The VOHC® Seal of Acceptance

Submission to

VOHC -

Format and

Process

  
This document describes how to prepare a submission for VOHC review following completion of the required trials. For details of the VOHC protocol and trial requirements, click Protocols.

One printed copy of the submission is required, which is to include a check for the submission fee, made out to "American Veterinary Dental College". For a list of VOHC fees, click Fees.

Samples of the product (20 samples of individual treats or devices or one bulk package of a dietary product) are to be included with the submission.

In addition to the printed copy noted above, the submission is to contain an electronic copy of the items listed below, sent to the VOHC Director either on a CD or as e-mail attachments.

Order of Items in a Submission

1. A cover letter that includes the name of the specific product(s) and the specific claim(s) [plaque and/or calculus] requested for VOHC review. The cover letter is to be signed by the responsible official of the submitting company, and is to indicate to whom VOHC correspondence regarding the submission is to be sent.

2. An affidavit, signed by the primary investigator and by the responsible official of the sponsoring company, stating that the information submitted is complete and true.

3. A brief description of the product, including the method(s) by which it achieves its effectiveness as an anti-plaque and/or anti-calculus agent, the population of animals for which the product will be marketed, and any instructions or limitations for use of the product that will be stated on packaging or in advertising (such as recommended frequency of use, minimum number or amount of product to be used).

4. A description of the protocol used in the trials, including:

• Primary investigator and statistician (include a brief [maximum one page] summary of relevant training and experience of these individuals - a detailed curriculum vitae is not required).

• Description of the dental indices used, with references to prior published use of the indices or, as an addendum, a rationale for use of a previously unreported index.

• Randomization process used to assign individual animals to the trial groups.

• Data and Statistical analysis methods used, in sufficient detail so that the VOHC statistician could repeat the analysis. The electronic copy of the submission is to include the individual animal data from the trials in spreadsheet format.

For each trial:
A. Site and start and end dates of the trial.

B. Personnel involved: Investigator, supervising veterinarian and scorers if different from the investigator, including a brief summary of relevant training and experience of the scorer(s) (maximum one page).

C. Management of the animals during the trial: Brief description of the care of the animals including housing and diet (with confirmation that the diet fed to the control group was a commercially-available AAFCO-approved dry food diet fed dry), plus confirmation of animal care review procedures for laboratory-housed animals (e.g. IACUC, AALAC approval or certification).

D. Identification (including age, breed, sex and ID # or name) of individual animals, listed with group assignments.

E. Results, as tables showing mean mouth scores for each group at each time point with standard deviation, plus a summary table showing the % difference between groups and a paragraph or table describing the results of the statistical analyses. If the submission is for both plaque and calculus claims, include separate tables of results and analyses for each claim.

F. A statement that the trial was completed as per the protocol, or describing any out-of-protocol events.

The individual tooth scores and mean mouth scores for each animal (in PC electronic spread-sheet format on CD) are to be included in the electronic copy of the submission.

5. Indication of any areas in which the submission does not meet specific VOHC requirements, with reasons why VOHC should consider such departures from its stated policies or requirements. This could be anything from a notation that one animal was missing one of the recommended teeth, to use of an entirely new method of scoring plaque or calculus.

Feedback on the VOHC system and suggestions for improvements in the VOHC process are welcome. Contact VOHC.

Statistical Analysis Information

Statistical Presentations for Inclusion in VOHC Submissions

One of the most common reasons for concerns being raised about a submission during review by the VOHC Council and Statistical Consultant is failure to use and adequately describe appropriate study design and analysis procedures to demonstrate that the VOHC statistical hurdles have been met.


Use of inappropriate study design and/or analysis criteria can be an expensive mistake if the trial has to be repeated. VOHC strongly suggests pre-trial consultation with a qualified statistician. It is the responsibility of the sponsor to ensure that appropriate methods are used.


Requirements for the statistical methods and results sections in the submission:


1. Provide a clear description of the statistical analysis methodology employed, with justification for choice of the specific tests used. The tests used must be appropriate for the type(s) of data (categorical, ordinal [ranks] or continuous [actual metric]) analyzed.


2. Note that there is a risk when using a small sample size (fewer than 30 animals per group, as is typical in VOHC trials) that the data may not be amenable to parametric analysis. Again, for small samples (as just defined), if the group sample variances are greatly disparate (ratio > 2:1), assume the data are not treatable by a parametric approach and apply a non-parametric test (such as Wilcoxon Rank-Sum test) instead of the t-test. Note: there are rank tests for several groups, even when stratified or blocked, to replace ANOVA when necessary.


3. Use a two-tail test when determining p-level.


4. Randomization of subjects to treatment groups is required. The randomization method must be described, and can be used to your advantage. For example: if subjects


are assigned to treatments within a blocking structure (to reduce variability), the blocks can be included in the analyses to reduce the size of the residual error term (i.e.: the denominator of the F-Test).


5. Tabulation of the results of the statistical analyses is required in order to assess the validity of the claim made in the submission. For example: when analyses of variance are used, ANOVA tables are to be presented, including mean squares, F- tests and p-levels. When multi-way layouts are used (for example when various centers are used) the interaction of treatments with the other levels used must be evaluated to insure additivity (that the treatments compared are consistent across the other levels employed in the design).


6. Where several groups are compared, adjustment for type-error must be applied, i.e.; for multiple comparisons.


7. In trials using a cross-over design, effects for carry-over (sequence effect) and period must be included and evaluated in the applicable ANOVA tables. In the event of a statistically significant sequence effect in a 2 period cross-over, only the first period data can then be used in a parallel analysis – the second period data must be ignored. In cases of cross-over designs with 3 or more periods, statistical protocols are available to adjust for carry-over effects detected in the analysis.


8. A descriptive summary table with sample sizes, means with standard deviation and standard error, percentages differences in means of the analyzed variable (e.g. plaque or calculus [tartar]) and where applicable, p-levels for the statistically significant findings, must be included.


9. An electronic copy of the raw data in spreadsheet format (including a clear explanation of the data formatting) is to be included. Including the individual tooth data in the main submission document is not required – in the main submission document, include only the data and analysis information required in items 1-8 above.

VOHC Process Following Receipt of a Submission

1. A preliminary review is performed by the VOHC Director to determine whether the submission is complete. Incomplete submissions are returned un-reviewed by Council.

2. A detailed review is conducted by the VOHC Director, who prepares a report.

3. A detailed statistical review is conducted by the VOHC Consultant Statistician, who prepares a report.

4. The submission, with the Director and Consultant Statistician reports, is reviewed by all Council Members. Comments from individual Council Members are collated by the Director, and circulated to Council.

5. Council Members vote whether to award the Seal, to request clarification of specific items, to reject the submission, or to hold the decision for discussion at the next meeting of the Council.

6. If Council votes to award the Seal, the recommendation is forwarded to the Board of Directors of the American Veterinary Dental College for ratification.

7. When the AVDC Board of Directors has ratified the recommendation from Council to award the VOHC Seal to a product, an Agreement is signed by the product sponsor and VOHC. When both parties have signed the Agreement, the VOHC Accepted Seal may be used on the product and product advertisements. The Agreement requires that the company provides packaging and advertizing materials to VOHC for review of the wording of dental claims. Contact VOHC to obtain a copy of the current Agreement.

8. Whenever practical, Council communicates electronically. The Council holds one meeting regularly each year, during the Veterinary Dental Forum.

 

Time Required for Review and Decision by VOHC

In the absence of any major problems identified by Council during review of the submission, a company can expect to be informed of the VOHC decision approximately twelve weeks from the date of receipt of the submission by VOHC.

 

 

© VOHC, 2008