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Research and Clinical Trials

The MWH Research Department was established in 2004 and supports our mission to improve the health of the people in the communities we serve by advancing research innovation and furthering the knowledge of healthcare professionals. We put this commitment into practice every day by conducting clinical trials. Plus, it gives our patients access to new treatments and therapies.

As a department within Mary Washington Hospital, our experienced research staff coordinates and facilitates all operational aspects of clinical trial management including regulatory compliance, IRB submissions, and approval of research proposals.

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What is clinical research?

Clinical research plays a critical role in the prevention and cure of various health disorders and involves the study of the clinical effectiveness of materials and methods. Each trial explores the possibility of prevention and cure for numerous medical disorders.

Clinical research studies examine the essential results for proper healthcare management, by monitoring practices concerning safety, effective medical practices, diagnostic techniques, devices, new medications, diagnostic tools and regiments.

See the current research and clinical trials at Mary Washington Healthcare.

What is a Clinical Trial?

A clinical trial is a research study in which volunteers, also called participants, receive investigational treatments, medications or devices under the management of a physician and research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs and devices.

Are Clinical Trials Safe?

Clinical trial study participants are monitored closely and observed for safety concerns. During the study, researchers must inform you of any new risks, benefits, or side effects they discover. In rare cases, clinical trial volunteers have been hurt by the treatment or procedure being tested.

Why do we need Clinical Trials?

Clinical trials are an important step in discovering new treatments for multiple diseases as well as detect new diseases, diagnose, and reduce the risk of disease. A clinical trial is a way we can learn to improve medical treatments and provide better care.

What questions should be asked before choosing to participate?

Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study. The following are some questions to ask the research team when thinking about a clinical trial. Make sure you bring a pen and paper to write down your questions when discussing the clinical trial.

Questions to ask about the clinical trial:

  • What is the main purpose of the study?
  • Why is this study important to me?
  • What are the chances that this drug will work?
  • What are the risks involved?
  • How much of my time will this take?
  • Does the study involve a placebo or a treatment already on the market?
  • Who do I call if I have more questions?

Questions to ask about your care:

  • What kinds of tests will be done? Will they hurt? If so, for how long?
  • Will I be able to continue to see my own doctor during the study?
  • Can I continue to take my regular medications during the study?
  • If I have side effects, can they be treated during the study?
  • Who will review information collected about me during the trial?
  • What happens if I decide to quit the study?

Questions to ask about compensation, insurance billing and costs to you:

  • Do I have to pay for any part of the study?
    • If so, will insurance cover these costs?
  • Will I be compensated for this study?

Research studies are very involved, so it is important to learn as much as possible about the study you may participate in before you consent. The U.S. Food and Drug Administration (FDA) guidelines state that study volunteers should understand the risks they're taking, which may mean spending additional time with the research staff to make sure you get the information you need. It is important to ask questions, especially if you don’t understand.

The decision to participate in a clinical trial is a personal one and one that you are entitled to make freely, without influence or coercion. Being properly informed so that you fully understand the responsibilities of becoming a study volunteer is the best way to safeguard that you are making the right decision for you.

Volunteering for a Clinical Trial

When considering volunteering for a clinical trial, it is important to make an informed decision. Here are a few frequently asked questions.

  1. What can volunteers expect if they choose to participate?
  2. What is informed consent?
  3. What are my rights as a participant?
  4. What are the benefits and risks of joining a trial?
  5. Does information remain confidential and private?
  6. What happens after the trial?

What can volunteers expect if they choose to participate?

In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers' health will continue to be monitored during and after the trial. A detailed description of what's expected of volunteers will be outlined in the study consent form along with specific clinical trial information.

What is Informed Consent?

  • It is very important to understand Informed Consent. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is the process designed to help you decide whether or not participating in a trial is right for you.

  • When you give written consent to participate in a clinical trial, you are acknowledging that you understand and accept all aspects of the research study, including any risks or benefits involved. Informed consent is a process that involves ongoing conversations between you and the research staff at all phases of the trail, including beginning, middle and end.

  • The research staff is obligated to discuss all the pertinent information about the clinical trial prior to obtaining written consent. The purpose, the procedures involved, the potential risks and benefits have to be discussed with you. If there is something you do not understand, it is your responsibility to ask questions so that you can understand.
  • You may be provided an Electronic Informed Consent (eIC) form.

More information on Electronic Informed Consent

Your rights as a participant:

If you have given consent to participate in a clinical trial, or if you have given consent on behalf of another person, you both are entitled to the following rights:

  • To be told the purpose of the clinical trial
  • To be told about all the risks, side effects, or discomforts that might be reasonably expected
  • To be told of any benefits that can be reasonably expected
  • To be told what will happen in the study and whether any procedures, drugs, or devices are different than those that are used in standard medical treatment
  • To be told about all options available to you and how they are better or worse than being in a clinical trial
  • To be allowed to ask any questions about the trial prior to consenting and/or at any time during the course of the trial
  • To be allowed ample time to decide whether or not you want to participate
  • To refuse to participate, for any reason, before and after the trial has started
  • To receive a signed and dated copy of the informed consent form
  • To be told of any medical treatments available if complications occur during the trial

It is the responsibility of the research staff to help you understand the information they provide you and to give you enough time to ask any additional questions you may have. In some instances, this may not be possible to accomplish in a single visit, therefore it is essential to take the time you need to make an informed decision. You may discover important concerns that you did not think about during the first visit.

What are the benefits and risks of joining a trial?

Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved. Volunteers may withdraw from a study at any time for any reason.

Possible benefits for volunteers:

  • Play an active role in their healthcare.
  • Gain access to research treatments before they are widely available.
  • Obtain medical care at healthcare facilities during the trial.
  • Help others by contributing to medical research.

Possible risks for volunteers:

  • There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective.
  • The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments or hospital stays.

Does information remain confidential and private?

Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access over personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.

What happens after the trial?

After a study phase is complete, the data is collected to determine the drug's effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval. If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug, in terms of its safety, effectiveness, and or assess a drug's long-term effectiveness and its impact on the quality of a person's life.


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