At Innovative Trials, we have contributed our clinical trial patient recruitment and retention expertise to more than 400 clinical trials and played a part in bringing over 15 new treatments to market. Of the 30 therapeutic areas our work has covered so far, oncology is a key area. Between 2018 and 2023, we supported 108 clinical trials focusing on oncology, ensuring they all achieved timely enrollment. One such study, which is currently still ongoing, is a Phase III clinical trial for patients with either stage IIIB or IV unresectable melanoma. The study involves 118 research sites across 25 countries.
For this particular study, the sponsor had never run an oncology study before, so we were commissioned to provide in-country support to help sites overcome recruitment challenges. As the only clinical trial patient recruitment and retention company with in-country support in 70-plus countries, we are ideally placed to partner with sponsors on global studies like this.
Over a period of 24 months, sites that received our support vastly outperformed those that did not receive or opted out from our service. Results include:
By accelerating clinical trial patient recruitment, we unlock faster access to a potential treatment for patients, saving the sponsor time and money.
Melanoma incidence
Melanoma is estimated to be the 17th most common cancer globally. It is a type of skin cancer that develops from cells called melanocytes. These cells are responsible for producing melanin, the pigment that determines the color of your skin.
In 2022, about 331,722 people worldwide were diagnosed with melanoma, and roughly 58,667 people with the condition sadly died. It is considered an aggressive cancer because it is more likely to spread to other parts of the body than other types of skin cancer, so early diagnosis and treatment is important. The Global Cancer Observatory predicts the number of new cases of melanoma per year will increase by 66% by 2045, to around 552,0003. The study we supported is focused on a potential treatment for people diagnosed with stage IIIB or IV melanoma for whom surgery is not an option.
Study challenges
This Phase III melanoma clinical trial presented several challenges for successful and timely patient recruitment, such as:
- low prevalence of disease type
- rapid disease progression
- a 24-month treatment phase, which potentially means a significant ongoing commitment by patients who are typically very unwell
- physicians in countries with access to a similar (licensed) treatment, so would be less likely to see the benefit of referring their patients into the study
- a simultaneous crossover study investigating the same compound, which could result in study fatigue
- multiple contacts, such as the sponsor, medical monitors and Clinical Research Associates (CRAs) actively speaking to sites about recruitment, risking site fatigue
- many sites feeling demotivated, especially as a similar licensed treatment is already available in most countries involved in this study, making recruitment more difficult.
In-country support strategies
Due to the very specific nature of the enrollment criteria, and following feedback from research sites, it was clear that traditional media and digital campaigns would not be appropriate. We knew that building relationships through human connection would be the key to reaching and recruiting participants for this particular clinical trial.
With this in mind, we engaged our 1:1 in-country support to:
- provide a series of 1:1 coaching calls. This included appropriate scheduling to eliminate duplication of conversations with other contacts and minimize the risk of study fatigue in site staff
- review site-specific recruitment and retention plans and help develop them further
- support the optimization and expansion of sites’ patient pathways
- run a series of three workshops for research staff to encourage global connection, foster motivation, discuss strategies and share learnings, practical tips and best practices. Each workshop covered different topics:
- Optimal placement of recruitment materials, hosting informational meetings, and patient considerations
- Setting goals and managing key relationships, including patients, caregivers and physicians
- Recruitment updates and evaluating screen failure data, patient insights, and referral colleague resources.
Our in-country support was commissioned for 118 sites in 25 countries across Europe, the Middle East and Africa (EMEA), Asia-Pacific (APAC), North America (NA) and Latin America (LATAM). In each country, we utilized our network of local Clinical Enrollment Managers (CEMs) to oversee and manage all patient recruitment coaching and support activities. As the only clinical trial patient recruitment and retention company with in-country support in 70-plus countries, we can ensure localized support wherever your study is going ahead.
Our impact on clinical trial patient recruitment
Sites that received our in-country 1:1 support experienced greater clinical trial patient recruitment success than sites not supported by us. In LATAM, for example, Innovative Trials-supported sites brought in more than double the number of enrolled patients, on average, compared to sites that chose not to receive our support (3.6 vs. 1). Likewise, sites that were committed to our support benefited from stronger screening and randomization rates, on average. Interestingly, even sites that opted out of our support partway through reported greater success in screening and randomization rates compared with those that did not receive any support at all.
Thanks to our 1:1 in-country support, more patients have been able to enrol more quickly into this Phase III study, giving them faster access to a potential new treatment. For the sponsor, this means the clinical trial can proceed sooner than it would have done otherwise, saving time and money. Overall, sites reported feeling supported, connected to the broader study, and more motivated. This is due in no small part to our focus on human connection. The majority of staff found our three patient recruitment workshops useful, and told us our 1:1 in-country support helped them consider new strategies and ideas for clinical trial patient recruitment. Of the sites that rated our support, we achieved 4.3/5.
What people say about our in-country support
“This study was a great example of collaboration and flexibility by Innovative Trials…”
“The gathering and reviewing of metrics and interpreting their application has contributed to making educated decisions. The willingness to work through new solutions and collaborate on execution has been effective and appreciated. The ability to think outside of the box, to adjust approaches and to shift perspectives mid-flight has been immensely well received. The generating of new content and delivering workshops has been outstanding – we are always impressed.”
Need help to supercharge your clinical trial patient recruitment? Contact us now to utilise our 15 years of dedicated experience in accelerating patient enrollment for your clinical studies.
References:
- Companies House (2025, June 25). Companies register activities: statistical release April 2024 to March 2025. GOV.UK https://www.gov.uk/government/statistics/companies-register-activities-statistical-release-april-2024-to-march-2025
- Wang M, Gao X, Zhang L. Recent global patterns in skin cancer incidence, mortality, and prevalence. Chin Med J (Engl). 2025 Jan 20;138(2):185-192. doi: 10.1097/CM9.0000000000003416. Epub 2024 Dec 17. PMID: 39682020; PMCID: PMC11745855
- Global Cancer Observatory (n.d.). Cancer tomorrow. https://gco.iarc.who.int/tomorrow/en/dataviz/isotype?cancers=16&single_unit=50000