86% of international clinical trials do not meet their patient recruitment target within the relevant timeframe, and 8 out of 10 studies struggle to recruit enough patients1. Establishing a cohort of people suffering from the target pathology can therefore be difficult. This challenge results in the lengthening of the time required for conducting the trial and may delay the arrival of new drugs. At Servier, we are convinced of the importance of innovation to facilitate and accelerate patient recruitment and ultimately provide them with new therapeutic solutions more quickly.
Recruitment of patients for clinical trials: a key link in the development of innovative treatments
Patient recruitment has a strategic role in the success of clinical trials. It can have a direct impact on their scientific reach. The representativity of cohorts is also a major ethical issue.
Longer development time of new drugs
The duration of the recruitment process for clinical studies determines the time required for marketing the therapeutic innovations studied.
In fact, the shorter the recruitment period, the faster the candidate drugs can be developed and evaluated and then approved and marketed. Conversely, a delay in recruitment will have an impact on the development of the drug, and on making it available to patients and health professionals.
Recruitment difficulties in figures:
Recruitment difficulties are one of the main causes of delays in clinical trials.2
18 %
of clinical trials fail to recruit a sufficient number of patients.3
60%
Among more than 10,000 recruiting oncologic clinical trials worldwide, 60% manage to enroll less than 5 participants at each site, and more than 20% enroll none.4
4%
In the United States, less than 4% of adults participate in a clinical trial. This rate has not increased since 1994, in spite of increasingly longer recruitment periods.5
Scientific and ethical recruitment challenges
Inappropriate patient recruitment can affect the external validity of the study results. In other words, it can weaken the possibility of generalizing its conclusions to a larger population, beyond the patient sample studied.6
In order for the results of a clinical trial to be considered reliable, the patient cohorts must accurately reflect the target population affected by the pathology. They combine patients with varied profiles in terms of age, sex, socio-professional categories, living environment, health condition, etc. For medical research, the right balance between the methodological rigor required for the validity and the generalization of study conclusions and the operational pragmatism that aims at speeding up patient recruitment must be found.
The need for representative cohorts is not just scientific, it is also ethical. This representativity thus guarantees that medical progress benefits all patients, without exclusion or bias. An essential commitment in the eyes of Servier. Furthermore, for many diseases such as cancer and rare diseases, a clinical study may represent the only hope available for the patients. In specialty care, clinical studies are increasingly an integral part of the health care process. It is therefore a question of promoting equal access to clinical studies.”
Nicolas Garnier, Chief Patient Officer at Servier
Addressing the recruitment challenge in the age of precision medicine
Precision medicine is based on the administration of targeted therapeutic solutions adjusted to the biological specificities of each patient. Its emergence leads to the creation of groups of people who share the same biological characteristics. In that context, precision treatments target more restricted and more homogeneous patient categories7. This fine segmentation makes patient recruitment for clinical trials more complex. In fact, it involves identifying individuals who sometimes have a biological fingerprint which is not common in the general population. This makes deploying innovative strategies for clinical trial recruitment even more crucial.
Methodological, logistical, socio-economic and psychological obstacles to recruitment
The pharmaceutical industry encounters several obstacles when trying to recruit patients for clinical trials.
The eligibility criteria are often very strict
Even though essential to guarantee the validity of the trial, these criteria can sometimes significantly reduce the number of eligible patients8. Their identification can then be particularly time-consuming and result in a relatively long recruitment time.
Logistical, financial and time constraints
The capacity of investigator research centers to recruit volunteers for clinical trials is also limited by their geographical location9. These centers are often located in large cities or in the immediate vicinity of hospital centers. Patients who live far from these institutions are faced with financial, logistical and time constraints. These constraints can discourage them from participating in the trial despite the therapeutic benefits they may draw from it. In the case of rare diseases, the impact of this geographical impact can be particularly significant in view of the small number of patients affected.
In the United States, 70 % of patients and patients eligible for a clinical trial live more than 2 hours away from an investigation center.9
Patients lack information concerning clinical trials
A large number of patients are not aware that they can participate in a clinical study. Others are reluctant to participate for multiple reasons. Among them, unawareness of potential therapeutic benefits or the fear of the side effects of the treatment or of being assigned a placebo10, an increasingly rare situation thanks to the greater use of synthetic arms. Some patients also fear the administrative complexity inherent to the clinical trial participation process.
Socio-economic inequalities that hinder participation
Some populations remain structurally remote from clinical trials due to socio-economic determinants. The lack of financial resources makes participation more difficult for disadvantaged people, due to the indirect costs it involves (travel, loss of revenue, childcare, etc.). Secondly, a low level of education or the lack of health literacy, i.e. the ability to understand and use medical information, can hinder the understanding of the issues of the trial, thus fostering a reluctance to participate. There is also a growing distrust of the health system and medical research, often fueled by a feeling of exclusion or history of discrimination experienced.
Clinical trials: a unique opportunity for patients to benefit from cutting-edge therapeutic solutions.
For the volunteers, participating in a clinical trial represents a unique opportunity to benefit from a new drug and to contribute to scientific progress. A particularly hopeful perspective, especially for those patients with a limited number of therapeutic solutions, such as persons suffering from rare genetic diseases.
An essential modernization of recruitment for clinical trials
The pharmaceutical industry currently has several levers at its disposal to build effective patient recruitment strategies for clinical trials.
Decentralizing clinical trials for a more inclusive recruitment
Objective: bringing the study closer to the patients via centers authorized to conduct the clinical research on behalf of the principal center. For example, the activation of recruitment centers networks in Australia allowed recruiting cancer patients with a specific genetic deletion who lived far from the principal investigation center.
It is also possible to include digital solutions such as electronic consent, remote quality of life assessments and equipping patients with medical devices. This allows accelerating the deployment of these decentralized clinical trials, while making the transfer of study data easier.
Of course, the use of digital technologies must be accompanied of reinforced monitoring of patient data protection and obtaining their consent. The protection of their personal information and the confidentiality of their follow-up must be guaranteed.
30 to 50%
The Covid-19 pandemic considerably accelerated the development of hybrid clinical trials. Before the pandemic, only 5 to 15% of clinical trials were decentralized, compared to 30 to 50% today11.
Digital strategy, a key lever to accelerate the recruitment of patients for clinical trials
The implementation of digital recruitment strategies using social networks and on-line platforms also allows improving clinical trial recruitment12. These digital solutions offer advanced decentralized recruitment and targeting possibilities. They are a major asset to build representative cohorts, because they guide the patient search as a function of very precise criteria (location, age, centers of interest, etc.).
Furthermore, the emergence of the use of artificial intelligence already allows in certain countries, such as the United States, to automatically review patient records in detail within the research centers, in order to identify potentially eligible patients faster.
Servier x Klineo : Facilitating access to clinical trials thanks to a digital platform
In 2024, we formed a partnership with Klineo, around our common ambition: improving the access of all patients to clinical trials and allowing them to benefit from innovative therapeutic solutions. Thanks to the digital platform developed by this start-up, patients and doctors can identify the most suitable clinical trials in a few clicks. They can also receive therapeutic opportunities corresponding to their pathology in real time. A powerful digital innovation that considerably reduces inequalities in access to the treatments of tomorrow.
The key role of the medical community
Health professionals and patient organizations are also an integral part of any recruitment strategy for a clinical trial. In direct contact with patients, they are a vital link to raise awareness about participation in clinical trials and to help them evaluate the risk-benefit balance.They also play a key role in “demystifying” therapeutic innovation and participation in a clinical study.
For example, in the United States, studies show that the main obstacle to the recruitment of representative cohorts is the lack of information13. When the possibility of participating in a study is presented to patients from different communities, they accept in the same proportions. This means that the fight for equity in the access to clinical trials starts with the fight for equity in the access to information on these studies.
“Today, patient recruitment for clinical trials takes place primarily via the medical personnel of the investigation center14. This approach, even though essential, presents certain limits. The pharmaceutical industry must explore new recruitment procedures. Specifically, it can take advantage of social networks and continue to strengthen its relationship with patient organizations. It is also essential to raise awareness among patients about the unique opportunity that clinical trials represent: benefiting from innovative therapeutic solutions while helping research advance.”
Marta Garcia Manrique, R&D Chief Patient Officer at Servier
[1] Grant D. Huang et al. (2018). Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative – https://pubmed.ncbi.nlm.nih.gov/29330082/
[2]Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Nov 4;22(11):e22179. doi: 10.2196/22179. PMID: 33146627; PMCID: PMC7673977- https://pmc.ncbi.nlm.nih.gov/articles/PMC10565197/ – page consulted on 10 April 2025
[3] A fifth of cancer therapy trials fail to enlist enough participants – Medical News Today – https://www.medicalnewstoday.com/articles/304607- article consulted on 30 April 2025
[4] Oncologic patients’ misconceptions may impede enrollment into clinical trials: a cross-sectional study – PMC – https://pmc.ncbi.nlm.nih.gov/articles/PMC8742439/- article consulted on 16 May 2025
[5] Idnay B, Fang Y, Butler A, Moran J, Li Z, Lee J, Ta C, Liu C, Yuan C, Chen H, Stanley E, Hripcsak G, Larson E, Marder K, Chung W, Ruotolo B, Weng C. Uncovering key clinical trial features influencing recruitment. J Clin Transl Sci. 2023 Sep 4;7(1):e199. doi: 10.1017/cts.2023.623. PMID: 37830010; PMCID: PMC10565197 – https://pmc.ncbi.nlm.nih.gov/articles/PMC10565197/ – page consulted on 16 April 2025
[6] Comment le praticien doit-il interpréter les résultats d’un essai clinique ? – J.-M. Azorin a, M. Adida a, O. Blin b, N. Simon c, E. Fakra d, M. Cermolacce a, T. Bottai e, D. Pringuey f, J.-A. Micoulaud-Franchi g, R. Belzeaux a, A. Kaladjian – https://www.sciencedirect.com/science/article/abs/pii/S0013700617300507#:~:text=La%20validit%C3%A9%20externe%20renvoie%20aux,aliment%C3%A9e%20par%20la%20validit%C3%A9%20externe – page consulted on 25 April 2025
[7] LEEM – Essais cliniques 2030 – https://www.leem.org/sites/default/files/2022-03/Etude%20essais%202030_synthese_Leem.pdf – document consulted on 25 April 2025
[8] Le nombre médian de participants dans les essais cliniques sur les maladies rares s’élève à 29, contre 62 pour les maladies plus courantes, à l’échelle des Etats-Unis, du Canada et de l’Union européenne. Les essais cliniques sur les maladies rares sont alors plus susceptibles d’être à bras unique, non randomisés et ouverts. Source : Bell SA, Tudur Smith C. A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov. Orphanet J Rare Dis. 2014 Nov 26;9:170. doi: 10.1186/s13023-014-0170-0. PMID: 25427578; PMCID: PMC4255432. – https://pubmed.ncbi.nlm.nih.gov/25427578/
[9] National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation; Shore C, Khandekar E, Alper J, editors. Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2019 Jul 23. 2, Opportunities to Improve Clinical Trials. – https://www.ncbi.nlm.nih.gov/books/NBK548971/ – page consulted on 28 April 2025
[10] Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review. Contemp Clin Trials Commun. 2018 Aug 7;11:156-164. doi: 10.1016/j.conctc.2018.08.001. PMID: 30112460; PMCID: PMC6092479. – https://pmc.ncbi.nlm.nih.gov/articles/PMC6092479/ – page consulted on 23 April 2025
[11] LEEM – Essais cliniques 2030 – https://www.leem.org/sites/default/files/2022-03/Etude%20essais%202030_synthese_Leem.pdf – LEEM – Clinical trials 2030 – document consulted on 25 April 2025
[12] Accelerating patient recruitment using social media: Early adopter experience from a good clinical practice-monitored randomized controlled phase I/IIa clinical trial on actinic keratosis – PubMed – https://pubmed.ncbi.nlm.nih.gov/38234709/ – document consulted on 16 May 2025
[13] Racial diversity in clinical trials: Barriers and opportunities | Stanford Cancer Institute – https://med.stanford.edu/cancer/about/news/diversity-trials – page consulted on 16 May 2025
[14] Les méthodes de recrutement les plus fréquemment rapportées sont le contact en face à face (92,9 %) et la publicité en ligne via des sites web (53,9 %) – Idnay B, Fang Y, Butler A, Moran J, Li Z, Lee J, Ta C, Liu C, Yuan C, Chen H, Stanley E, Hripcsak G, Larson E, Marder K, Chung W, Ruotolo B, Weng C. Uncovering key clinical trial features influencing recruitment. J Clin Transl Sci. 2023 Sep 4;7(1):e199. doi: 10.1017/cts.2023.623. PMID: 37830010; PMCID: PMC10565197 – https://pmc.ncbi.nlm.nih.gov/articles/PMC10565197/ – page consulted on 16 April 2025