Our CEO and founder, Kate Shaw, spoke with Leanne Woehlke, Director of Life Sciences Solutions at TransPerfect, and Will Krugman, Director of Marketing and Communications for Clinical Research Associates, about the importance of personalization, education and trust in boosting clinical trial patient recruitment and retention.
In the biopharmaceutical industry, clinical trial patient recruitment and retention is a pivotal part of the drug development process. Participants are a study’s lifeblood and can impact the future of the clinical trial and the potential treatment itself.
Poor clinical trial patient recruitment risks studies becoming underpowered and less able to make robust treatment recommendations for the patient population in question. It is also most commonly cited as the cause of premature discontinuation of randomized controlled trials (RCTs).
Without effective strategies in place to recruit enough patients into a trial and keep them engaged throughout, potentially life-changing treatments may never make it to market. This is disastrous for patients and also wastes valuable time and resources for sponsors and sites.
“We know even if we look at industry metrics, it’s $6,000, on average, to recruit a patient for a study and $19,000 to replace that patient if they are lost to follow up. So you’re when you’re able to keep those patients, you’re saving…an exponential amount of money.” – Leanne Woehlke
Why you need a bespoke clinical trial patient recruitment strategy
Not only is it vital to enroll enough patients into a study to make it viable, it is also important to involve a diverse range of participants to ensure results are robust and enable accurate treatment recommendations for different groups of eligible people.
Kate and Will both agreed that bespoke recruitment plans are crucial for successful clinical trial patient recruitment. While these should ideally be personalized for each research site, there should be some common factors.
> Building relationships and trust
Trust is fundamental to clinical trial patient recruitment and retention success, but this is not always easy to achieve. Some of this may be attributed to a lack of understanding but events, such as the 1932 Tuskegee study, experiments by Nazi doctors during World War II and delayed efforts to eradicate polio in India and the Democratic Republic of Congo, have also affected trust in clinical research.
There is no ‘quick fix’ to building trust; prolonged and consistent community outreach is the key, especially when seeking to increase patient diversity in clinical trials. It can be a time- and resource-intensive task, but one that will pay dividends in the future.
“We need to…have much longer engagement with people from different communities, so it’s not just a one-and-done; we’re there, we’re there for the long term, they get to know us, they get to understand us and ultimately they get to trust us.” – Kate Shaw
Here at Innovative Trials, our Clinical Enrollment Managers can work with sponsors and sites to develop community engagement strategies as part of the clinical trial patient recruitment process. Read how our community outreach accelerated patient recruitment for a Phase IIa study for moderate to severe hidradenitis suppurativa (HS) and increased the diversity of participants in a separate Phase III active systemic lupus erythematosus (SLE) trial.
> Having a consumer mindset
A key component of relationship building, particularly during a clinical trial’s patient retention phase, is to focus on understanding who your study participants are and catering to their needs. Will Krugman refers to this as a ‘consumer mindset’.
For Will, this is exceptionally important because people can drop out of a study at any time, for any reason. By focusing on patients, engaging with them regularly, helping them to mitigate potential participation barriers, and showing that you appreciate their involvement, people will feel valued and be more likely to remain in the trial.
“Really get to know your individual patients and see what makes them tick and work with them individually…Everybody is different, every site is different, but I think that the relationships and trust and service are the important things there.” – Will Krugman
Retention is all about relationships and this ethos lies at the center of Navigator. Our patient-focused service treats every participant like a VIP from the pre-screening stage through to study endpoint, minimizing the risk of patients dropping out of a trial.
Navigator, which launched last year, is already highly rated amongst sponsors and sites for accelerating clinical trial patient recruitment, increasing retention and removing the burden of patient engagement from sites, which allows them more time to focus on the science and other aspects of patient care. Read more about how Navigator can boost your clinical trials patient recruitment and retention.
> Education
A study in 2020 highlighted that many people at that time knew relatively little about the process of clinical trials. This lack of knowledge, which was found to be more prevalent among Hispanic and non-Hispanic Black adults in the US, is not just a barrier to clinical trial patient recruitment, but a barrier to diverse clinical trial patient recruitment. For studies to be at their most robust and impactful, participants must represent all facets of the patient population.
The solution to this problem is education. Making sure that the public understands what clinical research is, why trials are necessary, the benefits and risks of taking part, and how participation in a study can help shape treatment pathways globally.
For Kate, this must be done early on to ensure people can give informed consent. It should also be open and honest to keep building trust between patients and research staff. She says it can also help people to realize they are part of a ‘clinical trials community’ and one of a set number of people taking part in the same trial to advance treatments and vaccines for the good of mankind.
“Part of the whole recruitment process…[is] ensuring that patients understand exactly what they’ll be doing in the trial and exactly what they won’t be doing. Exactly what they’ll be getting, exactly what they won’t be getting so that we’re all basically agreeing to what’s going to happen and making that informed decision.” – Kate Shaw
> Clear information
If we want to recruit clinical trial patients and keep them engaged throughout the lifespan of a study, information must be presented in a simple and clear way, and in a format and language that is most appropriate for that specific patient population.
“…a lot of the times, the patient-facing communication is written by a medical professional, who is highly trained, who has very specialised knowledge, and that’s very important, but you need somebody as well to, kind of, translate that into normal person language.” – Will Krugman
If people are not clear about what is being asked of them, they will be far less likely to participate or may enroll but quickly become unhappy and drop out. When information is presented clearly, misunderstandings can be prevented and all parties know what is expected of them.
| Increasing clinical trial patient retention through education and information Innovative Trials was recently engaged in supporting a breast cancer trial with its patient retention. Most participants were experiencing positive results in the study, but this meant that many people were not attending their site visits as they did not feel a need to. While it is, of course, fantastic that participants felt able to get on with their lives, the lack of engagement threatened to terminate the study. To tackle this and ensure the longevity of the trial, our team focused on educating the study’s patients on why it’s so important to keep their site visits. We wanted everyone taking part to understand that being part of the clinical trial and seeing it through to the end could not only benefit themselves, but also the millions of other people living with breast cancer worldwide. Through clear messages and information, we reinvigorated the study’s participants to return for their visits, thereby preventing early termination. |
Improving clinical trial patient recruitment and retention rates needs tailored, site-specific approaches, which include:
- a patient-centric ‘consumer’ mindset to ensure participants feel heard, respected and valued,
- clear information to educate potential participants and set expectations
- long-term dedicated efforts to build trust.
For sites, especially those that may have a small team or lots of competing priorities, Kate says even spending just 10 minutes a day focusing on an element of recruitment can generate results.
“…do what you can, whether that means that’s making a few phone calls to referral doctors or actually standing in a clinic…potentially seeing patients that way or looking at their charts, whatever that is. Definitely, even 10 minutes a day can make a huge difference, so that’s what I’d like to recommend to everybody.” – Kate Shaw
Our tailored and flexible solutions can accelerate your clinical trial enrollment and secure ongoing engagement from participants for more robust results. Contact us today to find out more!
References
- McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006 Apr 7;7:9. doi: 10.1186/1745-6215-7-9. PMID: 16603070; PMCID: PMC1475627.
- Briel M, Elger BS, McLennan S, Schandelmaier S, von Elm E, Satalkar P. Exploring reasons for recruitment failure in clinical trials: a qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada. Trials. 2021 Nov 25;22(1):844. doi: 10.1186/s13063-021-05818-0. PMID: 34823582; PMCID: PMC8613940
- M. Briel, K.K. Olu, E. von Elm, B. Kasenda, R. Alturki, A. Agarwal, N. Bhatnagar, S. Schandelmaier A systematic review of discontinued trials suggested that most reasons for recruitment failure were preventable J. Clin. Epidemiol., 80 (2016 Dec), pp. 8-15. doi: 10.1016/j.jclinepi.2016.07.016. Epub 2016 Aug 3. PMID: 27498376
- Chatio ST, Ganle JK, Adongo PB, Beisel U (2023) Factors affecting trust in clinical trials conduct: Views of stakeholders from a qualitative study in Ghana. PLOS Glob Public Health 3(3): e0001178. https://doi.org/10.1371/journal.pgph.0001178
- Patel, E. U., Zhu, X., Quinn, T. C., & Tobian, A. A. (2022). Public knowledge and attitudes toward clinical trials in the COVID-19 era. American Journal of Preventive Medicine (Print), 62(3), 469–471. https://doi.org/10.1016/j.amepre.2021.09.002
Yadav S, Todd A, Patel K, Tabriz AA, Nguyen O, Turner K, Hong YR. Public knowledge and information sources for clinical trials among adults in the USA: evidence from a Health Information National Trends Survey in 2020. Clin Med (Lond). 2022 Sep;22(5):416-422. doi: 10.7861/clinmed.2022-0107. Epub 2022 Aug 10. PMID: 36507814; PMCID: PMC9595001