Kresnier Perez

Double blind randomized controlled trials (DBRCTs) are considered the gold standard in clinical research, particularly in the evaluation of new medical interventions. These trials are designed to eliminate bias and ensure that the results are as reliable and valid as possible. In a DBRCT, neither the participants nor the researchers know which individuals are receiving […]

Noninferiority trials have emerged as a pivotal methodology in clinical research, particularly in the realm of drug development and therapeutic interventions. These trials are designed to demonstrate that a new treatment is not worse than an existing treatment by a pre-specified margin, known as the noninferiority margin. This approach is particularly valuable in situations where

The Credence Trial, formally known as the Canagliflozin and Renal Events in Diabetes and Nephropathy Trial, represents a significant advancement in the field of diabetes management, particularly concerning the treatment of patients with type 2 diabetes and chronic kidney disease (CKD). Launched in 2013, this large-scale, multicenter, randomized controlled trial aimed to evaluate the efficacy

Clinical Data Management Systems (CDMS) are pivotal in the realm of clinical research, serving as the backbone for data collection, management, and analysis throughout the lifecycle of clinical trials. These systems are designed to facilitate the efficient handling of vast amounts of data generated during clinical studies, ensuring that the information is accurate, secure, and

Clinical trials are a cornerstone of medical research, serving as the primary method for evaluating the safety and efficacy of new treatments, drugs, and medical devices. These trials are meticulously designed studies that involve human participants and are governed by strict regulatory frameworks to ensure ethical standards and scientific integrity. The process of conducting clinical

Clinical Data Management Systems (CDMS) play a pivotal role in the realm of clinical research, serving as the backbone for data collection, management, and analysis. These systems are designed to facilitate the organization and storage of clinical trial data, ensuring that it is both accurate and accessible. The primary function of a CDMS is to

The Topaz 1 Trial represents a significant advancement in the realm of clinical research, particularly in the treatment of certain malignancies. This trial is part of a broader effort to explore innovative therapies that can enhance patient outcomes and provide new hope for those battling cancer. Conducted with a diverse cohort of participants, the Topaz

Tirzepatide is a novel medication that has garnered significant attention in the field of diabetes management, particularly for its dual-action mechanism that targets both glucose-dependent insulin secretion and appetite regulation. Developed by Eli Lilly and Company, this medication is a synthetic peptide that mimics the action of two incretin hormones: glucagon-like peptide-1 (GLP-1) and glucose-dependent

The Electronic Trial Master File (ETMF) system represents a significant evolution in the management of clinical trial documentation. Traditionally, the Trial Master File (TMF) was a physical collection of essential documents that provided evidence of the conduct of a clinical trial and the integrity of the data generated. However, as the clinical research landscape has

Clinical trials are pivotal in advancing medical knowledge and treatment options, particularly in the realm of oncology. At the heart of these trials is the Principal Investigator (PI), a key figure responsible for overseeing the study’s design, implementation, and adherence to regulatory standards. The PI ensures that the trial is conducted ethically and that the