Clinical research is conducted according to an action plan known as a Clinical Trial PROTOCOL. Clinical investigation begins with the development of a clinical protocol and writing a research proposal is one of the most challenging and difficult in clinical trials. What is a protocol? The protocol is a document that describes the action plan […]
Read More →Decentralized clinical trials (DCT)s, also known as “direct-to-participant trials,” “virtual” monitoring, or “remote clinical trials“, differ from conventional research studies. These clinical trials use telemedicine, sensory-based technology, home visits, wearable medical devices, patient-driven virtual health care interfaces, direct drug and material delivery to patients’ homes, neighborhood labs, digital consent data gathering, remote monitoring, and diagnostics […]
Read More →Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions and now in clinical trial designs. The gold standard for demonstrating the efficacy of clinical trials since the 1960s has been randomized controlled trials (RCTs). We require at least two pivotal RCTs on the market for investigational medications. RCTs […]
Read More →Sponsors, Contract Research Organizations (CROs), and sites have adopted Electronic Data Capture (EDC) systems to carry out both simple and complex clinical trials in all phases of clinical research. Clinical trials are moving toward using EDC software, replacing paper records with electronic records. Traditionally, researchers were to use paper-based forms, which in a few cases, […]
Read More →Sponsors and CROs are preparing to conduct more hybrid clinical trials than traditional site-based trials, marking a turning point for the industry. A poll found that 77 percent of clinical trial executives planned to perform hybrid trials next year, up from 59 percent the year before. Hybrid clinical trial models have their roots in decentralized […]
Read More →The clinical research landscape is shifting drastically due to an increase in the availability of electronic data allowing researchers to make assessments based on available real-world evidence (RWE) obtained from the analysis of real-world data (RWD). Global regulators are encouraging researchers/drug developers utilize the RWE for submissions. Many regulators are accepting the Real-world evidence (RWE) […]
Read More →Clinical biostatistics play a crucial role in the drug development process right from trial design to protocol development. Biostatistics finds applications in various fields such as epidemiology, clinical trials, population genetics, systems biology, and more. Biostatistics is critical to collect, analyse, present, and interpret data in clinical research. it helps in making decisions regarding the […]
Read More →An electronic informed consent (eConsent or eICF) is a principle in clinical research that a patient should have sufficient information before making their own free decisions about their medical care and participate in clinical research. Using electronic medium to manage informed consents makes the researchers job easy and regulatory authorities also recommend using eICF. Did […]
Read More →Designing clinical trials in psychiatry is challenging compared to a regular clinical trial. Clinicians and instructors have to handle participants who are mentally ill. They have to assume numerous factors before the clinical trial, where the main issue is taking informed consent, populations, measuring end-points, etc. There are many ethical laws and criteria for designing […]
Read More →The eTMF (Electronic Trial Master File) plays a crucial role in clinical trials and ensures that the trial has been managed successfully by the sponsor, investigators, and the Institution. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) developed initiatives to use technology that could help both expedite the […]
Read More →