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Learn about Clinical Research at Hometown
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- Why Hometown Research
- What is Clinical Research
- What are Phase Trials
- Hometown Benefits
- Why You Should Participate
Hometown Research operates out of several of our state-of-the-art urgent care centers. We are a highly experienced clinical research company where patient safety is our primary concern. We have conducted research for over five years and our reputation for excellence is built upon the contributions of our many patient volunteers.
We offer professional, medical settings within our urgent care centers with private exam rooms and a dedicated research staff with a passion for research. Our research doctors take time to personally meet with the research patients throughout the study. We have successfully completed over 100 trials for a variety of different diseases and conditions. Our patient volunteers choose Hometown Research because our attentive doctors provide consistent, comprehensive medical care.
A clinical trial is a set of procedures conducted in medical research and drug development to make sure a new drug or device is safe and effective for a particular condition. These procedures are the steps followed before the FDA will approve the new drug or device. Each clinical trial process depends on the type of trial being conducted. The physician conducting the clinical trial will be able to give you more detail on how many visits will be required, what you’ll need to do at home, etc. during the initial consultation.
Phase II Studies
- Before a new treatment is tested in a clinical trial, it undergoes extensive laboratory testing, often for many years. Only the most promising new treatments make it to clinical trials.
- Patients decide to participate in clinical trials for many reasons, usually because they hope for a cure, a longer life span or an improved quality of life.
- Clinical trials are governed by protocols, or plans that spell out exactly what will happen and why. Protocols are carefully reviewed to make sure they safeguard patients and have scientific merit.
- If it becomes clear during a clinical trial that one treatment is better than another, the trial is stopped so that all patients receive the treatment. The patients in the trial are the first to benefit.
- Placebos are sometimes used in clinical trials. Patient safety is the first goal. All trials are conducted under strict supervision of the specialist doctor.
- In a clinical trial, you receive close monitoring of your health care and any side effects.
- You can leave a clinical trial at any time, and choose instead to receive the best available standard care.
- All clinical trial are conducted under the authority of Institutional Review Boards, which are independent authorities that oversee that the safety rights and welfare of patients are never compromised.
Phase III Studies
In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug’s effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request for FDA approval for marketing the drug.
Phase IV Studies
In late III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.
At Hometown Research our first and foremost priority is your safety and comfort. To ensure your safety our experienced physicians and clinical staff strictly follow the guidelines of FDA and the comprehensive guidelines given for each study. Our friendly staff is available for any questions and concerns. Besides the drug companies have 24 hours hotline to answer emergency questions.
Dedicated Clinical Team
Our staff consists of experienced physicians, fully staffed clinical research team, on site emergency response personnel, strict adherence to Code of Federal Regulations (CFR), GCP and HIPAA. Stellar customer service is always the norm.
At Hometown Research Center you will find:
- Board Certified, Experienced Investigators
- IATA DOT Certified Specialist
- GCP trained personnel
- Positive community support
- Multi-ethnic patient population
- ACLS Certified Staff
- Major Hospital within 5 mi.
- 24/7 contact number
- Competent clinical research coordinators
Hometown Research maintains an environment of trust, open communication, and a “managing with respect” philosophy.
Participation in clinical trials allows access to medications and medical treatments that are not yet available to the general public. If you are going through treatment for a condition and are not satisfied with the results, a clinical trial might be a good option for you. Generally, the medication and examinations are provided at no cost and you may be reimbursed for your time and travel expenses.
- Gain access to advanced medical care, new medications, and treatments not yet available to the general public
- Play an active role in your own health care
- Help others by contributing to medical research
- Get reimbursed for your time and expenses (available for some clinical trials)
What are clinical trials?
A clinical trial is a research study to answer specific questions about new therapies, vaccines or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Why participate in clinical trials?
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.
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 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. 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 that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a recording device to record the discussion to replay later.
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 new treatment being tested may be effective?
- Has it been tested before?
- What kinds of tests and 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?
- Who will pay for the 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 treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
Does a participant continue to work with a primary health care provider while in a trial?
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to:
- Play an active role in their 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.
- There are risks to participating in a clinical trial.
- There may be unpleasant, serious or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, or complex dosage requirements.
How is the safety of the participant protected?
Can a participant leave a clinical trial after it has begun?
Where do the ideas for trials come from?
Who sponsors clinical trials?
What is informed consent?
What is a protocol?
What is a placebo?
What is a control or control group?
What are Clinical Trial Phases?
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.
Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.