A review of the literature suggests that, broadly categorized, there are protocol, physician, and patient-related barriers to oncology clinical trial recruitment. The latter includes a number of different attitudinal and misconception barriers that are not overcome due to poor quality and unstructured communication between patients and recruiting staff/physicians; recruitment discussions to overcome patient-related barriers are generally not coordinated and managed, and effectiveness is limited to the skills (including language and cultural awareness) of staff at each site. Mills et al (The Lancet Oncology, 2006) in a meta-analysis found patient-related barriers that included: concerns with the trial setting; a dislike of randomization; general discomfort with the research process; complexity and stringency of the protocol; presence of a placebo or no-treatment group; potential side-effects; being unaware of trial opportunities; the idea that clinical trials are not appropriate for serious diseases; fear that trial involvement would have a negative effect on the relationship with their physician; and their physician's attitudes towards the trial. Further, Meropol et al (J Natl Compr Canc Netw, 2007) found that although oncologists and patients are aware of clinical trials and have favorable attitudes toward them, psychosocial barriers exist for patients that may impact participation in clinical trials. Strategies that improve communication will have a positive impact on recruitment, however Fallowfield and Jenkins (European Journal of Cancer, 1999) note that communication within oncology is a core clinical skill but one in which few oncologists or specialist cancer nurses have received much formal training, and communication difficulties may impede the recruitment of patients to clinical trials. The proposed solution focuses on creating a more structured and managed process to carefully, and in a contextually appropriate manner, communicate with potential clinical trial participants.
The most significant obstacle will be physician and staff resistance to a new online channel for patients to communicate, given that there is potential to increase (uncompensated) work load. This can be managed by institutional selection of the most appropriate patients that are permitted access to the Portal, high quality training for all participants, clear guidelines and rules around messaging, as well as ensuring high quality clinical trial barrier educational materials that minimize the follow-up required.
In addition to patient barriers, there are also protocol and physician-related barriers (amongst others). The proposed solution primarily addresses patient barriers, with the potential for overlap into others. The relative contribution from each is unknown, but an improvement in communication and the reduction of patient barriers is likely to have a meaningful impact and should achieve the goal of doubling participation. This should happen relatively quickly (months not years) as Patient Portal deployment will have early credibility/uptake with patients, and patient education resources can be utilized from existing sources (e.g., AccrualNet).
One can anticipate that the improvement in accrual rates should actually get more significant over time. Patients will be much more accustomed to the secure online environment with experience, and will be well versed in using it as a trusted source of information, as well as a tool to communicate with providers to address remaining concerns. Providers will also find new use cases for the tool that will help reduce some non-patient barriers and lead to strengthening participation rates (e.g., ability to search and find patients relevant for studies, the use of the technology to gain early feedback from patients on trial design to adjust and adapt).
Many of the legal/regulatory hurdles are addressed by vendor compliance with health privacy requirements. Institutional protocols will need to be developed and be subjected to IRB review, but no significant hurdles should be anticipated.
Patient Portals have been previously developed and deployed (in a variety of different practice contexts), with good success and acceptance. However, given that this is relatively new technology the use case for Portals in oncology research has not be systematically attempted (to my knowledge).
