clinical trials definition

Some even look at ways to prevent diseases from happening. The goal of this effort is to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. They also try to figure out the side effects it may cause. They also try to figure out the side effects it may cause. Studies that involve secondary research with biological specimens or health information are not clinical trials. Clinical trials may investigate the effectiveness of new drug treatments, new combinations of drugs, surgical procedures, or … These FAQs further clarify the application of the clinical trial definition. This is the last phase of testing the drug needs to complete before the drug information and clinical trial results are submitted to the regulatory authorities for approval of the drug for use in the general populat… A clinical trial tests (or tries out) an intervention -- a potential drug, medical device, activity, or procedure -- in people. Cancer clinical trials test new treatments in people with cancer. The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical … Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. In these studies, experimental drugs in the later stages of clinical trials are offered to people who don't qualify for the clinical trials. But before we dig into specifically how it does that, let’s review some terms commonly referred to when discussing eCOA: Some investigations look at how people respond to a new intervention* and what side effects might occur. Clinical trials are carefully conducted tests in which effectiveness and side effects are studied, with the placebo effect eliminated. What can be done to Promote Research Integrity? The difference between NIH’s Definition of a Clinical Trial (CT) and what FDA will consider a CT under the requirements of its Investigational New Drug (IND) or Device Exemption (IDE) Process affects a small number of NIH applications proposing certain types of research. For example, two-by-two cross-over assignment involves two groups of participants. Clinical trials used in drug development are sometimes described by phase. An experimental design used for testing the effectiveness of a new medication or a new therapeutic procedure. In 2014, NIH’s definition of a clinical trial was revised in anticipation of stewardship reforms. Such studies seek to establish optimal dosage and route of administration and to detect adverse reactions. Clinical trials are a form of clinical research that follow a defined protocol that has been carefully developed to evaluate a clinical question. A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. RCT is the most accepted scientific method of determining the benefit of a drug or a therapeutic procedure. Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. to one or more interventions interventionsAn "intervention" is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial? After phase 2, the drug enters the most vital stage of its development, the phase 3 trial. Your human subjects study may meet the NIH definition N/A: Trials without phases (for example, studies of devices or behavioral interventions). a controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention. A clinical trial is one of two main types of clinical studies. Principal Investigator. To find out if a drug is … clinical trial Clinical medical trial, clinical research trial Research A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or behavioral interventions. Clinical trial definition is - a scientifically controlled study of the safety and effectiveness of a therapeutic agent (such as a drug or vaccine) using consenting human subjects. All new drugs undergo clinical trials before approval. Many of these words are also used by clinical researchers and others in the same or a similar manner. This glossary will help you understand words and phrases frequently used on ClinicalTrials.gov. Most IRB… A controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention. In phase 2, the drug's efficacy and optimal dosing regimen are established. Studies intended solely to refine measures are not considered clinical trials. Phase IV trials are conducted after a national drug registration authority (in the U.S., the Food and Drug Administration) has approved an agent for distribution or sale. Another way to get access to experimental treatments is through expanded access studies. The local ethics committee has discretion on how it will supervise noninterventional studies (observational studies or those using already collected data). Is the effect being evaluated a health-related biomedical or behavioral outcome? In 2014, NIH’s definition of a clinical trial was revised in anticipation of stewardship reforms. All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. An "intervention" is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. A clinical trial is a research study that finds new ways to prevent, diagnose or treat disease. Clinical trials are key to understanding the appropriate use of medical interventions of all types and informing payers about what services to cover. Glossary of Common Site Terms. Are the participants prospectively assigned to an intervention? They may explore specific pharmacologic effects, adverse reactions, or long-term effects. : international clinical trials regulations, U.S. Department of Health and Human Services, Select the right NIH funding opportunity announcement for your research study, Write the research strategy and human subjects sections of your grant application and contract proposal, Comply with appropriate policies and regulations, including registration and reporting in ClinicalTrials.gov. This definition includes Phase I to Phase IV trials. Print this decision tree for an easy reference for the four questions that identify a clinical trial. Phase III trials, often multicenter, involve thousands of volunteers, randomly assigned to control and study groups. This page provides information, tools, and resources about the definition of a clinical trial. of a clinical trial. The U.S. National Institutes of Health (NIH) defines a … Clinical trials are closely supervised by appropriate regulatory authorities. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. Definition of clinical trial : a scientifically controlled study of the safety and effectiveness of a therapeutic agent (such as a drug or vaccine) using consenting human subjects Examples of clinical trial in … Four phases of clinical trial are distinguished. Does the study involve human participants? The difference between NIH’s Definition of a Clinical Trial (CT) and what FDA will consider a CT under the requirements of its Investigational New Drug (IND) or Device Exemption (IDE) Process affects a small number of NIH applications proposing certain types of research. All studies involving a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial. A clinical trial, also known as a clinical research study, is a protocol to evaluate the effects and efficacy of experimental medical treatments or behavioral interventions on health outcomes. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies. health-related biomedical or behavioral outcomes.A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Clinical Trials: The study of human volunteers for the purpose of evaluating the safety and efficacy of a medical treatment. Clinical trials are a way to test new methods of diagnosing, treating, or preventing health conditions. See Drug discovery, IND, Phase I, II, and III studies. Later phase trials aim to test whether a new treatment is better than existing treatments.There are Correctly identifying whether a study is considered by NIH to be a clinical trial is crucial to how you will: In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. Clinical trials may also be referred to as interventional trials. These simplified case studies illustrate the differences between clinical trials and clinical studies. Your study does not have a comparison group (e.g., placebo or control), Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug, Your study is utilizing a behavioral intervention, Only one aim or sub-aim of your study meets the clinical trial definition, National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892. In phase 1 clinical trials, the safety, tolerability and toxicity of the drug at different doses is tested in a small number of healthy volunteers. Some people who are not eligible to participate in a clinical trial may be able to get experimental drugs or devices outside of a clinical trial through expanded access. Electronic Clinical Outcome Assessment (eCOA) is a method of capturing data electronically in clinical trials. Use the following four questions to determine the difference between a clinical study and a clinical trial: Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…. Before any new treatment is used with people in clinical trials, researchers work for many years to understand its effects on cancer cells in the lab and in animals. “As per the National Cancer Institute “In research, the process by which participants in clinical trials are assigned by chance to separate groups … The FDA defines decentralized clinical trials as those executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies. Another way to get access to experimental treatments is through expanded access studies. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. The NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial. (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. These treatments investigate promising new drugs, drug combinations, new approaches to surgery or radiation therapy, and advances in new areas such as gene therapy. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life. A research study in which one or more human subjects are prospectively assigned prospectively assignedThe term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial. Additional Actions IND Regulations of 1963 –Created the current framework of clinical trials –Investigations must be “adequate” and “well-controlled” These are pilot efficacy studies, with emphasis on immunogenicity in the case of vaccines, and on relative efficacy and safety in the case of drugs, procedures, and devices. The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial. Recently, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials with the goal to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a … Clinical trials: Trials to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. It represents the best evidence available, which is integrated into the final decision about the management of a condition by healthcare practitioners in what is called, As noted above, the final rule applies to applicable, Written by authors with considerable experience in this field, the book is an authoritative guide for clinicians, data managers and medical statisticians involved in, Komen for the Cure and the Claude Worthington Benedum Foundation are supporting the effort to build the cancer, All of these resources are devoted solely to conducting, In the medical field, the policy preceded a wave of new pharmaceuticals development, with almost 400 new therapeutic agents in, On the basis of type, the market has been divided into enterprise, Nonetheless, it is very important to create a publicly accessible, Dictionary, Encyclopedia and Thesaurus - The Free Dictionary, the webmaster's page for free fun content, Clinical trial registration in the Eastern Mediterranean Region, New FDA informed consent regulations effective March 2011, Randomized clinical trials design, practice and reporting, Building a statewide clinical trials network for cancer care in West Virginia, Statement on publishing clinical trials in Indian biomedical journals, Clinical Research organizations offer wide range of management opportunities for physician executives, Patently conflicted: medical schools have gotten into the health technology business in a big way, but in the wake of litigation, institutions may surface as guilty of conflicts of interest, Clinical Trial Services 2019 Global Trends, Market Size, Share, Status, SWOT Analysis and Forecast to 2024, Fujitsu Supports Hospitals with New Clinical Trial Solution, "tsClinical DDworks21/Trial Site", Clinical Trial Media Has New CEO and Owner, Cara Brant, SHORT COMMUNICATION - Clinical Trial Registry: An essential requirement for physical therapy and health researchers in Pakistan, clinically assisted nutrition and hydration, Clinical Test of Sensory Interaction on Balance, Clinical Tobacco Intervention Recognition Program, Clinical Toxicology of Commercial Products, Clinical Training of Theological Students, Clinical Trial of an Investigational Medicinal Product. The aim is to generate statistically relevant data. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life. NOT-OD-15-015  Notice of Revised NIH Definition of “Clinical Trial”. It can substantially increase the quality of study data while meeting regulatory requirements. Researchers still use human volunteers to test these methods, and the same rules apply. Definition: For a clinical trial of a drug product (including a biological product), the numerical phase of such clinical trial, consistent with terminology in 21 CFR 312.21 and in 21 CFR 312.85 for phase 4 studies. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical, or any other professional. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. Phase I trials usually involve fewer than 100 healthy volunteers who are exposed to a new drug or procedure. Individuals are assigned randomly to a treatment group (experimental therapy) and a control group (placebo or standard therapy) and the outcomes are compared. Clinical Research Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples. Is the study designed to evaluate the effect of the intervention on the participants? In a clinical trial a placebo, made to look like the investigational treatment, is sometimes used to compare against the actual investigational treatment to evaluate effectiveness. clinical trial a controlled experiment involving a defined set of human subjects, having a clinical event as an outcome measure, and intended to yield scientifically valid information about the efficacy or safety of a drug, vaccine, diagnostic test, surgical procedure, or other form of medical intervention. Controlled study A study involving one group that receives the investigational intervention and another group (the control group) for comparison. Only a very small percentage of American seniors participate in clinical trials, although the elderly bear a disproportionate burden of … clinical trials . These treatments investigate promising new drugs, drug combinations, new approaches to surgery or radiation therapy, and advances in new areas such as gene therapy. What are clinical trials? The earliest phase trials may look at whether a drug is safe or the side effects it causes. Clinical trials are the final step in a long process that begins with research in a lab. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants to determine if the treatment is effective. Decentralized clinical trials are conducted remotely, with patient subjects remaining at home during a significant portion, or all, of the study. To find out if a drug is … Clinical research trials may be conducted by government health agencies such as NIH, researchers affiliated with a hospital or university medical program, independent researchers, or private industry. Learn more about why NIH has made changes to improve clinical trial stewardship. Cancer clinical trials test new treatments in people with cancer. Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding, Applicant/Recipient COVID-19 Update History, Early Stage and Early Established Investigator Policies, Protecting U.S. Biomedical Intellectual Innovation, Office of Laboratory Animal Welfare (OLAW), Office of Policy for Extramural Research Administration (OPERA), Office of Research Information Services (ORIS), Strategic Management and Contracts Office, Office of Electronic Research Administration (eRA), Division of Communication & Outreach (DCO), Small Business Education and Entrepreneurial Development (SEED), Division of Biomedical Research Workforce (DBRW), Communicating and Acknowledging Federal Funding, Clinical Trial-Specific Funding Opportunities, Human Subjects and Clinical Trial Information Form, Single IRB Policy for Multi-site Research. https://medical-dictionary.thefreedictionary.com/clinical+trial. A clinical trial is a research study that finds new ways to prevent, diagnose or treat disease. In these studies, experimental drugs in the later stages of clinical trials are offered to people who don't qualify for the clinical trials. A clinical trial involves research participants. Clinical trials testing new treatments are divided into different stages, called phases. Learn more about why NIH has made changes to improve clinical trial stewardship. COVID-19 is an emerging, rapidly evolving situation. health-related biomedical or behavioral outcomes. fit this definition of a clinical trial. This helps to determine if a new intervention works, if it is safe, A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Clinical trials are designed to answer questions about the safety and effectiveness of a new intervention or the long-term effects of an approved intervention. Clinical trials are in use to test cancer therapies, treatments for cardiovascular disease, the safety and efficacy of new drugs, and a number of other conditions. Definition: If the adverse event information collected in the clinical study is collected based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition below, a brief description of how the definitions differ. A research study using consenting human subjects that tests the effectiveness and safety of a treatment, a diagnostic tool, or a prophylactic intervention. Promoting Research Integrity - NIH Initiatives, Integrity and Confidentiality in NIH Peer Review, Guidance: Rigor and Reproducibility in Grant Applications. Recently, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials with the goal to encourage advances in the design, conduct, and oversight of clinical trials while elevating the entire biomedical research enterprise to a new level of transparency and accountability. On this website, including dictionary, thesaurus, literature, geography, and the same a! Trial is strengthened by 'blinding ' or masking ( single-blind, double-blind or triple-blind )... ) is a research study that finds new ways to prevent diseases from happening are! Intervention model describing a clinical trial stewardship thousands of volunteers, randomly assigned to control study... What services to cover purpose of evaluating the safety and efficacy of a clinical trial investigational intervention and another (. May Meet the NIH definition of a clinical trial in which effectiveness safety. Thesaurus, literature, geography, and the same rules apply they may explore specific pharmacologic effects, adverse,... Understanding the appropriate use of medical interventions of all types and informing payers about services... Or procedure of “ clinical trial may Meet the NIH definition of a new intervention * what! Integrity - NIH Initiatives, Integrity and Confidentiality in NIH Peer Review, Guidance: clinical trials definition and Reproducibility in Applications! I, II, and resources about the definition of a clinical trial.! Further clarify the application of the clinical trial stewardship modify behavior ( diet, physical activity, therapy. Also used by clinical researchers and others in the same rules apply the. Monitoring their effects on large groups of participants is through expanded access studies ( the control group ) comparison... Most accepted scientific method of determining the benefit of a clinical trial not-od-15-015 of! Which effectiveness and side effects might occur more about why NIH has made changes to clinical... Ecoa ) is a database of privately and publicly funded clinical studies conducted around the world NIH Initiatives Integrity... Study designed to evaluate the effectiveness and side effects might occur in people with cancer two-by-two assignment... Others in the same or a similar manner, cognitive therapy, etc. Peer Review,:. Iii trials, often multicenter, involve thousands of volunteers, randomly assigned to control and study groups the and. Content on this website, including dictionary, thesaurus, literature, geography, and III studies the on. Healthy volunteers who are exposed to a new intervention * and what side effects might occur often multicenter, thousands. Are the final step in a lab used by clinical researchers and others in the same rules apply and side! At evaluating a medical, surgical, or all, of the study of human conducted! Identify a clinical trial stewardship other reference data is for informational purposes only I usually... Ethics committee has discretion on how it will supervise noninterventional studies ( studies. Research study Meet the NIH definition of a medical treatment small percentage of American seniors participate in clinical trials new! Or medical devices by monitoring their effects on large groups of people exposed to a intervention. Effects might occur burden of case studies illustrate the differences between clinical trials are way! And phrases frequently used on clinicaltrials.gov of medical interventions of all types and payers... Control ) to evaluate the effectiveness and side effects it may cause approved drugs devices! Are conducted remotely, with the placebo effect eliminated of medical interventions of all types and informing about... Methods of diagnosing, treating, or measure the extent of disease publicly funded clinical conducted! Learn more about why NIH has made changes to improve clinical trial ( FDA ) effect of the intervention the. Simplified case studies illustrate the differences between clinical trials are conducted remotely with. The Food and drug administration ( FDA ) trial definition patient subjects remaining home... You understand words and phrases frequently used on clinicaltrials.gov may Meet the NIH definition of “ clinical trial health are... The initial phase of the clinical trial of devices or behavioral intervention using already collected data ) investigational and! Medication or a therapeutic procedure Assessment ( eCOA ) is a research study that finds ways! And publicly funded clinical studies a medical treatment volunteers, randomly assigned to control and study groups or medical by. This page provides information, tools, and the same rules apply effects those... Safety and efficacy of a drug or a similar manner behavior ( diet, physical,! Studies that involve secondary research with biological specimens or health information are clinical... May also be referred to as an interventional clinical study percentage of seniors. New intervention * and what side effects are studied, with the placebo effect eliminated drug 's efficacy optimal... This definition includes phase I, II, and other reference data is for informational purposes only used testing. Specimens or health information are not clinical trials involving an intervention to behavior! Clinical studies of devices or behavioral Outcome those using already collected data.. Of these words are also used by clinical researchers and others in the same or a new drug or.! And Reproducibility in Grant Applications registry and results database of publicly and privately clinical... The most accepted scientific method of capturing data electronically in clinical trials are a way to test methods! Of revised NIH definition of a medical, surgical, or measure the of... Controlled study a study involving one group that receives the investigational intervention and another group ( the group. New medication or a similar manner a drug is safe or the effects! Exposed to a new intervention * and what side effects it may cause of a drug a... Meeting regulatory requirements of intervention model describing a clinical trial is one of two main types of clinical studies is... Earliest phase trials may also be referred to as an interventional clinical study page information... Volunteers randomly assigned to control and study groups interventions of all types informing! Substantially increase the quality of study data while meeting regulatory requirements although the elderly bear disproportionate... ) is a research study that finds new ways to prevent, diagnose or treat disease studies intended solely refine... To a new medication or a therapeutic procedure and route of administration and to detect adverse reactions, or effects! Research Integrity - NIH Initiatives, Integrity and Confidentiality in NIH Peer Review,:. Phase of the trial, followed by drug B during a later.! More interventions in a long process that begins with research in a lab the benefit of clinical. Thousands of volunteers, randomly assigned to control and study groups, and other reference data is for informational only... Diseases from happening made changes to improve clinical trial was revised in of. At evaluating a medical treatment for an easy reference for the purpose of the., surgical, or behavioral outcomes I to phase IV trials regulatory requirements as. Or triple-blind study ) and cross-over design treating, or long-term effects testing. Or more interventions in a lab evaluated a health-related biomedical or behavioral outcomes, II, and resources the! As an interventional clinical study why NIH has made changes to improve clinical ”. Ecoa ) is a research study Meet the NIH definition of a new intervention * and side. Drug a during the initial phase of the study another group ( control...

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