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Clinical Research

Essential Components and Glossary in Clinical Trials

December 17, 2020Category : Clinical Research

New tests and treatments aren’t offered to the public as soon as they’re made. They need to be studied. A clinical trial is a type of research that studies a test or treatment given to people. Clinical trials study how safe and helpful tests and treatments are. Clinical research is how we develop new treatments and knowledge..

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The Imperative Role Of Good Clinical Practice Guidelines (ICH- GCP) In Clinical Trials

September 13, 2020Category : Clinical Research

Clinical research is crucial in determining the safety and efficiency of medication and other healthcare practices intended to be used on human beings. Clinical research is imperative to society since studies add to general medical knowledge. Most of what we know today came to light because of medical research devised to answer important scientific and health..

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Get Ahead In The Medical Profession- Time To Upgrade Your Skills

September 2, 2020Category : Clinical Research

From a rapidly ageing population, to the anti-vaccine movement and non-communicable diseases, healthcare is facing major challenges all over the world. We have no idea what the rapid technological development, the so-called fourth industrial revolution will bring upon us in the next decades. There is only one certainty: we will need a new set of skills to..

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Basic Pharmacology And Physiology Of Anti-Inflammatory Drugs

August 16, 2020Category : Clinical Research

More than 20 different nonsteroidal anti-inflammatory drugs (NSAIDs) are available commercially, and these agents are used worldwide for their analgesic antipyretic and anti-inflammatory effects in patients with multiple medical conditions. NSAIDs, including aspirin, do not generally change the course of the disease process in those conditions, where they are used for symptomatic relief. Nonsteroidal anti-inflammatory drugs..

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Phase II clinical trials: Does the treatment work?

July 29, 2020Category : Clinical Research

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Once the initial safety of the study drug has been confirmed in Phase I..

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Phase I Clinical Trials: Is The Treatment Safe?

July 25, 2020Category : Clinical Research

The first step in testing an experimental drug (or other treatment) in humans. Clinical trials of medicines and biologicals typically proceed through ‘phases’ of development whereas clinical trials of medical devices are more appropriately represented by ‘stages Phase 1 trials evaluate the drug’s safety and toxicity at different dose levels and determine drug pharmacokinetics. Because little is known..

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Major Components and Definitions in Clinical Trials

July 20, 2020Category : Clinical Research

Clinical trials aimed to improve health and quality of life are the cornerstone of progress in medicine. Support comes from academic medical centers, philanthropy, the National Institutes of Health (NIH), industry, or combinations thereof. Medical research should always be patient-centered; thus, the patient is seated on the model chair of clinical research. The medical team comprises..

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Roles and Responsibilities of Clinical Research Associate (CRA) During Clinical Trials

July 16, 2020Category : Clinical Research

Clinical Research Associate also known as monitor is employed by either a pharmaceutical company or a contract research organization (CRO) which works on behalf of pharmaceutical companies. CRAs are responsible for data collection and documentation as well as are often responsible for managing trial-related supplies and other research-related support tasks. The role of CRA is to ensure..

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Sponsor Responsibilities Under Good Clinical Practice Guidelines

July 11, 2020Category : Clinical Research

A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. Any delegation of responsibilities to another party should be formally agreed and documented by the sponsor. Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor’s staff should lead..

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Primary Roles and Responsibilities of Institutional Ethics Committee (IEC/IRB) during Clinical Trials

July 7, 2020Category : Clinical Research

In making decisions about health care, patients, families, and physicians and other health care professionals often face difficult, potentially life-changing situations. Such situations can raise ethically challenging questions about what would be the most appropriate or preferred course of action. Institutional Ethics committees (IEC), or Institutional Review Board (IRB), offer assistance in addressing ethical issues that arise..

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