Clinical trialshelp test new methods or drugs or devices for diagnosis, prevention or treatment of various health conditions or diseases. Clinical trials are conducted to understand the safety and efficacy of a new drug or device that undergoes different stages of approval before it is sold in the market. The extensive research for the drug or device involves years of experimentation in animals and humans. The experimental drug or device is subjected to human testing which consists of four phases. After completion of each phase which is considered a separate trial, the investigators submit their results or data to national authority for approval before starting with the next phase.
What is the role of quality in clinical trials?
Clinical trials provide information on the safety and efficacy of drugs under study. Sponsors of the clinical trial ensure that the investigators are following the compliant protocol and collecting and reporting quality data. Quality, one of the core modules of the trial, can be defined as a set of characteristics that a product or service must possess in order to meet the requirements of the customer. Quality management system in clinical research aims at establishing and consistently achieving compliance with ethical, regulatory and GXP standards and maintaining authenticity of the clinical data. Quality control and quality assurance are the standard components of the quality management system in clinical research.
Why is monitoring required?
Monitoring is mandated by the Food and Drug Administration (FDA) in order to validate the integrity of the clinical trial. In general, this process is hugely personnel-intensive and involves site visits to inspect personnel, facilities, equipment, processes and documentation. It has been estimated that one third of the budget of the trial is spent on on-site monitoring. In an effort to minimize the time and costs involved in this process, the contract research organizations (CROs) emerged to support this task with virtual workspaces. These cost-effective remote strategies resulted in saving upto 70% of the resources spent on trials.
The most challenging task of a clinical trial is the recruitment of potential participants. Enrolling candidates in the trial involves a lot of obstacles that include limited knowledge on trials, concerns regarding deviating from standard care protocols, uncertainties in the process and personal hurdles. Also, there could be an intense competition among the candidates to participate in the trial in case of pharmaceutical products. In order to resolve these issues, there should be a proper marketing and communication plan to attract participants and motivate them to enrol in the trial. This has become quite simpler in the era of internet with online marketing strategies.
Training in Clinical Trial Management :- Clinical research comprises of testing and ascertaining the safety and efficacy of new unapproved health care products, including medical devices, biologics, and pharmaceuticals in human subjects. Clinical trials in human subjects are a pre-condition for marketing approvals, by local regulatory authorities such as the U.S. Food and Drug Administration (FDA). Continue reading
What are the key tasks of a Clinical Research Associate in Clinical Trial experiments?
CRA Training :- A CRA (Clinical Research Associate) is responsible in design, scheduling, preparation, execution and review of a clinical trial experiment to guarantee it that it sticks to regulatory and ethical guidelines. CRA’s also play a key role in data exchange with all the stake holders. Continue reading