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Clinical Trial Research with a Global Impact

Clinical Trials as a Care Option

At Physicians Research Group, our mission is to improve people's lives through the advancement of safe and effective medical treatments. Our sole focus is Clinical Research, which ensures all of our clinical trial partners — Participants, Sponsors, and Investigators — can count on us for unparalleled service, safety and exceptional performance across our network.

Patient/Participants ♦ Sponsors ♦ Investigators

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100% Patient-Driven

We consider our Patient/Participant needs and interests first and foremost! Although we answer to our Sponsors and Investigators as well, we are 100% Patient Driven. 

You can expect exceptional medical care and unmatched attention to detail from our team of expert physicians and researchers. At Physicians Research Group, we all share a common goal to keep our patients' fully informed and completely updated every step of the way. We conduct research based on patient care, not based on enrollment numbers or outside demands.

 

 

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(Clinical Trials, Available Studies and Patient Benefits)

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Dedicated to Sponsor Results

At Physicians Research Group we can only be Dedicated to Sponsor Results by remaining 100% Patient-Driven. We have found through our years of successful Clinical Trials and high Industry Success Rates, that when the patient is truly taken care of the numbers take care of themselves.

Our Better Data is a direct result of an extremely efficient Research Process coupled with exceptional Staff Training. The result is Patient Satisfaction and Higher Compliance Rates which, in turn, leads right back to Better Data for our Sponsors.

 

 

Learn More about Sponsors

(Higher Compliance and Success Rates for Sponsors)

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Committed to Investigator Success

Our Investigational Partners are an equally important part of the equation, and we treat them as such. PRG can attract top Physician Investigators for the same reason that we can achieve Better Data and extremely high Patient Satisfaction Rates.

An efficient Research Process that is custom tailored to each independent practice and study management services where we handle all the paperwork are just two of the many benefits enjoyed by our Investigators.

 

 

Learn More about Investigators

(Clinical Trials as a Care Option and Investigator Benefits)

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Our Success is a result of YOUR SUCCESS!

Bringing together the three critical components of Clinical Research - Patient, Sponsor and Investigator, and providing an exceptional Research Process and unmatched Customer Service is what we do!

At Physicians Research Group we see everyone as part of the same team. All working together for a common goal. Leading Medical Research that will Change the World!

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Physicians Research Group LEADS Medical Innovation in Arizona and across the Globe!

Learn how you can make a difference.

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Frequently Asked Questions

[fa icon="plus-square-o"] What is a Clinical Trial?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies. PRG participates in both clinical trial and observational studies.
[fa icon="plus-square-o"] Who can participate in a clinical trial?
Clinical studies have standards outlining who can participate, called eligibility criteria, which are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied. Other studies are looking for healthy participants. And some studies are limited to a predetermined group of people who are asked by researchers to enroll.

Eligibility 

The factors that allow someone to participate in a clinical study are called inclusion criteria, and the factors that disqualify someone from participating are called exclusion criteria. 
[fa icon="plus-square-o"] What are the phases of a clinical Trial?
In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators and/or sponsors (pharmaceutical industry). These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet. Clinical trials may compare a new medical approach to a standard one that is already available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators and/or sponsors try to determine the safety and efficacy or effectiveness (whether the drug works in people who have a certain disease or condition) of the intervention by measuring certain outcomes in the participants. 

Clinical trials used in drug development are typically labeled by phase; there are five (5) different phases:

Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals. 

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted. 

Phase 2: Studies that gather preliminary data on effectiveness. For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. 

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. 

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including post-market requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.
[fa icon="plus-square-o"] How am I protected?
Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. 

Institutional review boards (IRBs)

Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.

Various Federal agencies, including the Office of Human Subjects Research Protection (OHRP) and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.

Relationship to Usual Health Care

Typically participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having the participant's usual health care provider work with the research team, the participant can make sure that the study protocol will not conflict with other medications or treatments being received.
[fa icon="plus-square-o"] Who conducts clinical trials?
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other healthcare professionals.

Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs. Physicians, health care providers, and other individuals can also sponsor clinical research.

A clinical study is conducted according to a research plan known as the protocol. The protocol is designed to answer specific research questions as well as safeguard the health of participants. It contains the following information:

1. The reason for conducting the study

2. Who may participate in the study (the eligibility criteria)

3. The number of participants needed

4. The schedule of tests, procedures, or drugs and their dosages

5. The length of the study

6. What information will be gathered about the participants
[fa icon="plus-square-o"] What considerations and questions should I ask?
Considerations for Participation

Participating in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.

Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some trials may provide participants with the prospect of receiving direct medical benefits, while others do not. Most trials involve some risk of harm or injury to the participant, although it may not be more than the risks related to routine medical care or disease progression. (For trials approved by IRBs, the IRB has decided that the risks of participation have been minimized and are reasonable in relation to anticipated benefits.) Many trials require participants to undergo additional procedures, tests, and assessments based on the study protocol. These will be described in the informed consent document for a particular trial. A potential participant should also discuss these issues with members of the research team and with his or her usual health care provider.

Questions to Ask

Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent form (ICF). Many of these questions are specific to clinical trials, but some also apply to observational studies.

·       What is being studied?

·       Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?

·       What are the possible interventions that I might receive during the trial?

·       How will it be determined which interventions I receive (for example, by chance)?

·       Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?

·       How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?

·       What will I have to do?

·       What tests and procedures are involved?

·       How often will I have to visit the hospital or clinic?

·       Will hospitalization be required?

·       How long will the study last?

·       Who will pay for my participation?

·       Will I be reimbursed for other expenses?

·       What type of long-term follow-up care is part of this trial?

·       If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?

·       Will results of the study be provided to me?

·       Who will oversee my medical care while I am in the trial?

·       What are my options if I am injured during the study?