
Isis Clinical Research Center
Health Innovations
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What is a Clinical Trial?
A clinical trial is a research study conducted by medical professionals to assess the safety, efficacy, and potential side effects of a new medical treatment, intervention, or procedure. It is an essential step in the process of bringing new medications, therapies, or medical devices to the market and improving patient care.
Phases of a Clinical Trial
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Description text gBefore a clinical trial begins, extensive laboratory research is conducted, typically involving animal models or in vitro studies. These preliminary investigations help evaluate the safety and effectiveness of the new treatment or intervention.oes here
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This initial phase focuses on a small group of healthy volunteers or individuals with specific medical conditions. The primary goal is to determine the safety, dosage, and potential side effects of the treatment under investigation. Phase I trials help researchers establish the appropriate dosage range for subsequent phases.
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In this phase, researchers expand the number of participants, often including individuals who have the targeted medical condition. The primary objective is to assess the effectiveness of the treatment and further evaluate its safety. Phase II trials provide valuable information about the treatment's potential benefits and potential side effects.
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This phase involves a larger group of participants who have the specific medical condition targeted by the treatment. Phase III trials compare the new treatment to existing standard interventions or placebos. These trials aim to determine the treatment's overall safety, efficacy, and any potential side effects in a larger population. Phase III trials provide robust evidence of the new treatment's effectiveness before it can be approved for widespread use.
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Once a treatment has been approved by regulatory authorities, post-marketing surveillance studies, or phase IV trials, may be conducted. These trials monitor the treatment's long-term safety and effectiveness, as well as potential rare side effects that may not have been observed in the earlier phases.Throughout these phases, clinical trials follow strict ethical guidelines designed to protect the rights, safety, and welfare of the participants. Independent review boards or ethics committees meticulously review and approve the study protocols to ensure the research is conducted responsibly.Participating in a clinical trial is entirely voluntary, and individuals and choose to opt-out freely
Do We Need Hormonal Screening In Patients With Subcentimeter Pituitary Microadenomas?
José Hernán Martínez-Méndez, Madeleine Gutiérrez-Acevedo, Coromoto Palermo-Garofalo, María de Lourdes Miranda-Adorno, Michelle Mangual-García, Alfredo Sánchez-Cruz, Carmen Rivera-Anaya, Paola Mansilla-Letelier, Ivan Laboy-Ortiz Bol Asoc Med P R 2015 Apr-Jun;107(2):89-91.
Research Publications
Young female with acromegaloid features and pituitary macroadenoma: what is your diagnosis?
José Hernán Martínez, Carlos Figueroa-Núñez, Paola Mansilla-Letelier, Coromoto Palermo-Garofalo, Mónica Santiago, Oberto Torres, Rafael Trinidad, Michelle Mangual-García, Alfredo Sánchez, Madelin Gutierrez, María de Lourdes Miranda, Eva González Bol Asoc Med P R 2014;106(1):49-53.
A middle aged woman with isolated ACTH deficiency associated with transient growth hormone deficiency
Hernán Martínez J, Mangual Garcia MM, Gutiérrez Acevedo M, Sánchez Cruz A, Laboy I, Rivera C, Mansilla P, Palermo Garofalo C, Lourdes Miranda M, Torres Rafael O.Bol Asoc Med P R. 2016;108(1):5-8.
Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes
Juan P Frías 1, Melanie J Davies 1, Julio Rosenstock 1, Federico C Pérez Manghi 1, Laura Fernández Landó 1, Brandon K Bergman 1, Bing Liu 1, Xuewei Cui 1, Katelyn Brown 1; SURPASS-2 Investigators N Engl J Med
Secondary Resistance to dopamine agonist after thirteen months of successful treatment in a 42 years old man
Iván E Laboy-Ortiz, Sharon Velez-Maymí, José Hernán Martínez, Rafael Trinidad, Michelle Mangual, Alfredo Sanchez, Madeline Gutierrez, Paola Mansilla, Carmen Rivera, Coromoto Palermo, María Lourdes Miranda, Ricardo BrauBol Asoc Med PR.2016;108(10066):29-34.
Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial
Ania M. Jastreboff, M.D., Ph.D., Lee M. Kaplan, M.D., Ph.D., Juan P. Frías, M.D., Qiwei Wu, Ph.D., Yu Du, Ph.D., Sirel Gurbuz, M.D., Tamer Coskun, M.D., Ph.D., Axel Haupt, M.D., Ph.D., Zvonko Milicevic, M.D., and Mark L. Hartman, M.D. for the Retatrutide Phase 2 Obesity Trial Investigators*N Engl J Med 2023; 389:514-526
Research Trials
If you want to contribute to science and be part of a clinical trial, contact us!
“Whatever it is, the way you tell your story online can make all the difference.”
Paola Mansila Letelier, MD
