Research in humans takes a cautious and progress in a sequential or phase approach. Back to Top. Clinical trials may either be interventional or observational clinical trials. Interventional clinical trials involve giving a participant a particular treatment in accordance with a research plan. Usually, these participants are compared to subjects who receive no treatment or standard treatment. Observational clinical trials involve giving a participant a particular treatment in accordance with clinical practice.
Introduction to Clinical Research Training Program
Clinical trials are designed to improve medical knowledge related to the treatment, diagnosis and prevention of illnesses. Clinical trials translate results from basic scientific research and promote an evidence-based approach to healthcare leading to better health outcome.
The results of clinical trials can make a difference in the care of patients by providing information about the benefits and risks of new therapeutic, preventative, or diagnostic products or interventions. Clinical trials also can contribute invaluable information about the benefits and safety of existing therapies, providing doctors and patients with reliable information for choosing between alternative treatments.
Clinical trials are an essential part of the regulatory process. They provide the basis for the development and marketing of new drugs, biological products, and medical devices.
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The data collected from clinical trials to provide the evidence to show that the product is safe and effective is used to support product registration or marketing authorisation of new medicines and medical devices. The system of regulation requires that Principal Investigators PI conducting clinical trials to obtain both ethics and regulatory approvals before initiating a study. In order to receive regulatory approval from HSA to conduct clinical trials here, companies must provide relevant evidence that the investigational drug is acceptably safe and the design and conduct of the trial provide adequate levels of protection for participants.
A clinical trial is conducted in accordance with a research plan called a protocol that has been designed to address the research question and safeguard the rights, safety and well-being of participants. The protocol outlines the eligibility criteria thereby defining the population being researched upon for the clinical trial. The eligibility criteria usually define the age, gender, type and stage of an illness, previous treatment history, and other medical conditions.
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Participants must sign an informed consent form before they can be screened for eligibility assessment for a clinical trial. Who can conduct a clinical trial? A clinical trial is conducted by an Investigator who must be a locally registered doctor or dentist. In Singapore, clinical trials are usually conducted by senior doctors or specialists in their field of practice, and performed in hospital settings.
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The Investigator usually works together with a team of healthcare professionals like doctors, nurses and pharmacists to conduct the clinical trial. Clinical trials can be sponsored by pharmaceutical companies, medical technology companies, biotechnology companies, hospitals and other funding bodies.
A clinical trial is usually conducted at hospitals or clinics. The location depends on who is conducting the clinical trial. The study team will check the health of the participant and screen the participant based on the eligibility criteria outlined in the research plan or protocol. A participant who is found to be eligible will be enrolled into the clinical trial and study procedures will be conducted on the participant in accordance with the protocol.
Depending on the trial, participants may be distributed into different treatment groups. In a controlled trial, the trial group will be given the new study treatment while the other control group will be given an existing or standard treatment. In cases where there are no standard or existing treatments, a control group may be given a dummy treatment called a placebo. Participants are allocated to random groups to ensure each group has a mix of participants to reflect the requirements of the trial.
Constant communication between the participants and trial team is vital would ensure the safety and proper conduct of the clinical trial. At the end of the trial, the results should be made known to everyone so that participants will be able to obtain information and make decisions for their well-being.
The length of a clinical trial depends on what is being researched upon. Participants are informed about the duration of participation in the clinical trial during the informed consent process. What are some of the possible risks of participating in a clinical trial? Clinical trials are designed to minimise the risks to all participants.
While some risks are unavoidable because of the uncertainty inherent in medical research studies involving new treatments, the ethical and regulatory review together help to ensure that the specific aims, problems and risks or benefits of a particular clinical trial are thoroughly considered and that the chosen options are scientifically sound and ethically justified.
Participating in a clinical trial may be demanding and time consuming. All potential participants are strongly encouraged to learn as much as possible about clinical trials and understand the benefits and risks associated before participating. Clinical Researcher Voices from the field, expert advice, and peer-reviewed articles.
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