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Clinical Trials at UC Davis Health System

Clinical Trials at UC Davis Health System

NEW! UCSF offers a referral for Pre-Clinical CROs

UCSF’s Clinical and Translational Science Institute has assessed and pre-selected a number of Contract Research Organizations (CROs) that offer a broad range of key research services. The CROs have been chosen on the basis of their proven technical expertise, flexibility, past experience in working with academic investigators, and price. UCSF offers a referral service to UC Davis investigators.

Currently pre-selected CROs offer a broad spectrum of expertise and services, including (but not limited to):

  • High-throughput screening
  • ADME (in vitro and in vivo)
  • Pharmacokinetics and pharmacodynamics
  • Toxicology (including GLP tox)
  • Bio/analytical services
  • Medicinal Chemistry and custom synthesis
  • GMP manufacturing
  • Preclinical disease models
  • Biocompatibility (for device development)

Additional CROs with device development expertise are currently being identified.

To get connected to a CRO, see UCSF website or contact Irina Gitlin (irina.gitlin@ucsf.edu or 415-514-8510).

A Primer on Preclinical Testing Requirements (based on the seminar "Essential IND Strategies - Fundamental Considerations on the Road to Sucess," October 2013)

ICH Guidance M3: Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

ICH Guidances S(Safety): Required Studies for specific Endpoint Assessment 

ICH Guidances Q(Quality): Analysis, characterization (small molecule and biologics), impurities, GMP, quality systems, risk management.

 

 

NEW! FDA GUIDANCE ON WHETHER IND IS REQUIRED

 

 

Participate in a free FDA educational activity entitled, The Past, Present, and Future of FDA Human Drug Regulation."

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Have questions about Drug Development and Investigational New Drug Applications? FDA provides  Answers to Frequently Asked Questions. Example questions include: what are the FDA requirements for pre-clinical studies? What is an Investigational New Drug Application?

"Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies can be Conducted Without an IND."

This guidance (dated September 2013) replaces an older guidance last updated in 2010. The updated guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and IRBs in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND). In general, the IND regulations require that human research studies be conducted under an IND if a) the research involves a drug, b)the research is a clinical investigation, and c)the clinical investigation is not otherwise exempt from IND requirements. For questions or help determining whether your study needs an IND please contact CTSC Clinical Trials Resource Group.

Other FDA Guidances on similar subject:

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

Procedures for Handling Inquiries Regarding the Need for an Investigational Device Exemptions Application for Research Involving Medical Devices

Contact CTSC Clinical Trial Resource Group for assistance with IND/IDE submissions and communications with the FDA.

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Expanded Access to Investigational Drugs

Expanded Access or compassionate use is the use of investigational drug outside of a clinical trial for the sole purpose of treating a patient or patients with serious or life-threatening disease who have no acceptable medical option. Serious diseases or conditions are those associated with morbidity that has a substantial impact on day-to-day functioning. Whether a disease is serious is a matter of clinical judgement. Examples cited by FDA include epilepsy and in situ breast cancer.

Expanded Access includes three options:
• Treatment IND
• Group C treatment IND
• Emergency Use IND

Download the comprehensive summary here

NEW! 2013 Draft Guidance
Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers:

  • Who can make a submission? 
  • What are the roles of the patient’s physician and FDA ?
  • When should individual patient access be requested?
  • When can emergency use access begin?
  • And more....

Listen to the FDA Webinar on Expanded Access (February 2010)

 

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Regulations Affecting Investigational Devices

From Idea to IDE. This video provides a brief overview of how a medical device begins with an idea and ends with its submission to FDA,  and highlights aspects of the  IDE process.

If a product is labeled, promoted or used in a manner that meets the  definitions in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated as a medical device. A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,
    OR
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Download the  comprehensive summary of device classification, regulations, IDE submissions, Humanitarian use designation etc.

Important new FDA Guidance:  Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies (October 1, 2013). Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial  clinical safety data. These studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process. This guidance has been developed to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects in early feasibility studies.

 

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STEP-BY-STEP: Investigational New Drug (IND) and Investigational Device Exemption (IDE)

 

Overview of Sponsor-Investigator Responsibilities

Investigational New Drug (IND)                                                                                                    Investigational Device Exemption (IDE)                                                                                            

As a consequence of  increased volume  of investigator-initiated clinical research involving drugs and/or devices, there are numerous institutional considerations to ensure that investigators and their research staffs are appropriately equipped to manage all aspects of the regulatory responsibilities and obligations associated with initiating and conducting such research.

The materials on this website are made available by the members of the CTSA IND/IDE taskforce.

1.   Investigator Responsibilities inder IND/IDE (Tracy Hysong, CCRP, Regulatory Analyst IV, CTSC)

2.    Sponsor and Investigator Responsibility checklist with supporting documents (Partners Human Research Quality Improvement (QI) Program)

3. Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators (M. E. Blair Holbein, PhD, J Inv Medicine (2009), v. 57, n. 6, p. 689-695).

 Develop the protocol       

   Determination of IND Exemption  

 Submit to IRB

 File an IND 

 Receive an IND number 

 Amendments   

 Safety Reports  

Annual Reports  

 Develop the Protocol   

 Determination of SR/NSR               

   Submit to IRB 

   File an IDE  

   Receive the IDE Approval

   Supplements 

 Progress Reports   

Safety Reports