Transparency of potential bias
Identifying bias is also important. Readers should be aware of a study's source of funding. As mandated by the Food and Drug
Administration (FDA), manufacturer-sponsored studies that support drug approval generally test hypotheses that the manufacturer's
product is not inferior to a positive control, rather than generate unique information. Frequently, only those reports in
which their product performs well make it to peer-reviewed literature. Reports of studies sponsored by manufacturers should
be considered biased but not necessarily suspect.
Need for greater practitioner participation
Although it is the investigator's responsibility to design clinical trials that provide valid conclusions, often the best
design is circumvented by lack of practitioner participation. However, as clinical research continues to struggle for acceptance
in academia, the role of practitioners becomes increasingly important. Practitioners have historically provided the patient
base for industry-based clinical trials, and private practitioners are best-positioned to assume a leading role in implementing
As a clinical pharmacologist, I have concentrated on clinical research. Our laboratory has implemented a number of clinical
trials, often in partnership with private practices. I am humbled by the care and attention to detail that participating practitioners
and their clients dedicate to our studies. However, some participants fail to follow study protocols, not realizing that doing
so excludes that patient's data from the study and reduces the sample size.
Furthermore, we have difficulty identifying potential participating practitioners and clients. For example, we have three
ongoing clinical trials, two that involve compounded preparations (including transdermal gels) and one that investigates antimicrobial
resistance. Practitioners enthusiastically agree that the medical information to be generated by the successful implementation
of these studies will meet practitioner and patient needs, yet we have not identified sufficient participants.
Practitioners express several concerns regarding participation in clinical trials, some of which can be resolved by improving
investigator and participant communication. Other concerns require that practitioners take a more altruistic approach to generating
new knowledge. At least three approaches might increase patient recruitment.
Ensure simple guidelines and thorough informed consent. Investigators must clarify and simplify guidelines that participants must follow so practitioners can and will take time
to collect data correctly. In addition, the informed consent must be clear and complete since practitioners or their clients
may also be concerned that patient health is put at risk. As little as 10 years ago, informed consent was basically a permission
slip the owner signed to allow a pet to participate in a study. Today, the client informed consent describes, in lay terms,
all procedures, risks (including possible placebo assignment or a description of any potential adverse events), benefits that
directly affect the patient, confidentiality, and client costs of participating. A well-designed informed consent should also
identify alternative therapies should the client choose not to participate and guarantee that choosing not to participate
will not alter the level of care the pet might otherwise receive.
Practitioners might approach the informed consent as an opportunity to guide clients through the decision-making process and
present the clinical trial as a therapeutic option that is not available through other venues. However, the fully-informed
client should make the final decision regarding participation, thereby reducing practitioner risk.
If a study is blinded and precludes clinician knowledge about which therapy patients receive, fail-safe procedures (described
in the informed consent) should be in place that allow codes to be broken (ending the study) if patient health is at risk
for any reason. Practitioners might also be concerned about the continued availability of successful therapies once the study
ends. The informed consent should address means by which therapy can be continued, if desired, and the anticipated client
cost of continued therapy.
Consider alternative reimbursement for participation. Practitioners also are hesitant to dedicate their limited time to participation in a clinical trial. Financial reimbursement
for participation is not unreasonably expected; certainly, physicians are compensated, as are practitioners participating
in industry-sponsored field trials. Perhaps this is where the altruistic side of veterinary medicine might emerge: Colleges
and private foundations that fund clinical trials in animals often cannot afford reimbursement for veterinary participation.
Some innovative approaches to rewarding practitioners such as coauthorship (if appropriate), acknowledgments in the reports,
or providing certificates of contribution suitable for display might encourage more participation.
Help develop and use a recruitment database. Among the biggest obstacles to patient recruitment for veterinary clinical trials is adequate promotion of trials available
to animals. Human clinical trials recruit patients through media as diverse as magazines, subway walls, and Web sites. People
can search the Web for clinical trials that target their ailment. In veterinary medicine, few means exist for shared communication
regarding clinical trials. Each academic clinical trial center lists its ongoing studies on its Web site, and VIN members
can communicate about studies, but the net thrown out to identify potential participants is limited in size and scope.
A centralized veterinary clinical trial Web site that matches investigators, trials, and patients is paramount to the continued
growth of evidence-based veterinary medicine. Our profession is too small, funding is too limited, and the need for clinical
trials is too great for an otherwise well-designed clinical trial to fail because of a lack of sufficient study participants,
particularly if eligible patients exist. Such a Web site, which should provide the service at no or minimal charge, might
also include a frequently updated description of ongoing or finished clinical research studies and, as deemed appropriate
by investigators, updated results.