Clinical Trials

This section will provide answers to common question about clinical trials (CTAs).  If you have a question not addressed here, please contact:

Caitlin Vinyard, CRA
Email: Cvinyard@salud.unm.edu or HSC-PreAward@salud.unm.edu
Phone: (505) 272-4678 or (505) 272-9383

Hengameh Raissy, PharmD - Interim Vice President for Research at UNM Health Sciences
Email:  HRaissy@salud.unm.edu

 Clinical Trial Lifecycle

A Clinical Trial, as defined by NIH, is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  This definition also applies to Pharma related trials in which pharma companies evaluate the safety and efficacy of their developed drugs/devices.  These studies are a necessary requirement to achieving regulatory approval so the drugs/devices can be made available to patients.

What is a Clinical Trial?  How do they get initiated?  How do I get one processed? View the presentation below for guidance.

Clinical Trial Guidance

Ever wondered what SPO looks for while negotiating your clinical trial?  The guide below is to help assist with the understanding of what goes into negotiating a clinical trial and why UNM Health Sciences cannot accept certain terms and conditions.

For the purpose of negotiations; clinical trials will be categorized as follows:

•  Sponsor Initiated - the protocol for the clinical trial has been written by the sponsor (a pharmaceutical or medical device company)

•  Investigator Initiated - the protocol was written by an investigator

Contract negotiations for clinical trials can be difficult and complex. In addition to the customary terms and conditions of a research agreement, a clinical trial agreement will also address various regulatory compliance issues as well as those dealing with subject safety. The sponsor may also hire a clinical research organization {CRO) to manage their contractual process which can lead to the negotiations taking additional time to reach mutually acceptable terms as the CRO must send to the Sponsor for review and acceptance.

Clinical Trial Flowchart

This flow chart shows the flow of clinical trials with the HSC.

CTA Presentation

Additional Information regarding Federal Clinical Trials can be found here: https://grants.nih.gov/policy/clinical-trials/definition.htm

Additional Information regarding ALL Clinical Trial Research can be found here:  https://www.fda.gov/patients/learn-about-drug-and-device-approvals

Clinical Trial Phases

• Phase I trials: Researchers test a drug or treatment in a small group of people (20-80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects.

• Phase II trials: The new drug or treatment is given to a larger group of people (100-300) to determine its effectiveness and to further study its safety.

• Phase Ill trials: The new drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely.

• Phase IV trials: After a drug is approved by the FDA and made available to the public, researchers track its safety in the general population, seeking more information about a drug or treatment's benefits, and optimal use.

Please refer to the NIH website for more information.

Clinical Trial Budget

The attached will describe the main costs associated with clinical trials and what must be included.  SPO does not negotiate clinical trial budgets.  This is done by the PI directly with the sponsor.  SPO does not have the in-depth clinical knowledge to accurately represent what the PI needs.  SPO DOES negotiate the Clinical Trial Agreement by reviewing for a safe and fair agreement.

Early Termination Process for Clinical Trials
Guidance on how an early term is processed.

CTA Budget

If you need additional assistance with your CTA Budget, contact:

Who Are The Protocol Registration System (PRS) Administrators?

The Protocol Registration System (PRS) Administrators for ClinicalTrials.gov are:

OfficeOfResearch-ClinicalTrials.gov@salud.unm.edu

505-272-2021

To see a list of organizations with PRS accounts, please visit the clinicaltrials.gov "PRS Orgs" page

What Are The Patient Care Rates For UNMH?

• The cost of UNMH procedures on any federally-funded, investigator-initiated / research allocation committee (RAC) internal, state-sponsored, or non-profit foundation agreements is 100% of the Medicare fee (including deductibles and co-insurance) that the hospital would receive if the service was performed for a Medicare beneficiary.
• The cost of UNMH procedures on any industry-sponsored (pharma and for-profit) agreements is 140% of the CMS rate.