Clinical Trials | Are Clinical Trials safe? What are the Safety Measures of Clinical Trials?Are Clinical Trials safe? What are the Safety Measures of Clinical Trials? Introduction In a clinical trial, the safety and well-being of the volunteer participants is paramount. All researchers, investigators and healthcare workers involved in the clinical study must ensure that the risks of a trial do not outweigh its benefits. Participant inclusion and exclusion
Clinical Trials | What are Clinical Trial Phases?What are Clinical Trial Phases? Introduction Clinical trials are conducted in four or more different phases to evaluate an investigational new drug (IND) and its effect on human health. Through these phases, the drug is discovered, the disease needing treatment is identified, and finally, the drug is submitted for regulatory approvals and launched for sale Phase 1 TrialPhase 2 TrialPhase 3 TrialPhase 4 Trial (PMS)
Clinical Trials | Clinical Trial Methods – Quantitative / Qualitative Clinical ResearchWhat is Clinical Trial Method? Introduction Clinical trial methods integrate strategies to achieve valid conclusions about trial objectives and safeguard participants, utilizing both quantitative and qualitative research approaches. Emphasising the significance of statistical reasoning in clinical research, a clinical trial method is integral to the methodology of clinical trials. Therefore, understanding the various types of
Clinical Trials | What Are the Technology Solutions for Clinical Trials?What Are the Technology Solutions for Clinical Trials? Introduction Technological solutions continue to foster medical research, especially the clinical trial approach. Much like the impact it has had on our daily lives, digital technology has significantly revolutionised the medical research landscape. Introducing technologies into clinical trials has influenced them in numerous ways, such as bringing
Clinical Trials | What is a Clinical Trial Treatment?What is a Clinical Trial Treatment? Introduction A clinical trial or a clinical trial treatment involves researching to examine the effects of new tests and treatments on human health outcomes. Clinical trial treatments, as well as clinical trials in general, go through meticulous design, thorough review, and rigorous approval processes before initiation. When conducted with
Clinical Trials | Difference between Clinical Trial and Clinical StudyDifference between Clinical Trial and Clinical Study Summary Clinical studies and clinical trials are both types of clinical research. Clinical research aims to study research findings and help translate them in treating patients for various diseases. It comprises different types of clinical studies all of which involve human participation. Clinical studies are a broader category Clinical Study Report
Clinical Trials | Role of a CRO in Medical Device Clinical InvestigationsRole of a CRO in Medical Device Clinical Investigations Clinical investigations are essential for assessing the medical device safety and efficacy before they are launched in the market. Regulatory bodies like the CDSCO and CLA oversee clinical investigations in India. CRO for medical device plays a crucial role in conducting clinical investigations offering expertise in Clinical Investigation of a Device
Clinical Trials | From RCT to BCT: How Big Data is Transforming the Clinical Trials LandscapeHow big data is transforming the clinical trials landscape Currently, Randomized Controlled Trial (RCT) is the gold standard of clinical research, but with caveats. Translating biological efficacy into clinical efficacy is a major hurdle. Since RCTs are conducted in strictly monitored environments and even stricter guidelines, their implementation in real-world healthcare situations falls short of BCTClinical ResearchClinical TrialsRCT
Clinical Trials | Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for SponsorsUnlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors Introduction RWE studies and randomised controlled trials (RCTs) should ideally work together to further explore and offer deeper insights into product effectiveness and safety in particular patient subgroups, such as those with comorbidities. Overview of Real-World Evidence in Clinical Studies Real
Clinical Trials | Understanding the Importance of Real-World Evidence (RWE) in Clinical Trial SolutionsUnderstanding the Importance of Real-World Evidence (RWE) in Clinical Trial Solutions Introduction The process of obtaining data on a treatment’s actual effectiveness from medical records and other sources is known as real-world evidence or RWE. RWE can help researchers make more informed decisions about which therapies to make available by helping them comprehend practical results