Abstract
Randomized clinical trials, and cross-sectional, case control and cohort studies form the foundation for evidence-based medical decisions in human and veterinary medicine. Robust study designs, however, are only effective if recruitment strategies successfully achieve an unbiased study sample and an adequate number of subjects. Successful recruitment actually forms the mechanism that moves an entire trial forward; ironically these strategies often do not receive adequate consideration during a trial’s design phase. Instead, focus is directed heavily toward inclusion criteria, protocols and outcome measurements.
Time invested with the owner builds trust and facilitates an informed client decision, which is fundamental for a clinical trial
Inattention to recruitment will severely threaten study validity, budget, timely publication and ultimately the integrity of evidence-based medicine. To help guide recruitment strategies and maximize enrollment and retention of study subjects investigators must understand what influences potential clients to participate, as well as track previous participation rates and reasons for declining participation. These are factors that will allow successful recruitment methods to be defined. 1
In this issue of JFMS, Dr Margaret Gruen and colleagues at North Carolina State University report a cross-sectional survey to help unveil influences and preferences among cat owners potentially considering clinical trial participation. 2 The three most important factors identified were trust in the organization performing the trial, followed by benefit to the cat and veterinarian recommendation. Engaging the primary care health team throughout the research process establishes trust and ultimately influences client recruitment. Primary care veterinarians may be more likely to recommend trial participation when a trusting relationship exists between the research institution and the practice. To establish this relationship and create a sense of collaboration, investigators must reach out to primary care health teams and discuss the role of clinical research as well as address questions and concerns about study protocols. They need to highlight the deficiencies in current medical knowledge and explain how the proposed study will contribute to the field, ultimately leading to better treatments for all patients. Importantly, too, they need to acknowledge the importance of the primary care team’s contribution to a successful trial.
The process of informed client consent is one of the most fundamental aspects of clinical trials. Researchers have an ethical and legal responsibility to allow individuals the opportunity for an informed, non-coercive, voluntary decision to consent or decline enrollment. In our own experience of running trials, albeit with dogs, the recruitment process is best received when a substantial amount of time is invested with the client. This creates an inclusive atmosphere, builds trust, and allows the opportunity to educate and encourage an informed client decision. It is mandatory that study personnel are trained to present all aspects of recruitment eligibility, trial procedures and participation, risks, benefits, confidentiality, financial responsibility and completion incentives. 1 Based on the survey results in Gruen’s study, emphasizing potential benefits to the cat may encourage client participation. In some areas, it has been shown that study participation in itself has a positive effect on outcome compared with non-participation, possibly due to the increased investment in study participants (so-called ‘trial effect’). 3
Gruen’s survey also revealed that clients are more likely to consider study participation for diseases that have personally impacted their own cats. An interactive recruitment process may provide the opportunity to make this connection, if it exists. In contrast, clients are much less likely to participate if the trial involves an experimental, unproven procedure or if there is a risk of discomfort to the cat. Ethically these points must be disclosed and openly discussed; notwithstanding, a trusting relationship or veterinary recommendation may lead some clients to reconsider participation. Survey respondents also identified free services as the preferred type of incentive, with financial compensation and gifts for cats included in the top three preferences. Likewise, we have experienced that incentivization is appreciated by owners and appears to increase study participation.
Although Gruen’s study recognizes response differences between those that indicated they would, would not, or were unsure about clinical trial participation, it does not explore specific preferences of the would not group. Non-participation bias is important to consider as it is a form of selection bias in which differences exist between individuals choosing to consent or decline study participation. Unfortunately, these differences are often difficult to assess but have the potential to greatly affect external validity (ie, the ability to accurately generalize study results to the larger patient population).4,5 Another aspect of recruitment that institutions would do well to consider when developing a clinical trial policy is the involvement of owners in the development phase of clinical studies. Community participation in health and medical research has been shown to have many advantages – providing accountability, communication and transparency, identifying priorities and concerns that were not initially recognized by the researchers and forming a strong, collaborative relationship between the community and the research organization. 6 Giving a voice to the owners through an owner advocacy group and a dedicated clinical research liaison officer will make clinical research more efficient, effective and relevant.
Dr Gruen and her colleagues are to be commended for undertaking this work; it is invaluable to understanding important factors that may attract or deter client participation in clinical trials. Ultimately, this impacts the integrity of evidence-based medicine.