What is a Clinical Trial or Clinical Study?
A Clinical Trial or Clinical Study is an investigation of a drug (called Investigational Product) or a device and the effects it has in the human body. The trial assesses how the drug reacts in the body, what adverse effects may occur, and how the medication is absorbed and/or excreted in the body. Clinical studies help the medical community determine better treatments for diseases, improved ways of diagnosing disease and how to prevent disease. Our studies are regulated according to FDA regulations and are monitored on an ongoing basis for accuracy.
A Clinical Trial or Clinical Study is an investigation of a drug (called Investigational Product) or a device and the effects it has in the human body. The trial assesses how the drug reacts in the body, what adverse effects may occur, and how the medication is absorbed and/or excreted in the body. Clinical studies help the medical community determine better treatments for diseases, improved ways of diagnosing disease and how to prevent disease. Our studies are regulated according to FDA regulations and are monitored on an ongoing basis for accuracy.
There are four main phases of a research study or trial
Phase 1 Study
In a Phase 1 study, humans are given a new drug for the first time. Usually, healthy people are enrolled in Phase 1 studies. Sometimes people with certain diseases may also be enrolled. Phase 1 studies help find out how a drug is broken down in the human body and how it interacts with the human body. Phase 1 studies reveal some of the side effects associated with a new drug. Information from Phase 1 studies is used to develop Phase 2 studies. Phase 1 studies can involve two groups, one group of people who get the new drug and another group which gets an inactive medication called a placebo. Phase 1 studies typically consist of 20-80 people and have a short duration of days or a few weeks. Pharmacokinetics (drug’s absorption, distribution, metabolism and excretion) and pharmacodynamics (drug blood levels of PK/PD studies) are assessed during Phase 1 trials.
Phase 2 Study
In a Phase 2 study, a new drug is tested to see if it helps improve a particular illness. Researchers give the drug to people with the disease under study at the doses, and on the schedule, found to be safe in Phase 1 trials. During Phase 2, researchers collect additional data on the safety and efficacy of a drug, including short-term side effects and risks, and collect additional information about the proper dose and dosing schedule. Phase 2 studies often have at least two groups, people who get the new drug and people who get placebo; sometimes a standard treatment is also included for comparison. About 100 to 250 people are included in a typical Phase 2 study, which lasts on the order of weeks.
Phase 3 Study
In a Phase 3 study, research is expanded to longer, larger trials, after Phase 1 and Phase 2 studies have shown that the risk of side effects from a new drug is generally outweighed by its being helpful for the illness under study. However, since Phase 1 and Phase 2 studies include only a few hundred patients total, Phase 3 studies gather additional information needed to evaluate the overall benefit-risk relationship of a drug. Researchers collect additional information about drug-related side effects, including less common side effects. Several hundred to several thousand participants may be enrolled. Phase 3 studies commonly have at least two groups, people who get the new drug and people who get placebo, as well as a standard treatment group included for comparison. At the conclusion of a properly designed Phase 3 trial, the new drug will be found to be inferior, equivalent, or superior to placebo and/or the standard treatment. About 300 to 3,000 people are included in a typical Phase 3 study, which lasts on the order of weeks to months.
Phase 4 Study
The intent of Phase 4, or post-marketing studies, is to learn more about the drug after it has been approved by government authorities. In Phase 4 studies, researchers gather information about an approved drug's risks, benefits, and best uses in ‘real-life’ conditions. These studies can also include trials of different doses or schedules of administration, other stages of disease or other disease and age groups, cost studies, quality-of-life studies, or use of the drug over a longer period of time.
In a Phase 1 study, humans are given a new drug for the first time. Usually, healthy people are enrolled in Phase 1 studies. Sometimes people with certain diseases may also be enrolled. Phase 1 studies help find out how a drug is broken down in the human body and how it interacts with the human body. Phase 1 studies reveal some of the side effects associated with a new drug. Information from Phase 1 studies is used to develop Phase 2 studies. Phase 1 studies can involve two groups, one group of people who get the new drug and another group which gets an inactive medication called a placebo. Phase 1 studies typically consist of 20-80 people and have a short duration of days or a few weeks. Pharmacokinetics (drug’s absorption, distribution, metabolism and excretion) and pharmacodynamics (drug blood levels of PK/PD studies) are assessed during Phase 1 trials.
Phase 2 Study
In a Phase 2 study, a new drug is tested to see if it helps improve a particular illness. Researchers give the drug to people with the disease under study at the doses, and on the schedule, found to be safe in Phase 1 trials. During Phase 2, researchers collect additional data on the safety and efficacy of a drug, including short-term side effects and risks, and collect additional information about the proper dose and dosing schedule. Phase 2 studies often have at least two groups, people who get the new drug and people who get placebo; sometimes a standard treatment is also included for comparison. About 100 to 250 people are included in a typical Phase 2 study, which lasts on the order of weeks.
Phase 3 Study
In a Phase 3 study, research is expanded to longer, larger trials, after Phase 1 and Phase 2 studies have shown that the risk of side effects from a new drug is generally outweighed by its being helpful for the illness under study. However, since Phase 1 and Phase 2 studies include only a few hundred patients total, Phase 3 studies gather additional information needed to evaluate the overall benefit-risk relationship of a drug. Researchers collect additional information about drug-related side effects, including less common side effects. Several hundred to several thousand participants may be enrolled. Phase 3 studies commonly have at least two groups, people who get the new drug and people who get placebo, as well as a standard treatment group included for comparison. At the conclusion of a properly designed Phase 3 trial, the new drug will be found to be inferior, equivalent, or superior to placebo and/or the standard treatment. About 300 to 3,000 people are included in a typical Phase 3 study, which lasts on the order of weeks to months.
Phase 4 Study
The intent of Phase 4, or post-marketing studies, is to learn more about the drug after it has been approved by government authorities. In Phase 4 studies, researchers gather information about an approved drug's risks, benefits, and best uses in ‘real-life’ conditions. These studies can also include trials of different doses or schedules of administration, other stages of disease or other disease and age groups, cost studies, quality-of-life studies, or use of the drug over a longer period of time.
What are some examples of clinical trials?
Penicillin
Alexander Fleming discovered penicillin in the 1930s changed the medical world changed because bacterial infections were able to be treated. Prior to the discovery of penicillin, many people died of simple infections such as a sore throat. It was the beginning of a range of antibiotics that are now used to treat multiple bacterial infections.
Anesthetics
Many people prior to the discovery of anesthesia opted death over the pain of surgery. Anesthesia was a major discovery allowing doctors to treat major medical issues through surgery.
Oral contraceptives
Contraceptives are a major drug that is used to prevent a condition. Four out of five women have used oral contraceptives at one point in their lives.
Insulin
Diabetes was once a gravely feared disease often resulting in major body issues and early death. Now through insulin many diabetics live long, normal lives.
Penicillin
Alexander Fleming discovered penicillin in the 1930s changed the medical world changed because bacterial infections were able to be treated. Prior to the discovery of penicillin, many people died of simple infections such as a sore throat. It was the beginning of a range of antibiotics that are now used to treat multiple bacterial infections.
Anesthetics
Many people prior to the discovery of anesthesia opted death over the pain of surgery. Anesthesia was a major discovery allowing doctors to treat major medical issues through surgery.
Oral contraceptives
Contraceptives are a major drug that is used to prevent a condition. Four out of five women have used oral contraceptives at one point in their lives.
Insulin
Diabetes was once a gravely feared disease often resulting in major body issues and early death. Now through insulin many diabetics live long, normal lives.
How are clinical trials developed?
A clinical trial is created and the full trial design is outlined in a protocol. The protocol must be approved by a regulatory body called an Institutional Review Board or IRB. The protocol must be specific in what is being studied, who is allowed in the study, how many visits there will be in a study, what will happen at each visit, the type of drug or device that is being studies and why it is being studied. Prior to a study with human subjects a drug or device is tested in the laboratory for basic safety. Please read the different phases of a study listed above that outlines the study development.
A clinical trial is created and the full trial design is outlined in a protocol. The protocol must be approved by a regulatory body called an Institutional Review Board or IRB. The protocol must be specific in what is being studied, who is allowed in the study, how many visits there will be in a study, what will happen at each visit, the type of drug or device that is being studies and why it is being studied. Prior to a study with human subjects a drug or device is tested in the laboratory for basic safety. Please read the different phases of a study listed above that outlines the study development.
What is informed consent?
The Informed Consent is a document that outlines all information on the study. Every person considering enrollment in a study must read and understand the Informed Consent. The medical doctor and nurse coordinator will answer any questions that you have on the study. Items that are listed in the Informed Consent include:
● The basic study design including what happens at each visit and all tests and treatments to be done
● The purpose of the study and why researchers believe the treatment may be beneficial
● The possible benefits and risks of the study and how they compare to the current approved treatments available
● The length of the trial
● Compensation you will receive for your time
● Who will be in charge of your care and how to contact them
What are some benefits of participating in Clinical Research?
You may help others by contributing to medical research. You will have access to novel experimental drugs and devices. Your care related to research will be provided at no cost and you will be playing an active role in your health care.
What are some possible risks of participating in Clinical Research?
The treatment may not be effective. You may be inconvenienced by the time and procedures required for participation and there may be unpleasant side effects.
How safe is it to participate in Clinical Research?
Clinical trials have strict regulations from the FDA. A protocol (study design) is approved by the FDA before it becomes a Clinical Trial. There are multiple phases of trials for the drug development that are strictly adhered to. An IRB is a committee of physicians, community advocates and scientific members and other professional people who ensure that a trial is ethical and that participant’s rights are protected. They also monitor the safety of the trial throughout the trial. All of our trials are led and managed by a physician.
All trials are done according to Good Clinical Practice (GCP) which is the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting in clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.
During the trial a monitor verifies the trial data for accuracy and assures that the procedures are being done according to the protocol.
What is an investigational product?
The Investigational Product is the drug being studied. The plan for distributing the study drug is outlined in the protocol. The Informed Consent also contains information on the Investigational Product. Studies will have a randomization plan which outlines how the drug is given. There are different arms or groups with different doses or types of drugs in many protocols. Some studies have a placebo arm which means it will be an inactive medication. Placebos are compared to the Investigational Product to assess the effectiveness of the Investigational Product. Some studies have an arm that receives a drug that is already available and compares its effectiveness with the Investigational Product. Many trials have arms with different dose ranges that are compared for effectiveness.
How is a participants' privacy protected?
We abide by HIPAA laws and all of your information is kept confidential. Your information is known as a number and not a name. We do use your initials. No name identifying information is given for your trial data.
The Informed Consent is a document that outlines all information on the study. Every person considering enrollment in a study must read and understand the Informed Consent. The medical doctor and nurse coordinator will answer any questions that you have on the study. Items that are listed in the Informed Consent include:
● The basic study design including what happens at each visit and all tests and treatments to be done
● The purpose of the study and why researchers believe the treatment may be beneficial
● The possible benefits and risks of the study and how they compare to the current approved treatments available
● The length of the trial
● Compensation you will receive for your time
● Who will be in charge of your care and how to contact them
What are some benefits of participating in Clinical Research?
You may help others by contributing to medical research. You will have access to novel experimental drugs and devices. Your care related to research will be provided at no cost and you will be playing an active role in your health care.
What are some possible risks of participating in Clinical Research?
The treatment may not be effective. You may be inconvenienced by the time and procedures required for participation and there may be unpleasant side effects.
How safe is it to participate in Clinical Research?
Clinical trials have strict regulations from the FDA. A protocol (study design) is approved by the FDA before it becomes a Clinical Trial. There are multiple phases of trials for the drug development that are strictly adhered to. An IRB is a committee of physicians, community advocates and scientific members and other professional people who ensure that a trial is ethical and that participant’s rights are protected. They also monitor the safety of the trial throughout the trial. All of our trials are led and managed by a physician.
All trials are done according to Good Clinical Practice (GCP) which is the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting in clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.
During the trial a monitor verifies the trial data for accuracy and assures that the procedures are being done according to the protocol.
What is an investigational product?
The Investigational Product is the drug being studied. The plan for distributing the study drug is outlined in the protocol. The Informed Consent also contains information on the Investigational Product. Studies will have a randomization plan which outlines how the drug is given. There are different arms or groups with different doses or types of drugs in many protocols. Some studies have a placebo arm which means it will be an inactive medication. Placebos are compared to the Investigational Product to assess the effectiveness of the Investigational Product. Some studies have an arm that receives a drug that is already available and compares its effectiveness with the Investigational Product. Many trials have arms with different dose ranges that are compared for effectiveness.
How is a participants' privacy protected?
We abide by HIPAA laws and all of your information is kept confidential. Your information is known as a number and not a name. We do use your initials. No name identifying information is given for your trial data.
IF YOU HAVE ADDITIONAL QUESTIONS PLEASE CALL US AT (636) 220-1200 OR EMAIL US AT info@clinicalresearchprofessionals.net
