Office of Clinical Research
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What is clinical trial?
A clinical trial is type of research or study to test new medical ideas, treatments and therapies that may involve experimental drugs, device or biologics.
What are the advantages of clinical trials?
- Access to newer and more effective treatments that aren’t otherwise available.
- Helping to improve medical knowledge that may help others in the future.
What are the disadvantages of clinical trials?
- Possibly experimental treatment in addition to standard treatments.
- Some side effects may not be known.
- Sometimes you may get placebo (inactive ingredients) or unknown treatment group.
- The new treatment may turn out to be no better than standard treatment.
Does my information remain confidential and private?
Your information is only disclosed to the researchers and their affiliates like sponsors and labs. Controls are in place to ensure none of your information is released without your permission.
What trial can I participate in?
It depends on a few factors: if the trial is relevant to your medical needs, if the trial is currently enrolling new participants, if you passed screening or are eligible, and if the benefits outweigh the risks for you.
Will I be getting a placebo?
Placebos contain inactive ingredients. Not all studies use a placebo. Always ask your doctor and review the consent form.
Who makes sure the experimental drug or device is safe?
There are results from prior test that must be provided to the Food and Drug Administration before it grants approval to begin human tests. Besides that, a group of medical and non-medical people (called institutional review board - IRB) must decide if the experimental agents are safe for people where the research will occur.
What if I change my mind afterwards?
It is your right to leave the study without any penalty at any time you choose by informing the research team.
How much does it cost?
Many times costs are covered by grants or funds from the trial sponsor. Each trial is different, so it’s best to check with the research team before enrolling.
What happens after the clinical trial?
After a clinical trial is over, the researchers carefully examine all the information gathered and make decisions about the meaning of the findings which may lead to new and improved treatments and therapies.
Below are some things we want sponsors and our collaborators to know about our commitment to clinical research:
- Since the early 1980s
JPS had pockets of research at various medical departments since the 1980s. Those pockets of research have now coalesced under the Office of Clinical Research (OCR).
Providing research as an alternative to care is deeply rooted in the vision and mission of the leadership structure, compliance committees, physician groups, and operational fabric of JPS.
- JPS Foundation
The JPS Foundation though an independent entity has partnered with OCR to facilitate acquisition of research and quality improvement grants. The Foundation has supported the effort to study the COVID-19 pandemic local impact on the community at large.
- Behavioral Health
The Behavioral Health group at JPS provides a full continuum of behavioral health services, including inpatient services at Trinity Springs Pavilion, emergency behavioral health services at the Psychiatric Emergency Center, and outpatient services at JPS outpatient clinics. These expansive services has led to a robust research program at Behavioral Health.
- JPS Oncology & Infusion Center
JPS has acquired a new cancer facility with ample space for clinical trial endeavors. The fight to subdue cancer via innovative therapeutic measures by our pharmaceutical and biotechnology partners has been amplified.
- Collaboration with Local Medical Startups
OCR is actively collaborating with small medical start-ups in the Dallas/Fort Worth area for example, on Proof of Concepts, small Phase II clinical trials and bio-specimen collection for validating diagnostic equipment.
- JPS True Worth Medical Home
True Worth is pioneering effort to making JPS provide routine medical care to the homeless population, and be a national leader in studying the impoverished population and how to combat homelessness and other socio-medical factors.
- Virtual Biobank
OCR is working closely with some leader-of-the-pack virtual biobanks to help with bio- specimen collection from the diverse pool of our patient population for cutting edge research.
- Partnership with HSC
JPS has partnered with University of North Texas Health Science Center to form a regional Institutional Review Board (IRB) called the North Texas Regional IRB. This board has served the research review needs for JPS since 2017.
- Commercial IRB
OCR currently has numerous studies with AAHRPP accredited commercial IRBs. Reliance agreements are relatively easy to execute.
- Medical Residents and Students
JPS Health Network is a national leader in medical residency and medical students training. These programs facilitate scholarly activities including clinical research.
- Research Savvy Legal Counsels
OCR works closely with corporate legal counsel, and also routinely requests the expertise of a woman-owned health sciences law firm that specializes in clinical research. This ensures speedy legal review for CTAs and other legal documents.