Keynote Message

A good quality evidence base for clinical practice requires the conduct of multicentre studies. The major advantages of multicentre studies include the ability to recruit large numbers of patients in a relatively short time period, to conduct studies less biased by the effect of individual centres, and to conduct studies with results generalizable to a larger population of patients. Multicentre studies inevitably involve numerous diverse investigators recruiting patients. In order for such studies to be successful, they should be conducted according to a clear and ideally simple protocol that is agreed by all investigators prior to initiation, including, if necessary, stipulation of methods of measurement of clinical variables. Ethical considerations relevant to all investigating centres should be considered and clearly addressed. Recruitment of patients should be according to criteria that are simple to measure, clear, ideally widely available and agreed by the relevant specialist community as capable of identifying the group of patients of interest. Studies should have a clearly defined primary aim and only a limited number of secondary aims. Analyses of data that will be acquired should ideally be pre-planned. There should be a clear discrimination between information that is "must have" and information that is "nice to have." Minimise the acquisition of data that is not necessary to achieve the primary aim of the study. This will prevent participation in the study becoming onerous and will limit the cost. Large studies are likely to require significant funding which often necessitates the involvement of a commercial sponsor. Where such a sponsor is involved, the needs and aims of the sponsor should ideally be aligned with those of the investigators. Investigators need to maintain sufficient independence from the sponsor for the study to retain credibility. A right to publish, independent of study outcome, should ideally be agreed to allow negative as well as positive studies to enter the literature. When results have been obtained, investigators have a responsibility to ensure those results enter the public domain and are disseminated appropriately.

Key References

1.  Boswood A, Häggström J, Gordon SG, et al. Effect of pimobendan in dogs with preclinical myxomatous mitral valve disease and cardiomegaly: the EPIC study - a randomized clinical trial. J Vet Intern Med. 2016;30:1765–1779.

2.  Häggström J, Boswood A, O'Grady M, et al. Effect of pimobendan or benazepril hydrochloride on survival times in dogs with congestive heart failure caused by naturally occurring myxomatous mitral valve disease: the QUEST study. J Vet Intern Med. 2008;22:1124–1135.

3.  Summerfield NJ, Boswood A, O'Grady MR, et al. Efficacy of pimobendan in the prevention of congestive heart failure or sudden death in Doberman pinschers with preclinical dilated cardiomyopathy (the PROTECT study). J Vet Intern Med. 2012;26:1337–1349.

4.  Sackett DL. The tactics of performing therapeutic trials. In: Haynes BR, Sackett DL, Guyatt GH, Tugwell P, eds. Clinical Epidemiology: How To Do Clinical Practice Research. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2006:66–172.