Obstacles include patient perceptions and information about clinical trials, lack of awareness about opportunities to take part in trials, concerns about placebos, travel time and trial related expenses (1).
Additional research indicates that sponsors, contract research organisations (CROs) and clinical study sites should proactively address these patient-related barriers before starting any new clinical trials (2). There are five core, practical steps that can be taken to help foster patient-focused participation.
1) Develop patient centred trial designs
By focusing on the long-term availability of patients at the start of the study, companies can potentially reduce their overall expenses and tap a wider range of suitable patients across multiple sites. The Medical Research Council UK therefore recommends that before a trial begins, CROs should liaise with local patient advocacy groups and organisations to seek their input on the design and encourage their sense of ‘ownership’ of the trial.
Barb Geiger, executive VP of clinical research organisation Clinipace, also noted that patients interested in participating in a trial should be identified before a site is established. “Individual, personalised and patient-centric medicine represents the future of clinical research, notably in oncology. We need to write protocols and plan recruitment strategies based upon individual patient needs and not on a disease class.” (2)
2) Build strong relationships with patient registries and trusted clinicians
Patient organisations have developed registries and research networks to contribute to clinical research, with the goal of driving improvements in engagement, care and health (3). In addition, a major analysis of recruitment barriers also suggests that more companies should use electronic medical records and hospital-based databases to identify potential patients (4). These databases can allow researchers to work with clinicians to rapidly pre-screen potential participants for clinical trials (1).
The research indicates that study managers and CROs should start building relationships with established patient organisations as soon as possible. They should also develop relationships with trusted physicians to create referral programs for patients who may be eligible for new clinical trials.
3) Streamline patient testing with point of care testing devices
The collection of excess data or inclusion of unnecessary trial procedures can lead to more frequent study visits and may prevent streamlining of study design. When writing the study protocol, companies should consider the potential impact of the choice of medical equipment on patient enrolment and retention.
For example, survey results show that patient advocacy groups were significantly more likely than sponsors, CROs and research sites to rate transportation to trial visits and out-of-pocket expenses as recruitment barriers (4).
By building in point of care testing (POCT) during the study design, companies may be able to help reduce the number of site visits, travel time and travel expenses for patients. Education about the benefits of POCT at the patient consent stage can help to encourage interest; improving recruitment and retention throughout the trial. An extra benefit is that POCT equipment can help companies reduce the costs, risks and time involved in transporting samples to laboratories for testing.
4) Address patient concerns
Misconceptions about clinical trials are among the most significant reasons patients miss opportunities to be treated within research settings. For example, a study of 6,000 US cancer patients found that 16% of respondents had declined to take part in a trial because they believed that the treatment would be less effective than ‘standard treatment’ (37%), they worried about being given a placebo (31%), or they feared ‘being treated as a guinea pig’ (22%) (5).
By making an effort to reach out to patients with accurate, accessible information, companies can help to dispel these fears. This means distributing information and education through networks and media channels that those patients are most likely to use, such as Facebook, LinkedIn and Twitter. Educational campaigns could focus on factors like the fact that clinical trials are generally safe, and new therapies may offer a better treatment option than traditional therapies.
In planning and managing the trial, study managers should also assure patients that they will be treated with respect and support at each stage of the study.
5) Reach e-patients and physicians through social media
Clinical trial sponsors and CROs have woken up to the power of social media in contacting ‘e-patients’. This term describes individuals who are “equipped, enabled, empowered and engaged in their health and health care decisions”6 Many e-patients see themselves as equal partners working with doctors to access the right healthcare support. Social media is now being used to maintain strong relationships with patient networks, and to increase patient recruitment and retention; as well as to disseminate information to physicians. Many CROs are also using webinars and trial-matching websites to reach both e-patients and physicians.
Although social media can help to quickly spread clinical study information to a wide network of people, e-patients will not necessarily respond to generic promotional posts. Instead, these posts should be engaging, informative and focused on their individual needs.
One size doesn't fit all
While there are several practical steps that companies can take to overcome patient recruitment barriers, one size does not fit all. Study managers should create an action plan at the start of each trial and ensure they partner with vendors that are best placed to help them achieve their specific goals for the study. The right combination of strategies will allow study managers to tailor their approach so it works for different patient groups and physicians, to increase patient enrolment and long-term retention.
References
- Engaging E-Patients in Clinical Trials through Social Media, Blue Chip Marketing, May 2011.
- Geiger B. Oncology, May 2013. https://www.clinipace.com/patient-centric-enrollment-boosts-participationoncology-clinical-trials/ Accessed May 2016.
- US National Library of Medicine. 2015. Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey. [ONLINE] Available at: https://www.ncbi.nlm. nih.gov/pmc/articles/PMC4605726/. [Accessed 1 November 2016].
- Sertkaya A, Birkenbach A, Berlind, A, et al. Examination of Clinical Trial Costs and Barriers for Drug Development https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development. Accessed 04/16.
- Finn, R. Surveys Identify Barriers to Participation in Clinical Trials. J Natl Cancer Inst (2000) 92 (19):1556-1558.
- http://e-patients.net/about-e-patientsnet. Accessed April 2016.