Apothecaries Clinical Research




What is a clinical trial?
What is a Protocol?
Why participate in a clinical trial?
What questions should I ask before I agree to be in a clinical trial?
Where are clinical trials conducted?
Who can participate in a clinical trial?
What happens during a clinical trial?
What is informed consent?
What are side effects and adverse reactions?
How is the safety of the participant protected?
What is a placebo?
What are the main types and phases of clinical trials?
Will I be paid for participating in a clinical trial?


What is a clinical trial?		Top
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. There are different kinds of clinical trials, including those to study:

prevention options new treatments or new ways to use existing treatments new screening and diagnostic techniques options for improving the quality of life for people who have serious medical conditions
Usually, clincal trials compare a new product or therapy to something else to see if it works as well or better to treat or prevent a disease or condition.

What is a Protocol?		Top
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

Why participate in a clinical trial?		Top
Participanting in clinical trials can play a more active role in your own healthcare. You may gain access to new research treatments before they are widely available and expert medical advice during the course of the trial. You also help others by contributing to medical research.


What questions should I ask before I agree to be in a clinical trial?		Top
You have the right to ask any number of questions prior to volunteering. They may include:

Has this drug been tested on humans before? If so, to what extent? What is the purpose of the drug? What are the expected risks? Which company developed the drug? Will there be any complicated procedures carried out? What is the samples type and how often will they be taken? How long does the trial last?

Where are clinical trials conducted?		Top
Clinical trials can be sponsored by an organization such as a pharmaceutical company, a governmental agency. The sponsor determines the location(s) of the trials which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.

Who can participate in a clinical trial?		Top
All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. Healthy volunteers who seek to advance knowledge about causes, progress, and treatment of disease also can participate in clinical research. They provide important medical information to researchers by helping them compare how healthy people differ medically from those who have a specific disease.

What happens during a clinical trial?		Top
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

What is informed consent?		Top
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study in the participant’s native language at a level of complexity which the participant can understand. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

What are side effects and adverse reactions?		Top
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects. What should people think about before joining a clinical trial? People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive, and any costs to them - which may or may not include the cost of the product, costs associated with administering the product, etc.

How is the safety of the participant protected?		Top
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is regulated with built in laws to protect the participants. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.

What is a placebo?		Top
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in a group will receive a placebo instead of an active drug or experimental treatment.

What are the main types and phases of clinical trials?		Top
There are four types of drug studies: Phase 1 studies test a potential new drug with a small number of volunteers for best dosage and potential side effects. Phase 2 studies test a drug with known dose and side effects with a larger number of volunteers to learn more about side effects, how the body uses the drug, and how the drug helps the condition. Phase 3 and 4 studies compare the new drug with a commonly used drug, treatment or placebo.

Will I be paid for participating in a clinical trial?		Top
Subjects are sometimes paid for their participation in research, especially in the early phases. Payment to research subjects for participation in studies is considered as a recruitment incentive. Financial incentives are most often used when health benefits to subjects are little or nonexistent. Volunteers may be offered compensation in certain trials for their time, for travel expenses to the trial location and for discomfort that may be experienced during the trial.