An Important Decision

Choosing to participate in a clinical trial is an important personal decision. It is often helpful to talk to your physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.

What is Clinical Research?

Clinical research involves the introduction of a new investigational product into humans and the subsequent studies conducted to evaluate the safety and efficacy of that product. All Food and Drug Administration (FDA) approved medicines from pain killers to antibiotics have to undergo extensive research and testing before they reach the public health systems. It is at the final stages of this research that volunteers are needed from the community to participate in these trials.

 

Why should I volunteer?

Clinical research offers an opportunity to participate in the study of new pharmaceutical drugs that are in the development pipeline. In exchange for your participation in a clinical trial, you will receive medical care for the condition under study, medication, and comprehensive evaluation, all at no charge. In most cases you will be compensated for your time and effort.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. In any event, you will have the satisfaction of participating in something that may not only benefit yourself, but society as well. Optimum Clinical Research, Inc. makes the process of participation easy and efficient.

 

Why is my physician participating in clinical research?

Clinical trial investigators (physicians) play an integral role in the development of new medicines and medical devices used to help combat disease, treat chronic and degenerative diseases, and improve the health of people worldwide. There is a continual need for physicians in private practice to join in the pursuit of advancing medicine as clinical trial investigators. 

 

The top reasons include:

  • Professional development: Be on the cutting edge of your therapeutic area of expertise, meet other investigators, exchange ideas, plan future collaborations, and work with investigational medications and processes that are not yet approved by the FDA.

  • Professional recognition: Use your role as an investigator to co-author articles for publication and be recognized as a thought leader within the medical community.

  • Personal satisfaction: Offer your patients new medical treatments that may only be available through participation in clinical trials

  • Role in the advancement of medicine: Be a leader in your field by potentially bringing breakthrough drugs and medical devices - products that could impact the health of people around the world - to market.

 

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called 'inclusion criteria' and those that disallow someone 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. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. 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. The criteria help ensure researchers will be able to answer the questions they plan to study.

 

What are the different Study Phases?

 

  • Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing is generally first in man, and is done in a small number of healthy volunteers (20 to 100). The study is designed to determine what happens to the drug in the human body, how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased.

 

  • Phase II/III: This phase of testing may last from several months to two years, and involve up to several hundred patients. This phase is done to test drug effectiveness.

 

  • Phase IV: This final phase of testing is done to compare a drug with other drugs already on the market. Studies are often designed to monitor a drug’s long-term effectiveness and optimal use. Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

 

 

What are the risks and benefits of participating in clinical research?
Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in your own health care.

  • Gain access to new research treatments before they are widely available.

  • Obtain expert medical care at leading health care facilities during the trial.

  • Help others by contributing to medical research.

 

Risks
  • The experimental treatment may not be effective for the participant.

  • The study design may require more of their time and attention than other forms of treatment, including trips to the study site, more treatments, or complex dosage requirements.

  • There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.

 
How will participant safety be protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. 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. Participants may discontinue the trial at any time and study doctors reserve the right to discontinue participants if they feel safety is compromised at any time.

 
What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

  • What is the purpose of the study?

  • Who is going to be in the study?

  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?

  • What kinds of tests and experimental treatments are involved?

  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?

  • How might this trial affect my daily life?

  • How long will the trial last?

  • Will hospitalization be required?

  • Who will pay for the experimental treatment?

  • Will I be reimbursed for other expenses?

  • What type of long-term follow up care is part of this study?

  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?

  • Who will be in charge of my care?

 
What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. 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.

Still have questions: contact us: info@exemplarresearchinc.com 

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