CLINICAL TRIALS

 

OUR RESEARCH TEAM

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Michael Goldsby, Ph.D., CCRP

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Kalea Buzbee, RN, BSN
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Sue Goldsby, RN, PMH-BC
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Randi Lane, BS

Family Psychiatry of the Woodlands is dedicated to offering our patients and the community the best mental health care possible. One of the many ways we achieve optimal care is through the opportunity of clinical trials. Clinical trials can open doors for participants to experience the most advanced technology in pharmaceuticals. Participants can benefit from the most promising drugs, while receiving the most attentive and continuous standards of care. We deeply value the contribution that our clinical trial participants make to the development of safe and effective medications. All our participants receive thorough psychiatric and medical evaluations prior to enrollment in a study and are closely monitored according to the IHC Principles of Good Clinical Practice standards for the duration of the trial. Participants receive all care throughout the trial free of cost.

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CURRENT & UPCOMING TRIALS

Our team conducts phases I through IV psychiatric clinical trials including but not limited to Major Depressive Disorders, Bipolar Disorders, ADHD, Autism, and Schizophrenia.

 

  • Child & Teen ADHD (ages 6-17)
    Email Sue at sgoldsby@woodlandspsych.com or call 832-616-2675 or Kalea at kaleab@woodlandspsych.com
     

  • Child ADHD (ages 4-12)
    Email Sue at sgoldsby@woodlandspsych.com or call 832-616-2675
     

  • Child & Teen Bipolar (ages 10-17)
    Email Randi at rlane@woodlandspsych.com or call 832-616-2677
     

  • Teen Schizophrenia ( ages 13-17)
    Email Randi at rlane@woodlandspsych.com or call 832-616-2677
     

  • Teen Depression ( ages 13 to 17)
    Email Kalea at kaleab@woodlandspsych.com or call 832-616-2673
     

  • Adult Treatment Resistant Depression ( ages 18 & up)
    Email Kalea at kaleab@woodlandspsych.com or call 832-616-2673

 

Clinical trials faq

What is Clinical Research?


Clinical research refers to studies in which people participate as patients or volunteers. Different terms are used to describe clinical research, including clinical studies, clinical trials, studies, research, trials, and protocols. Clinical research may have a number of goals, such as developing new treatments or medications, identifying causes of illness, studying trends, or evaluating ways in which genetics may be related to an illness.

Strict rules for clinical studies have been put in place by NIH and the U.S. Food and Drug Administration (FDA). Some studies involve promising new treatments that may directly benefit participants. Others do not directly benefit participants, but may help scientists learn better ways to help people.




Clinical Research Phases


A Phase One Study:
Phase I studies focus on assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers, who are usually paid for participating in the study. 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. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing.

A Phase Two Study:
Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies.

A Phase Three Study:
In a phase III study, a drug is tested in several hundred to thousands 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 ninety 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 FDA approval for marketing the drug.

Post-Marketing -- Late Phase Three/Phase Four Studies:
In late phase III/phase IV studies, pharmaceutical companies have several objectives than can include comparing a drug with other drugs already in the market and/or looking at a drug's long-term effectiveness and impact on a patient's quality of life. Many studies are also designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.




Who will take care of me during a clinical trial?


Your study-related care is provided by a team led by Dr. Lucas, Dr. Goldsby, registered nurses, research coordinators and other medical professionals.




How is my personal information and my health protected?


Your identity and other personal information, including that which pertains to your health, medical care and study participation, are protected according to the regulations set forth by both the United States and Texas state governments. *These rules do permit the sharing of some of your information with the research sponsor and certain government officials under very specific circumstances. This allows the sponsoring organization to consult with us about the progress and result of the study and also contributes to the protection of both your health and privacy during your participation. Research organizations are also subject to inspections by the FDA and the research sponsor, and to questioning by Institutional Review Boards and Data Monitoring Committees. Confidentiality regulations apply in these situations. There are also other legal and ethical guidelines that must be followed by medical professionals as well as their office staff.

In addition, we are required by law to provide you with detailed information about the study so that you may give your “informed consent” to become a study volunteer. These details will discuss study purpose, procedures, duration, possible risks and benefits, protection of your health and privacy, optional health treatments that you may wish to consider, treatment of any health problems that could be encountered as a result of study participation and other important information.

*For more information about medical privacy regulations, please visit this link.




Will there be any cost to me to participate in a clinical trial or will I be compensated for my participation?


There is no cost to participants in a clinical study. All medical care, medications and equipment related to the research investigations are provided at no charge. Most participants are paid to help assist with the costs of traveling to and from office visits.




Can I withdraw from a study or must I continue to participate until it ends?


You may discontinue participation at any time for any reason. The informed consent document that you must sign is not a contract and does not state that you must remain in a research study. You may be offered suggestions about how to leave the study, especially if trial medication needs to be stopped gradually or you need to return study medication or other materials.




Will the study team continue to take care of me when the research ends?


Although the majority of our clinical trial participants come from within our large private practice, there are some who come to us via referral from external sources. Those participants may choose to continue care with their previous or current mental health professionals.