Before jumping in, take time to think about your trial and it's setting. Consider the following:
- What is the research question?
- How will this clinical trial impact quality of care for future veterinary patients? Human patients?
- To what degree could the study transform diagnosis, treatment or prevention of a disease/condition?
- How will this clinical trial impact:
- UC Davis?
- The Veterinary Medical Teaching Hospital?
- Centers like the Center for Companion Animal Health?
- The public?
- Does this study align with your professional and research goals? UC Davis's goals?
- How will you benefit from the trial (e.g., publications, patents)?
- How will the university benefit from the trial?
Clinical trials often fail to meet their targets because of:
- Inadequate recruitment
- Inadequate budget
- Insufficient investigator benefits
- Time constraints of the investigator
- Inadequate study design
- Inadequate data collection (quality or quantity)
- Lack of statistically significant data
Knowing this, do a feasibility assessment of the trial. Do you have:
- An interest?
- Qualifications and expertise?
- If not, have you established relationships with other UCD faculty members that may be interested and have the expertise/qualifications?
- Do you require other sites to help with the caseload? If so, you will probably need an agreement with them which takes time to negotiate.
- Time to conduct or oversee the trial?
- Think about your clinic duties, teaching, other clinical trials that you have already committed to
- Preliminary Data?
- Qualified personnel?
- Facilities & Equipment?
- Do you need specialized diagnostic or therapeutic equipment?
- Is the equipment available?
- Space and storage?
- Where will you keep samples?
- How will you store them?
- If not, do you think you can get the funding?
- If so, can you get the funding in the proposed time frame?
- Are the inclusion/exclusion criteria too restrictive?
- Is the proposed patient recruitment rate realistic?
Before designing your trial, contact the VCCT. We can help bring your trial to fruition!
A robust trial design is essential to ensure a successful outcome. Consider your design before developing the IACUC/CTRB protocol. This will help ensure that all necessary practical requirements are identified early so that adequate funds are requested.
Successful trials often share similar characteristics, including:
- Conceptually simple and tailored to the patient group
- Address questions of clinical relevance where genuine uncertainties exist
- Avoid unnecessarily complex/restrictive entry criteria to ensure generalizability, where appropriate
- Avoid unnecessarily complex data requirements (resulting from a careful justification of each data point to be collected)
- Ensure robust blinding of intervention or appropriately blinded outcome assessments (where appropriate).
It is important to collaborate with a biostatistician who can help with:
- Designing your trial
- Choosing an appropriate outcome
- Sample size justification
- Advising on appropriate randomization methodology
- Drawing up a statistical analysis plan
- Handling and structuring collected data
Don't have a biostatistician? The European Medicines Agency Committee for Medicinal Products for Veterinary use (CVMP)'s "Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)" (2012) may help!
When designing your trial, think about:
- Type of trial
- Quality of life/supportive care/palliative care
- The clinical outcome
- Standard versus new
- New versus placebo
- Assigning patients to groups
- The material/drug/product:
- Pharmacokinetics and dynamics
- How you will obtain the test material?
- Will you need material transfer agreements? Confidentiality agreements?
- Where will the material be administered (e.g., at the owner's home, clinic)? By whom? How will it be administered (e.g., injection, pill)?
- Does the owner need to worry about their safety after the product is administered to their pet?
- What are the labeling requirements for drugs administered at home?
- Your patient population
- Exclusion/inclusion criteria
- How many animals?
- Do you have the caseload to complete the trial?
- Early mortality of patients (depending on the disease/condition)
- Do you need help beyond your lab?
- Clinical Trials Coordinator, technicians, the VCCT
- What are their schedules?
- Do you need assistance after-hours or on weekends?
- What type of samples do you want to collect?
- How will you collect, store and/or transport these samples? Who will do this?
- Who will analyze the samples? Do you need to coordinate with them ahead of time?
- Where will the trial be run?
- Will treatment need to occur at home?
- Will you need rooms for recovery? Quarantine? Compounding the drug?
- Materials & Equipment
- Disposable (e.g., syringes) and non-disposable materials
- What type of equipment do you need? Is there a schedule to use the equipment? How much will it cost to use that equipment?
- Owner Responsibilities
- How often will the patients have to come in?
- What else will these individuals have to do to have their pet participate?
- Will you be able to pay for some or all of the procedures? If not, what procedures will be covered by the owner?
Clinical trials are typically a major financial investment with a potentially lengthy process to secure the funding. You need to convince funding agencies and foundations that the proposed study is feasible, scientifically valid, and addresses a clear need in the veterinary or human medical field.
Things to consider when searching for funding:
- The time required to secure funding. Look for published schedules of grant submission/review and awards.
- Eligibility requirements of the grant. Make sure you are eligible to apply before submitting your application.
- The funding agency's mission or purpose of the grant. Make sure the purpose of your study and that of the agency/grant are in alignment.
- Involvement of a specific breed or disease/condition. Look for agencies or foundations that focus on those specifics (e.g., Rottweiler Health Foundation)
- The amount of money needed.
Once you have designed your study, it is time to write and submit the IACUC protocol. This protocol is an online application with the instructions embedded in the form. If your study involves animals (VMTH patients or not), you will need an IACUC protocol.
Client-owned, VMTH patients: The owner informed consent document must be attached to your IACUC protocol for review by the CTRB.
Client-owned pets that are NOT VMTH patients: Although you still need to submit an IACUC protocol, you do not have to include the owner consent form. However, if you would like the CTRB to review your consent form, you can either attach it to your IACUC protocol (as you would if you were using VMTH patients) or send it directly to the CTRB Chair for an informal review.
Links to the IACUC protocol and owner informed consent document can be found at the bottom of the CTRB & IACUC page.
If you are planning on having someone that is not affiliated with UC Davis work under your protocol, that individual is required to take the ACU 101 and Occupational Health courses through UC Davis. The individual needs to become a "Temporary Affiliate" to take the required courses and be included on the protocol.
For any projects where money is exchanged (e.g., grant, contract, service agreement), send all documents to the VCCT. We can submit them to the Sponsored Programs Office (SPO) for you to get the negotiation process started! Please provide the following information/documents:
- Proposal, which includes the title
- Scope of Work/Abstract (should include the purpose of the agreement)
- Type of request (Grant, Contract or Service Agreement)
- Type of project (e.g., Clinical Trial)
- Budget justification
- % effort (minimum for PIs is 1-2%)
- Sponsor contact information
- Sponsor deadline
- Project beginning & end date
- Call-for-Proposal request (e.g., RFA, RFP, etc.)
- Any other potentially useful information to forward on to the Dean's Office or SPO during review
For subawards, please provide the information/documents outlined above in addition to the following:
- A letter from the institution receiving the subaward indicating that the institution agrees to the terms and conditions and any required cost share
- Budget and budget justification specific to the subaward. Please be as specific as possible with these documents, outlining exactly what is expected of the subaward. The budget should also include a contingency budget for unforseen endpoints (e.g., the owner drops of the study early, the pet suddenly passes away)
- An institutionally endorsed proposal (complete with scope of work. Please be as specific as possible with these documents, outlining exactly what is expected of the subaward.
- Proposal-specific Subrecipient Commitment Form for subawards using non-Federal Demonstration Partnership (FDP) institutions
- Annual Certification Form (contact the VCCT for a copy)
For any other types of request (e.g., material transfer) that do not involve funding, please contact our office.
Per the VICH "Good Clinical Practices" (GCP) guideline (2000), Ensure that all of the documents associated with your study are organized and easy to find. Documents should be stored properly to avoid any kind of damage or vandalism and published in the final report to the sponsor. It may be easier to create a study binder/laboratory notebook or store everything electronically. Documents to keep include:
- Signed and dated copy of the study protocol and any amendments
- Signed and dated copy of any deviations to the protocol
- Informed Owner Consent form
- CTRB/IACUC protocol and any necessary amendments
- IACUC approval letter
- Any advertisement(s) used for recruitment
- Inventory of receipt, usage, assay results for and disposal of veterinary products
- Signed agreements (non-disclosure or confidentiality, material transfers) with the sponsor
- Raw data
- Animal records (e.g., exclusion documentation, informed consent by the owner, treatment assignment, observations, case report forms, adverse events, health observations)
- Investigational and control veterinary product records (e.g., records of the ordering, receipt, inventory, assay, use/administration, disposal)
- Records of any contact with sponsor (telephone calls, visits, letters, etc.)
- Facility and equipment records
- Reports to the sponsor (e.g., for safety, adverse events, statistical analyses, laboratory tests) including the final study report (FSR)
- Standard Operating Procedures and reference materials
- Regulatory Authorization/Approval/Notification of Protocol (if required)
- Requested laboratory/technical procedures/tests
- Sample labels
- Shipping records
- Certificates of analysis of investigational products shipped
- Decoding procedures for blinded studies
- Master randomization list
- List of individuals who participated in the study
- List of participating sites (as needed)
Things to remember:
- Always include units used to measure observations.
- The individual who observed/recorded the data or who made any corrections to the raw data should initial or sign their name. Any corrections should allow the original entry to still be visible despite the correction (e.g., a single line through the incorrect information).
- Retain all study-related documentation for the period of time required by the sponsor and/or any relevant regulatory authorities. All documentation is subject to monitoring or inspection by the sponsor, so keep the information organized in the event of an audit.