> Research
ProHealth is committed to improving clinical care processes and outcomes through the activities of our research network. With eight years of research experience, ProHealth has a reputation for quality results.
Research efforts measure the efficiency and effectiveness of care processes and patient satisfaction. We conduct clinical research trials and outcomes projects to test effectiveness of new treatments, measure safety and cost, and to improve the overall health of our patients.
The network and various sponsors work together to develop and implement new health initiatives. The research department manages all administrative duties, including regulatory and IRB (Institutional Review Board) submissions, budget negotiations and contract approvals. In addition, we provide sponsors and clinical research organizations with experienced principal investigators and a well- developed research management team.
The network has access to medical charts, electronic diagnostic databases and a clinical lab database of more than 350,000 patients. When needed, targeted communications and advertising programs are used to guarantee efficient and effective patient recruitment.
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Clinical Research Trial Management
What is a clinical trial?
Before a drug can be sold in the United States it must be tested and evaluated for safety and effectiveness. A clinical trial is a research study to answer specific questions about new medications. Clinical trials begin at Phase I and proceed to Phase IV. Phase I studies are done on healthy volunteers to measure how the drug is processed by the body. Once the product has passed this phase it is then tested on patients with the disease or condition for which the product will be used, such as hypertension or asthma.
The number of patients included in a clinical trial increases as the drug passes through Phase II and III. Once the Food and Drug Administration (FDA) approves the drug, Phase IV studies are conducted to ensure the product is safe to use. The research network participates in Phase II - Phase IV studies.
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Who participates in clinical trials?
There are four major participants in clinical trials, the sponsor, the FDA, the investigator (physician), and the patient. Each has an important role to play.
The sponsor—in most instances a pharmaceutical company—is the organization that funds the research. It is this company that owns the drug that is being tested. Over 90% of all medications available today are the result of pharmaceutical company research. The sponsor must write a protocol (a specific set of instructions) to let the FDA and the investigator know exactly how the study will be conducted.
On occasion, pharmaceutical companies will hire a Contract Research Organization (CRO) to assist in the running of the study. The FDA oversees all clinical trials in the United States. It is the FDA that makes sure all laws pertaining to clinical research are followed by the sponsor and the investigator. In addition to the FDA, the IRB is used for each study to review the protocol and all materials given to the patient. The combination of the FDA and the IRB helps protect patients' rights.
The investigator conducts the clinical trial. These trials can be performed at the physician's office or at another healthcare setting such as a hospital or nursing home. It is the investigator's responsibility to follow the rules of the protocol and to monitor the safety and health of the patient. Nurses and other staff members help investigators carry out the procedures of the clinical trial.
The patient has a very important job in the clinical research study. Studies can only be conducted if patients volunteer. To protect the patient, an informed consent must be signed before any study procedure can be performed or study drug given. The informed consent will contain all the information a patient needs to know before agreeing to participate in a study. The patient will be told why the research is being done, what the researchers what to accomplish, what will be done during the trial and for how long, what risks are involved in the trial, what benefits can be expected from the trial and what other treatment options are available.
Once a patient agrees to participate in a trial, the patient must follow all directions from the investigator and the study staff. Patients may be asked to take the study medication every day, complete diaries of side effects, or answer questions by phone. For each study patient requirements will be different, but they will always be explained in the informed consent. At any time during the study, the patient may choose to leave the study. Patients may receive payment for their time and travel required to participate in a clinical trial.
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The network’s responsibilities
The research network provides the front-end clinical trial administration. We are the single point of contact for the following services:
- initial regulatory submission
- central IRB approval process
- contract and budget negotiations
- patient recruitment
- trial tracking
- record retention
All ProHealth sites that participate in clinical research must be credentialed by the research network before accepting a research protocol on behalf of the network. The credentialing process ensures that each site has the proper equipment to conduct clinical trials, has adequate space for patients, documents and monitors, and has identified a dedicated study coordinator.
The network will also observe each site from a quality assurance perspective, making certain protocols are being followed, the informed consent process is conducted properly and patient confidentiality is maintained.
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Outcomes Project Management
What is outcomes research?
Outcomes research projects often examine quality of life issues surrounding certain diseases or conditions that affect a large number of patients, for example, atopic dermatitis or chronic constipation. The projects are generally designed to evaluate how patients feel about their condition, how patients react to their physicians’ treatment, how the disease affects patients’ quality of life and what treatment methods physicians’ use for those diseases and conditions.
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Who participates in outcomes research?
Similar to clinical research trials, outcomes research projects are monitored by one or two principal investigators, conducted by multiple physicians managed by the research team and often sponsored by a pharmaceutical company or Contract Research Organization (CRO). The Institutional Review Board (IRB) reviews the protocol and any material given to the patient and/or provider. Though outcomes research projects do not involve testing of specific medications, the IRB must review all project related materials. The IRB ensures that all project procedures are not endangering the patient and all of their rights are protected.
The sponsor of the outcomes research projects is the organization that funds the research. In most instances a pharmaceutical company is the sponsor; however, in other instances it can be a Contract Research Organization or a government agency. In outcomes research either the research team or the sponsor will write a protocol, a specific set of instructions about a particular disease or condition, indicating exactly how the study will be conducted.
The investigators conduct the outcomes research projects. These projects can be performed at the physician's office or are as simple as having the patient complete a survey. It is the investigator's responsibility to follow the rules of the protocol and to monitor the safety and health of the patient. Nurses, the research team and other staff members help the investigators carry out the procedures of the outcomes project.
The patient is the most valuable source of information in an outcomes research project. These projects can only be conducted if the patient volunteers. To protect the patient, an informed consent must be signed before any study procedure can be performed. The informed consent will contain all the information a patient needs to know before agreeing to participate in a project. The patient will be told why the research is being done, what the researchers what to accomplish, what will occur during the project and for how long, what risks are involved, and what benefits can be expected from the project.
Once a patient agrees to participate in a project, the patient must follow all directions from the investigator and the study staff. Patients may be asked to complete surveys, fill out diaries of events or answer questions by phone. For each project, the patient requirements will be different, but they will always be explained in the informed consent. At any time during the project, the patient may choose to leave. Patients may receive payment for their time required to participate in an outcomes research project.
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The network’s responsibilities
Similar to clinical trials, the research network provides all of the administration. We are the single point of contact for the following services:
- regulatory submission
- central IRB approval process
- contract and budget negotiations
- patient recruitment
- patient payment
- reporting
- record retention
- occasionally data analysis
The network will also observe each site from a quality assurance perspective, making certain protocols are being followed, the informed consent process is conducted properly, and patient confidentiality is maintained.
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Other Resources for Information About Clinical Trials
www.clinicaltrials.gov sponsored by the National Institute of Health
www.fda.gov sponsored by the FDA
www.centerwatch.com sponsored by Centerwatch, an independent research organization
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Contact Information
Director of Research
John Lynch
(860)284-5288
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