Clinical Trials

Policy

The New Zealand Veterinary Association accepts the need for veterinarians to conduct clinical field trials to evaluate appropriate management and therapy but only if all ethical and legal obligations are met.  Protocols used in such trials must contribute to a better understanding of animal production and/or health.

Definitions

a) Ethical Obligation

The Code of Professional Conduct for Veterinarians, 2000, states, amongst its guiding principles of professional conduct, that:

• Veterinarians have a special duty towards animal welfare and to alleviate animal suffering. They must be conversant with the provisions of the Animal Welfare Act 1999 and any Codes of Animal Welfare relevant to their field of endeavour; and
• Veterinarians must be conversant with and abide by all statutory requirements affecting them individually in their various professional roles and take every reasonable step to ensure their observance by others.

b) Legal Obligation

Under the Animal Welfare Act 1999, section 82, no person may carry out research, testing or teaching involving the use of animals unless that person holds an approved Code of Ethical Conduct, or is employed by such a person for the purpose of carrying out research, testing and teaching.

Research, testing and teaching is defined in Section 5 of the Act as any work that involves the manipulation of any animal, whether for the purposes of research, for producing antisera or other biological products, or for teaching, but a specific exclusion is made for veterinarians where manipulations fulfil certain criteria.

Manipulation is taken to mean interfering with the normal physiological, behavioural, or anatomical integrity of the animal by deliberately:

• Subjecting it to a procedure which is unusual or abnormal when compared with that to which animals of that type would be subjected under normal management or practice and which involves:
  • exposing the animal to any parasite, micro-organism, drug, chemical, biological product, radiation, electrical stimulation, or environmental condition; or
  • enforced activity, restraint, nutrition, or surgical intervention; or
  • depriving it of its usual care;

This definition does not include any therapy or prophylaxis necessary or desirable for the welfare of the animal.

Explanation

Exclusion for veterinarians carrying out clinical trials:

• Given that clinical response trials may be the best way of establishing appropriate therapy or management practice, the definition of research and testing specifically excludes any manipulation that is carried out on any animal that is in the immediate care of a veterinarian, if:
  • the veterinarian believes on reasonable grounds that the manipulation will not cause the animal unreasonable pain and distress, or lasting harm; and
  • the manipulation is:
    • for clinical purposes in order to diagnose any disease in the animal or associated animal; or
    • for clinical purposes in order to assess the effectiveness of a proposed treatment regime for the animal or any associated animal; or
    • for the purposes of assessing the characteristics of the animal with a view to maximising the productivity of the animal or any associated animal.
• An “associated animal” means, in relation to an animal that is manipulated, an animal that:
  • is of the same species and is from the same flock, herd, or other group as the animal that is manipulated; and
  • is in the immediate care of the veterinarian who carries out the manipulation.
• The term “in the immediate care of the veterinarian” is defined in the Code of Professional Conduct for Veterinarians, 2007, as meeting the following conditions:
  • the veterinarian must have been given and accepted responsibility for the health and welfare of the animal; and
  • the provision of ongoing and continuing care or the animal is a reality and not merely nominal. Evidence of care that was ‘a reality’ would include the keeping of a file recording details of that animal’s care and/or the care of other animals in the same herd or flock;
  • either:
    • the animal, herd or flock must have been seen immediately before prescription and supply; or
    • the animal, herd or flock must have been seen recently enough or often enough for the veterinarian to have personal knowledge of the condition of the animal or current health status of the herd or flock in order to make an informed diagnosis and prescribe appropriately.
  • The veterinarian must maintain adequate case records detailing any treatment regime clinical records of that animal, herd or flock;
  • Inherent in prescribing PAR veterinary medicines is the ability and commitment to provide adequate emergency care should that be necessary, given the circumstances of the case and potential for adverse effects from or failure of the prescribed PAR veterinary medicine(s). A veterinarian must either:
    • Provide emergency care personally; or
    • Make arrangements for another veterinarian to provide the care.
  • Provision of, or arrangements for, immediate care must be available at all times.

Guidelines

1. Obtaining samples from normal animals without causing any significant discomfort, pain, suffering, distress or lasting harm to those animals in order to support a diagnosis, or to provide information relating to animal husbandry or clinical management does not require AEC approval. However, if the sample does not fall into these categories but is being taken specifically to obtain information for the trial, AEC approval should be sought.
   The informed consent of the owner is required and sampling must be carried out by or under the supervision of the owner's veterinary surgeon only on animals in that veterinarian’s immediate care.
   Examples:
   1. trace element evaluation by blood testing
   2. comparison of anthelmintics by drenching
   3. weighing
   4. faecal sampling
   5. grazing trials on treated pasture
   6. offering supplements to naturally available food
2. Manipulations of animals, which must be considered by an Animal Ethics Committee established under a Code of Ethical Conduct, are all those which are invasive and/or could cause pain, suffering, distress or lasting harm (as defined under Legal Obligations above).
3. Veterinarians who conduct clinical trials that are not scientifically valid and which do not comply with ethical and legal requirements are acting unprofessionally and are liable to disciplinary action.
4. Scientific validity of information resulting  from clinical trials must be assured by the way in which the trial is designed.  The methodology used in the trial must be such that the knowledge gained is both useful and meaningful.  It is unacceptable to embark on a study or trial that, because of insufficient numbers of animals or faulty design, cannot provide meaningful results. However, when planning trials the number of animals used in a given trial should be the minimum necessary to provide a valid result. Veterinarians who wish to conduct clinical trials are strongly advised to seek the guidance of a biometrician who is competent to advise on such elements of design as power analysis, statistical analysis and significance of results. Names of biometricians who are willing to assist NZVA members are available from the NZVA office or the Epidemiology Branch of NZVA.
5. Use of data gathered from such clinical trials
   • "in house"... the owner of the animals used in the trial to enhance knowledge of production collects the data for use;
   • product claims ... the data are collected as the result of a number of trials in a specific locality and then used to promote that product through the practice newsletter. In this case, under the Fair Trading Act 1992, the claims must be valid and able to be substantiated.
6. Whether ethics approval is required or not, veterinarians carrying out clinical trials should familiarise themselves with Part 6 of the Animal Welfare Act, which is well explained in the MAF Policy Information Paper 33, “Users Guide to Part 6 of the Animal Welfare Act 1999”.

References and relevant legislation

Animal Welfare Act 1999

Users Guide to Part 6 of the Animal Welfare Act 1999, MAF Policy Information Paper 33

McDougall S. Conducting clinical trials in veterinary practice . Vetscript 19(10), 32-33, 2006 at http://www.sciquest.org.nz/crusher_download.asp?article=11001020

Policy Files: 

14a - Clinical trials - 16Mar09.pdf