clinical Research 1

2 Objectives Upon completion of this lesson, participants will be able to: Define various endpoints for cancer clinical trials Distinguish between phase I, II, III and IV trials Identify ethical principles specific to clinical research The objectives of this lecture are to talk about: the various endpoints that are used potentially in cancer clinical trials; distinguish between the various phases of the trials; and very importantly discuss some of the important ethical principles that are specific to the conduct of clinical research. Los objetivos de esta disertación son hablar sobre los diferentes criterios de valoración que se pueden utilizar en los estudios clínicos de cáncer; distinguir entre las diferentes fases de los estudios y, fundamentalmente, analizar algunos de los importantes principios éticos que son específicos de la conducción de las investigaciones clínicas. What is a Clinical Trial? A methodical investigation of the outcome of an intervention used to treat a disease, or a clinical condition in patients The conduct of clinical trials requires rigorous methodology and design, as well as clinical expertise to monitor the treatment outcomes Ethical principles must be strictly observed The first question is: What is a clinical trial? Well it is, although different definitions can be used, it is a methodical investigation of the outcome of an intervention used to treat a disease or a clinical condition in patients. So although it clearly does include the treatment of a condition, for example, cancer, which is what we are going to be talking about largely, but it is to look at this in a systematic way to answer a question that would potentially --- that would potentially help future patients or members of society in the future. The conduct of clinical trials requires rigorous methodology and design. I am going to talk about some of that in a few moments, as well as expertise to monitor treatment outcomes. And very importantly, and we will discuss this in some detail, very important ethical principles must be strictly observed in the conduct of clinical trials. La primera pregunta es: qué es un estudio clínico? Si bien se pueden utilizar distintas definiciones, podemos decir que se trata de una investigación metódica de los resultados de una intervención empleada para tratar una enfermedad o condición clínica en los pacientes. Aunque está claro que incluye el tratamiento de una condición como el cáncer, que es a lo que mayormente nos referiremos, también debemos analizar esto de manera sistemática para responder a una pregunta que podría ayudar a futuros pacientes o a miembros de la sociedad en el futuro. La conducción de estudios clínicos requiere una metodología y diseño rigurosos. Me referiré a esto más adelante, al igual que a la pericia requerida para supervisar los resultados del tratamiento y, lo que es más importante, analizaremos en detalle los importantes principios éticos que deben ser estrictamente observados en la conducción de estudios clínicos. 2

3 Why Conduct? To look for effective therapies in diseases where no effective therapy is currently available To improve the effectiveness of available therapy To reduce the toxicity of therapy while maintaining known effectiveness of treatment To expand the application of a treatment strategy known to be active in one category of disease So, the next question is, why bother? Why conduct clinical trials? Well, there are number of reasons: First, it is critically important to look for effective therapies in diseases where no effective therapy exists currently; to improve the effectiveness of available therapies; to reduce the side effects or toxicities of treatment while maintaining the effectiveness of the treatment; and very importantly, when we already have an established treatment for a particular disease, that seems promising, to see if we can expand the application of that particular treatment strategy into other disease categories. La siguiente pregunta sería: para qué molestarse? Por qué conducir estudios clínicos? Existen varios motivos: en primer lugar, es muy importante buscar tratamientos eficaces para enfermedades que actualmente no tienen un tratamiento eficaz; para mejorar la eficacia de los tratamientos disponibles; para reducir los efectos secundarios o las toxicidades del tratamiento, mientras se mantiene su eficacia; y, fundamentalmente, cuando ya contamos con un tratamiento establecido para una enfermedad determinada que parece prometedor, para determinar si podemos ampliar la aplicación de esta particular estrategia de tratamiento a otras categorías de enfermedades. Endpoints of Cancer Must be prospectively defined within the protocol Response to treatment (complete, partial, biomarker) Duration of response Time to disease progression Side effects of treatment Quality-of-life Cost-effectiveness Survival What about endpoints in clinical trials? What are the goals? What are you trying to accomplish? Well, it is important to state that when you design a clinical trial, the endpoints must be prospectively defined within the protocol. What that means is you state at the beginning what you will consider to be a positive outcome and what you would consider to be a negative outcome. Because what you don t want to have happen is you have done all this work and then someone says, Well, you know, let s call it positive, because we saw this. No, no that is not the way to do research. You say, We think, for example, in this particular trial, that if 25% of the patients have responded, that we would consider that to be a positive outcome. And of course, if you achieve that, that is great. If you don t achieve that, the outcome would be negative. You don t define positive trial after the trial is done. And a variety of endpoints can be used, as I mentioned, response to treatment, that could be, for example, the cancer has gone away completely; you cannot measure it; maybe it has shrunk by 50%. Or maybe we are not actually looking at an actual size of a Y qué pasa con los criterios de valoración en los estudios clínicos? Cuáles son los objetivos? Qué se quiere lograr? Es importante señalar que, al diseñar un estudio clínico, los criterios de valoración deben estar potencialmente definidos en el protocolo. Esto significa que se debe indicar al comienzo lo que se considerará un resultado positivo y lo que se considerará un resultado negativo. No queremos que después de hacer todo ese trabajo alguien diga: Bien, digamos que es positivo, porque lo hemos visto. Esta no es la manera de realizar una investigación. Decimos: En este estudio en particular, consideraremos que si el 25% de los pacientes responde al tratamiento, eso es un resultado positivo. Y si se puede lograr, sería excelente; si no se logra, el resultado será negativo. No se puede definir un estudio como positivo después de haberlo realizado. Como mencioné, se puede utilizar una amplia variedad de criterios de valoración, como la respuesta al tratamiento, que podría ser que el cáncer ha desaparecido por completo, no se puede medir, o tal vez se ha reducido en un 50%. O quizás no estemos evaluando el tamaño real 3

4 Defining Efficacy and Toxicity Tumor response (RECIST criteria) Improved progression-free or overall survival (based on results of randomized trial) Standardized criteria to assessment of side effects (National Cancer Institute Common Terminology Criteria for Adverse Events) tumor that is either felt on physical exam or by radiographic imaging. Maybe we are using a biomarker, maybe we are using a blood test. And that is a perfectly reasonable endpoint in certain situations. Other endpoints might include the duration of response. Does it last two months, six months, three years? The time the disease is stable before it actually progresses, side effects of the treatment; important endpoints. The overall quality of life associated with patients treated in a trial. Increasingly, we are looking at issues of the cost effectiveness of the treatment. Not only is it positive from the point of view of what it does to the condition, but what about the cost and certainly the cost relative to other treatments that one might have for a condition. And finally, certainly in the case of cancer, survival, overall survival is a critically important endpoint. A variety of measures for effectiveness and toxicity have been defined: tumor response. We classically use what are known as RECIST criteria. These are criteria agreed upon by the International Cancer Community led by the National Cancer Institute, very specific criteria of what is a response: improved time to progression or overall survival. This is particularly when you are doing a randomized trial you are comparing treatment A to treatment B or treatment A to B to C. And for toxicity, we have a variety of agreed-upon elements that specifically define what is a serious adverse event versus a mild adverse event or moderate adverse event that has been agreed upon. This particular criteria that is used is a National Cancer Institute Common Terminology Criteria for Adverse Events. de un tumor que puede sentirse al tacto durante un examen físico o verse en una imagen radiográfica. Tal vez estemos utilizando un biomarcador o quizás estemos utilizando un análisis de sangre. Y ese puede ser un criterio de valoración perfectamente razonable en determinadas situaciones. Otras variables pueden incluir la duración de la respuesta. Dura dos meses, seis meses, tres años? El tiempo durante el que la enfermedad se mantiene estable antes de que realmente progrese, los efectos secundarios del tratamiento son criterios de valoración importantes. La calidad de vida general asociada con los pacientes tratados en un estudio. Cada vez más estamos ante cuestiones de la relación costoeficacia del tratamiento. No sólo es positivo desde el punto de vista de lo que hace por la condición médica, sino de lo que pasa respecto al costo y, ciertamente, al costo en relación con otros tratamientos que puede haber para una condición médica. Por último, y sobre todo en el caso del cáncer, la supervivencia. La supervivencia general es un criterio de valoración de importancia crítica. Se han definido varias medidas respecto a la eficacia y la toxicidad: la respuesta tumoral. Clásicamente, utilizamos los criterios conocidos como RECIST. Estos son criterios que han sido acordados por la Comunidad Internacional del Cáncer dirigida por el Instituto Nacional del Cáncer, y son muy específicos respecto a lo que es una respuesta: el mejoramiento del tiempo hasta la progresión o supervivencia general. Esto se aplica especialmente cuando se está haciendo un ensayo aleatorizado en el que se compara el tratamiento A con el tratamiento B, o el tratamiento A con el B y el C. En cuanto a toxicidad, tenemos una variedad de elementos ya acordados que definen de manera específica lo que es una reacción adversa grave en comparación con una reacción levemente adversa o moderadamente adversa. Estos criterios particulares conforman los Criterios de 4

5 Methods to Measure Endpoints Physical examination Imaging studies (including functional imaging) Laboratory tests (including biomarkers) Toxicity questionnaires Quality-of-life scales Financial analysis and life projection analysis There are a variety of ways of measuring endpoints. One can look at physical exam and various imaging studies. Increasingly, that includes functional imaging, commonly the PET scan, which can look at not only the size of the tumor potentially, but also whether there is evidence of active dividing cancer, for example. A variety of laboratory tests, and here again I will include biomarkers, toxicity questionnaires, quality of life scales, and, again, in the sort of discussion of cost effectiveness, we are beginning to increasingly look at financial analysis and life projection analysis. Terminología Común para Eventos Adversos del Instituto Nacional del Cáncer. Existen varias formas de medir los criterios de valoración. Se puede evaluar un examen físico y diferentes estudios de imágenes. Esto incluye imágenes funcionales, y comúnmente el escaneo con tecnología PET que puede mostrar el tamaño potencial del tumor y, por ejemplo, si existe evidencia de cáncer de división activa. Una amplia variedad de pruebas de laboratorio, que incluye biomarcadores, cuestionarios sobre toxicidad y escalas de calidad de vida. En el tipo de discusión respecto a la rentabilidad estamos comenzando a prestar cada vez más atención al análisis financiero y al análisis de proyección de vida. Study Design Hypothesis Scientific/clinical background Detailed treatment outline Tests and follow-up Modifications for observed side effects Endpoints and population well-described Statistical design fitting the hypothesis and endpoints So in designing a trial, there are a variety of issues that one must consider even before you put pen to paper and write the study. What is the hypothesis that you are trying to test? What is the scientific or clinical background supporting that hypothesis? You want to have a detailed treatment outline. How you are going to treat patients? How often do they have to come in? When do you repeat tests? What are those tests? What if toxicity is observed, the blood count goes too low, the patient develops mouth sores? How long do you wait before for you treat them again? How do you modify the dose? Maybe if you have several drugs, which doses do you modify? All of that has to be considered before the trial can be submitted for review. And then very importantly, as I mentioned, what are the endpoints in the trial? You want to describe the population that you are going to treat in the trial very carefully. And of course you want to have a detailed statistical design that allows you to test the hypothesis and potentially answer the question with valid endpoints. Por lo tanto, al diseñar un estudio, existen varios temas que deben considerarse, incluso antes de sentarse a escribir el estudio. Qué hipótesis se está intentando probar? Qué antecedentes científicos o clínicos respaldan esa hipótesis? Es necesario tener un esquema de tratamiento detallado. Cómo se tratará a los pacientes? Con qué frecuencia tendrán que venir? Cuándo se repiten los análisis? Cuáles son esos análisis? Qué sucede si se observa toxicidad, si el conteo sanguíneo es demasiado bajo o si el paciente desarrolla llagas en la boca? Cuánto tiempo se deja pasar antes de tratarlos nuevamente? Cómo se modifica la dosis? Si se administran varios fármacos, qué dosis se modifica? Se deben evaluar todas estas consideraciones antes de presentar el estudio para su revisión. Como ya he mencionado, es sumamente importante determinar cuáles serán los criterios de valoración. También debe describirse cuidadosamente cuál va a ser la población a tratar en el estudio. Y, por supuesto, se debe contar con 5

6 Types of Cancer Trials Phase 1: Focus on safety, pharmacokinetics, defining optimal drug dosing and schedule; obtain preliminary evidence for biological activity of an agent/combination regimen; explore utility of bio-markers Phase 2: Define the level of biological activity (generally objective response rate) in a specific setting and a particular tumor type with a defined dose/schedule of anti-neoplastic agents Now turning to the different types of trials, these are --- these are trials that are obviously very relevant for cancer, but they are also relevant for other conditions. Phase 1 studies, or sometimes people use the term Early Stage Trials; their primary focus is on safety, defining the safety of a particular regimen, combination chemotherapy, new biological agents with standard therapies. What you are looking at here is, is it safe? What are the doses to be given? What are the schedules to be used? If you look at the pharmacokinetics. You hopefully will get some preliminary evidence for the biological activity of a drug and hopefully you will actually --- or combination. Hopefully you will actually receive real genuine benefit, but the primary focus is again: define safety. When you get to Phase 2 trials, you have, hopefully, defined the appropriate doses and schedules to move forward, so everybody could be treated in the same way. And in the Phase 2 setting you are looking at the evidence of biological activity of a particular strategy. Generally, certainly in anticancer therapies, we are looking at a response rate, the percentage of patients whose tumor shrinks to a certain level that will define biological activity. And we, of course, in the Phase 2 setting, are looking at this in a very specific setting, particularly tumor type. Meaning that, well, we would not just treat patients with breast cancer, we would treat patients with breast cancer that have received one prior regimen and there is a tumor that we measured on radiographic imaging, for example. So the patients have very similar characteristics, so that when you, at the end of the day, have a response rate, you could say this is the response rate in this specific setting. un diseño estadístico detallado que permita probar la hipótesis y potencialmente responder la pregunta con criterios de valoración válidos. En cuanto a los diferentes tipos de estudios, claramente son muy relevantes para el cáncer, pero también lo son para otras condiciones médicas. Los estudios de fase 1, que también se denominan estudios de estadio temprano; su enfoque principal es la seguridad, definir la seguridad de un régimen particular, quimioterapia combinada, o nuevos agentes biológicos con terapias estándares. Se intenta determinar si es un tratamiento seguro. Las dosis que deben administrarse. El cronograma que debe utilizarse. Si se observa la farmacocinética, con suerte se podrá obtener alguna evidencia preliminar de la actividad biológica de un medicamento o de una combinación de medicamentos. Es posible que se obtenga algún beneficio genuino, pero el enfoque principal es definir la seguridad. Cuando se llega a los estudios de fase 2, se espera haber definido las dosis y los cronogramas de dosificación apropiados para seguir adelante y que todos los pacientes puedan ser tratados de la misma manera. En un estudio de fase 2 lo que se busca es evidencia de la actividad biológica de una estrategia en particular. Por lo general, especialmente en las terapias contra el cáncer, se analiza la tasa de respuesta, el porcentaje de pacientes cuyos tumores reducen su tamaño hasta un cierto nivel. Esto definirá la actividad biológica. En el contexto de los estudios de fase 2, esto se analiza en un entorno muy específico, particularmente el tipo de tumor; lo que significa, por ejemplo, que no solo trataríamos pacientes con cáncer de mama, sino que trataríamos pacientes con cáncer de mama que ya han recibido un tratamiento anterior y que tienen un tumor que hemos medido en imágenes radiográficas. De este modo, los pacientes tienen características muy similares, por lo que tendríamos una tasa de respuesta, y podríamos decir que ésa es la tasa de respuesta en este contexto específico. 6

7 Types of Cancer Trials Phase 3: Randomized comparison of an experimental regimen to a standard option; variable endpoints, including overall survival, progression-free survival, response rate, reduced toxicity, improved quality-of-life Phase 4: Post-marketing evaluation of efficacy and/or toxicity in the general population If Phase 2 data are promising, what we will then do to really find evidence of benefit of a new treatment is to do a randomized comparison of some experimental strategy to a standard treatment option. This is known as the randomized Phase 3 Trial. There can be variable endpoints. They can include: overall survival, progression-free survival, response rate, reduced toxicity, improved quality of life. But again, it is a comparison of one particular treatment to a standard option to see if the experimental option, whatever it may be, is superior or may be equally effective, but, for example, less toxicity is observed. And finally, after a particular regimen has been shown to be effective, and often the parlance here is the drug is approved by the FDA, but the question is: What is the toxicity observed and the efficacy observed when you are outside of the very well- defined patient populations of certain characteristics? So what happens when you get it into the community and you are treating patients who might be older or who have comorbid medical conditions? They might have heart disease or kidney disease in addition to their cancer, so what happens in the community setting? Such trials are often referred to as Phase 4 studies. Si los datos de la fase 2 son prometedores, con el fin de hallar evidencia del beneficio de un nuevo tratamiento realizaremos una comparación aleatoria de una estrategia experimental con una opción de tratamiento estándar. Esto se conoce como estudio de fase 3 aleatorizado. Puede haber criterios de valoración variables, que pueden incluir: supervivencia general, supervivencia libre de progresión, tasa de respuesta, reducción de la toxicidad, mejoramiento de la calidad de vida; sin embargo, es una comparación de un tratamiento particular con una opción de tratamiento estándar que tiene como fin determinar si la opción experimental, cualquiera que sea, es superior o igualmente eficaz, pero es posible observar menos toxicidad. Finalmente, después de que un régimen particular ha demostrado ser eficaz, y a menudo lo que se busca es que el fármaco sea aprobado por la Administración de Alimentos y Medicamentos (FDA), la pregunta sigue siendo: cuál es la toxicidad y la eficacia observadas cuando se administra fuera de las poblaciones de pacientes bien definidas y de determinadas características? Qué pasa cuando se le hace disponible a la comunidad y se trata a pacientes que podrían tener más edad o condiciones médicas comórbidas? Podrían tener una enfermedad cardíaca o renal, además de cáncer, de modo que qué pasa en el contexto comunitario? Este tipo de estudios a menudo son denominados de fase 4. 7

8 Necessary Resources Patients Clinical investigators Research nurses, data managers, pharmacists Data processing/storage Biostatistician expertise Administrative support Clinical and laboratory support facilities In the context of clinical trials, there are a number of critically important elements. Of course there are the patients, clinical investigators, research nurses, data managers, pharmacists that is certainly the case in drug cancer --- in drug studies. We have to figure out how to process the data; store the data. We clearly have to have biostatistical support to allow this trial to be properly run and properly analyzed. And, of course, administrative support as well as clinical and laboratory support facilities for the conduct of a trial. En el contexto de los estudios clínicos existe una serie de elementos de importancia crítica. Los pacientes, los investigadores clínicos, las enfermeras de investigación, los gerentes de datos, los farmacéuticos que ciertamente es el caso en los estudios de medicamentos contra el cáncer. Debemos determinar cómo procesar y almacenar los datos. Es necesario contar con apoyo bioestadístico que permita que el estudio sea ejecutado y analizado correctamente; además de apoyo administrativo, e instalaciones de apoyo clínico y de laboratorio para conducir el estudio. Ethical Principles of Clinical Research Autonomy: Patient must freely elect to participate in the trial Beneficence: Potential benefit associated with participation Non-maleficence: The risk of possible harm from participation must be acceptable based on the realistic potential for benefit Justice: Conduct of the trial must be fair and not exclude a patient population based on non-clinical considerations Turning to the critically important issues of the ethics of clinical research, these are briefly outlined on this slide. And I cannot emphasize enough the importance of the conduct of ethical research. And in the case of clinical research, while all of the items listed on the slide are important, the single most important issue is that of the ethical principle of autonomy. And that means, very simply, the patients must freely, and I have to emphasize the word freely or voluntarily, elect to participate in the trial. Coercion is not acceptable in anyway. The patients must be given information that allows them to make a free and voluntary decision to participate in the trial. Clinical research is not the same thing as clinical care. Clinical care is provided to patients with serious conditions. Of course, informed consent is required there as well, but a patient has to be told that clinical research is voluntary. Although the patient --- purpose of that research may, of course, be to help the patient, there is also information being generated and gathered in the conduct of that trial. And the patient needs to be informed and they need to be informed of the issues that are En cuanto a los temas de importancia crítica de los principios éticos de la investigación clínica, se describen brevemente en esta diapositiva. No puedo enfatizar lo suficiente la importancia de conducir una investigación ética. En el caso de la investigación clínica, si bien todos los elementos enumerados en la diapositiva son importantes, el tema más importante es el del principio ético de la autonomía. Esto significa que los pacientes deben decidir libremente y debo destacar la palabra libre o voluntariamente participar en el estudio. La coerción no es aceptable de ninguna manera. Los pacientes deben recibir información que les permita tomar la decisión libre y voluntaria de participar en el estudio. La investigación clínica no es lo mismo que el cuidado clínico. Se proporciona cuidado clínico a los pacientes con condiciones médicas graves. En ese caso, también se requiere un consentimiento informado, pero se le debe informar al paciente que la investigación clínica es totalmente voluntaria. Si bien el objetivo de esa investigación puede ser ayudar al paciente, también se genera y recopila información con la conducción de dicho 8

9 additional, in other words, extra biopsies that are obtained and extra tests that are done. They need to be given all of this information. What are the known risks associated with the research, or lack of knowledge of the particular side effects of an agent? That is what you are trying to learn. The patients need to be told all of this information and then must make an informed, but voluntary, choice. Beneficence is another important principle. Of course, it is important that physicians, in particular, but of course, all members of the healthcare team, understand that there needs to be some potential benefit to the patient. Or at least there is no evidence that we know that they will be more harmful, that is the non-maleficence. We must be concerned about the risk of harm and make sure that that risk is acceptable and realistic relative to the potential benefit. And the final principle is that of justice. The conduct of the trial must be fair and critically not exclude a patient population based on non-clinical considerations. For example, I think today one would say excluding individuals who are elderly, simply because they are elderly, is unacceptable. Or other, again, non-clinical considerations should not be used in making decisions whether individuals should or should not be given the opportunity to participate in the clinical trial. estudio. Se debe informar al paciente sobre los aspectos adicionales, es decir, las biopsias adicionales que deben obtenerse y las pruebas adicionales que deben realizarse. Deben recibir toda esta información. Cuáles son los riesgos conocidos asociados con la investigación, o la falta de conocimiento respecto a los efectos secundarios específicos de un agente? Esto es justamente lo que queremos conocer. Los pacientes necesitan recibir toda esta información y luego tomar una decisión informada, pero voluntaria. La beneficencia es otro principio importante. Es importante que los médicos en particular, y todos los miembros del equipo de cuidado de la salud comprendan que debe haber algún beneficio posible para el paciente. O al menos no debe haber evidencia conocida de que sea más perjudicial, que es el principio de no maleficencia. Debemos preocuparnos por el riesgo de perjuicio y asegurarnos de que ese riesgo sea aceptable y realista en relación con el beneficio posible. El último principio es el de justicia. La conducción del estudio debe ser justa y desde un punto de vista crítico no puede excluir a una población de pacientes a partir de consideraciones de naturaleza no clínica. Por ejemplo, creo que hoy en día se podría decir que excluir a personas de edad avanzada sólo porque son personas mayores es inaceptable. No se deben evaluar consideraciones que no sean clínicas al decidir si los individuos deben o no tener la oportunidad de participar en un estudio clínico. 9

10 IRB Review Responsible for ensuring ethical conduct of human subjects research Informed consent document states in clear language: (a) the purpose of the study; (b) how the study is being performed; (c) potential risks; and (d) available alternative options The document also informs patients of their rights, and who they may contact for concerns related to the study or their treatment program Reporting Clinical Trial Results Peer-reviewed publications Abstracts (national/regional meeting) IRB NCI, FDA, sponsoring company Clinicaltrials.gov One of the ways to ensure the ethical conduct of research is to have independent review of those research projects. And that is generally done by what are known as institutional review boards, sometimes they are called institutional review committees. These groups are responsible for ensuring the ethical conduct of human subjects research. One of the things they do, of course, is responsible for approving an informed consent document that clearly states in clear language, understandable to the research subjects, the potential research subjects, the purpose of the study, how the study is being performed, potential risks, and, critically important, available alternative options. Because if there are options, meaning there are standard drugs that might be considered, these options must be discussed with the patient. The document, the informed consent document also needs to inform the patients of their rights and who they may contact for concerns related to the study or the treatment program. And when the trial is completed, there are ways to disseminate the information. And this is a critical part of the trial and is also part of the ethics of the trial. You inform a patient they are going to be participating in research to generate knowledge that will help future patients. The way that knowledge is disseminated is obviously through a variety of strategies including peerreviewed publications, abstracts that are presented at national/regional meetings, obviously the IRB needs to be informed of this. In the case of cancer trials, of course, often sponsorship for many of these trials comes from the National Cancer Institute. Drug studies or device studies are often under the review of the FDA. And, of course, there is a sponsoring company that will get this information and critically important, that the results of trials be presented in public databases such as clinicaltrials.gov. That is the way the public will know that these trials have been conducted and the results of Una manera de garantizar una conducción ética durante la investigación es contratar revisiones independientes para esos proyectos de investigación. Generalmente, esta tarea es realizada por juntas de revisión institucional, también denominadas comités de revisión institucional. Estos grupos son responsables de garantizar la conducción ética de la investigación con sujetos humanos. Son responsables de aprobar un documento de consentimiento informado que indique en un lenguaje claro y comprensible para los sujetos de investigación y los potenciales sujetos de investigación, el objetivo del estudio, cómo se realizará, los riesgos potenciales y las opciones alternativas disponibles. Si existen opciones, significa que existen medicamentos estándar que pueden considerarse, y estas opciones deben ser discutidas con el paciente. El documento de consentimiento informado también debe informar a los pacientes acerca de sus derechos y a quién pueden contactar por inquietudes relacionadas con el estudio o el programa de tratamiento. Una vez completado el estudio, hay maneras de difundir la información. Esta es una parte muy importante del estudio y también forma parte de sus principios éticos. Informamos a los pacientes que van a participar en una investigación con el fin de generar conocimientos que ayudarán a futuros pacientes. Para difundir este conocimiento se utilizan diversas estrategias que incluyen publicaciones revisadas por expertos, y resúmenes que se presentan en reuniones nacionales y regionales. La Junta de Revisión Institucional necesita tener conocimiento de todo esto. En el caso de los estudios de cáncer, a menudo el patrocinio para muchos de estos estudios proviene del Instituto Nacional del Cáncer. Con frecuencia, los estudios de medicamentos o de dispositivos se encuentran bajo la supervisión de la FDA. Hay una empresa patrocinadora que recibirá esta información y se ocupará de que los resultados de los estudios sean presentados en bases de datos públicas, como clinicaltrials.gov. De esta 10

11 Who Conducts Cancer? Single institution (single investigator or multiple) Several institutions (efforts focused on the conduct of a single clinical trial) Not-for-profit cooperative group (NCI-funded, CCOP) Pharmaceutical/biotech multi-institutional and (increasingly) multi-national efforts the trials will be freely available to the public. Now who is responsible for the conduct of the clinical trials? This can obviously include a single institution. It might even be a single investigator. It might be multiple institutions working together on a single trial. Then, of course, there are cooperative groups. In the cancer arena, there are groups that are funded by the National Cancer Institute and, of course, studies may be sponsored and run by pharmaceutical or biotech companies. These can even be multi-national efforts today. manera, el público se enterará de que se han conducido estos estudios y tendrán a su disposición los resultados. Quién es responsable de la conducción de los estudios clínicos? Esto puede incluir a una sola institución, a un solo investigador, o podrían ser múltiples instituciones trabajando juntas en un solo estudio. También están los grupos cooperativos. En el ámbito del cáncer, existen grupos que son financiados por el Instituto Nacional del Cáncer. Los estudios también pueden ser patrocinados y realizados por compañías farmacéuticas o de biotecnología. Actualmente, estos pueden ser incluso esfuerzos multinacionales. Conclusions Clinical trials are essential in identifying effective therapies and expanding the application of treatment strategies for various cancers Prospectively defined clinical endpoints may include response, time to disease profession, survival and quality-of-life factors Patients must be free to elect to participate in clinical trials and understand the potential risks and available alternatives So, in conclusion, it is important to state that clinical trials are essential in identifying effective therapies and in expanding the application of treatment strategies for various cancers. It is critical that these studies have prospectively defined clinical endpoints, and these can include response, time of disease progression, survival, as well as quality of life factors. And finally, and critically important, patients must be free to elect to participate in clinical trials and to understand the potential risks of participation as well as alternative strategies. I thank you for your attention and we would certainly be very interested in knowing if this presentation has been of value to you. And we hope that it has increased your understanding of both the need for clinical trials and the ethical conduct of clinical trials. Thank you very much. En conclusión, es importante señalar que los estudios clínicos son esenciales para identificar terapias eficaces y para expandir la aplicación de estrategias de tratamiento para los diversos tipos de cáncer. Es fundamental que estos estudios tengan potencialmente definidos los criterios de valoración clínicos, que pueden incluir respuesta al tratamiento, tiempo de progresión de la enfermedad, supervivencia y factores de calidad de vida. Por último, es muy importante que los pacientes tengan la libertad para elegir participar en los estudios clínicos, y para comprender los riesgos potenciales de su participación y las estrategias alternativas. Les agradezco su atención, y sin duda estaremos muy interesados en saber si esta presentación les ha resultado valiosa. Esperamos que les haya permitido mejorar su comprensión de la necesidad de realizar estudios clínicos y de su conducción ética. Muchas gracias. 11

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