A key hurdle for clinical researchers is the ability to reach their recruitment target. Slower recruitment can lead to significant financial losses and delay in getting lifesaving interventions to patients. As a result, many studies fail to meet their recruitment targets. Continuous pressure on clinical study teams can lead to stressful and ineffective working environments.
Linical Patient Recruitment expert, Gillian Lakareber, has described the factors that can affect recruitment in her book "A Guide to Patient Recruitment & Retention in Clinical Research: The 6 Core Outcome Factors Which Affect Patient Recruitment" and in this article she shares recommendations for maximizing the recruitment process through proper management of each of these factors.
Core Outcome Factor 1: Researcher Characteristics
The researcher characteristics are pivotal in the decision-making process of whether the potential subject will decide to participate in a clinical trial. The relationship between the patient and the doctor is pivotal to this decision-making process, and good rapport with a potential subject can be achieved by the investigator clearly explaining the study and highlighting the benefits/risks involved in participating. Thus, those at the forefront of engaging with potential trial subjects should be well equipped with adequate knowledge about the study and have the appropriate skills to conduct study activities. It has been reported that researchers are more effective in their role if they adapt to the needs of trial subjects and build a relationship with potential participants. Adapting to participants’ needs may be as simple as offering flexibility in appointment times and structuring the recruitment schedule to accommodate the needs of the participants. Ultimately, the goal is to enhance the participant’s experience by adopting positive strategies and building a strong relationship from the start of the study.
|
Recommendations |
|
· Assign a dedicated study coordinator or research nurse to focus on study activities |
|
· Ensure the invitation to participate is initiated by the patient’s doctor or a qualified professional |
|
· Offer additional patient recruitment training to inexperienced study team members |
|
· Researchers should increase their flexibility during the patient enrollment period |
|
· Researchers should provide clear explanation of the benefits and risks of the trial |
|
· The study team should invest more time in patient identification from the start of the study |
|
· The study team should attend the SIV and investigator meeting to complete mandatory training |
Core Outcome Factor 2: Participant Characteristics
Participant characteristics are factors relating to the subject participating in a trial. Understanding why clinical trials can be attractive to patients (e.g., altruism, interest in medicine, regular medical care) will make it easier for the study team to communicate with patients about potential trials. Also, understanding why patients may decline to participate in clinical trials (e.g., fear and family influence) will help the study team address these issues with sensitivity. Reasons for declining participation are usually related to the frequency of visit, the location of the study site in relation to their home, and the inability to take time off to attend clinic appointments. Fear and uncertainty experienced by the community has been reinforced by past negative cases in clinical research which have been negatively presented in the media. To circumvent this perception, there needs to be more public awareness on the benefits of clinical trials.
|
Recommendations |
|
· CROs and Sponsors should develop strong partnerships with study sites |
|
· Foster a shared goal of recruitment and retention success |
|
· Study sites should empower patients to ask about clinical research activities |
|
· Establish clinics/support groups or social events to disseminate trial information |
|
· Include patients associations in protocol planning and design |
|
· Increase financial support e.g., travel reimbursement and meal payments for patients |
|
· Increase publicity of positive patient experiences in the media |
|
· Increase the use of interpreters and support for non-English speakers and provide translated patient recruitment materials |
|
· Leverage the active advocacy organizations and patient groups in each region via outreach and social media to raise awareness about the study and direct potential referrals to study sites |
|
· Provide ethically approved incentives like thank you cards, diaries, travel bags, and pens |
|
· Promote retention by engaging with patients through efficient communication and ensure they continue their study participation throughout their study journey |
|
· Use mobility apps which allow patients to access trial information such visit guides to encourage retention in the study |
Core Outcome Factor 3: Location
The geographical location of the target patient population can affect patient accrual in a study. The three main factors which are influenced by location are:
|
Recommendations |
|
· Collaborate with local services to overcome logistical issues for laboratory or Investigational product management |
|
· Familiarize with local regulations and ensure the study team members have local experience |
|
· Offer expense reimbursement for travel and provide transportation solutions to participants |
|
· Strategically place clinical study sites near patients to decrease participant burden |
|
· Understand the treatment options available in different regions |
|
· Train and equip patients with electronic devices which can be used at home, e.g., blood pressure machines, electronic diaries etc.
|
Core Outcome Factor 4: Technology
The role of technology, Internet and social media is becoming increasingly important to patient enrollment. These tools are being used in a variety of areas e.g., using data science to identify participants by data mining, using emails to provide study information, using electronic diaries to capture clinical trial data, and using data mapping to identify key locations which contain the target population. There is an increasing movement towards the use of technological aids and social media platforms to attract the right target population. The emergence of social platforms on the Internet has transformed the way patient recruitment and advertising is conducted as it makes it easier and quicker for clinical researchers to reach their target population. The availability of online services also enables potential participants to access prescreening websites and directly submit their contact information to recruiting study sites. Further technology solutions such as electronic consenting and on-line assessments as appropriate can replace the need for patients presence at the site and should be offered to minimize the efforts to have to travel to sites.
|
Recommendations |
|
· Advertisements in magazines, newspapers, online journals, and radio |
|
· Create online forums for patients to share experiences |
|
· Create shared research databases which contain the target population |
|
· Increase the use of online social media platforms like Facebook, Twitter and You Tube |
|
· Leverage new technologies to assist with data sharing and patient engagement |
|
· Use real-world data integration and data extraction techniques and to assess feasibility |
|
· Use short health awareness videos to highlight the benefits of clinical trials |
|
· Use online databases to assess eligibility e.g., pharmacy databases |
|
· Use online forums to identify potential participants |
|
· Use pre-screening websites during the study |
|
· Use data science and data mapping during feasibility assessments |
Core Outcome Factor 5: Nature of Research
The nature of research conducted is influenced by factors such as the clinical study protocol, therapeutic indication and their complexities. Factors like study protocols, therapeutic indications, and complexity influence patient recruitment. Thus, often study sites will struggle to enroll participants if the inclusion/exclusion criteria are too strict. The recruitment strategy adopted will depend on the complexity of the trial, the phase, inclusion/exclusion criteria, and the therapeutic area, just to mention a few. For example, it can be said that some observational studies may be generally easier to recruit for because there is no change in treatment, there is less risk, and low burden/commitment is expected from the participants. In comparison, blinded trial designs can be seen to be more complex because of the uncertainty surrounding the treatment allocation. Amending protocols can improve recruitment by addressing issues. Open trial designs may attract more participants than blinded trials, however, the use of open-trial designs and opt-out strategies are controversial and must be carefully evaluated as they could pose methodological or ethical challenges.
|
Recommendations |
|
· Consider the need for protocol amendment to increase acceptability |
|
· Implement study visit run-throughs in which potential participants are given a deeper understanding of study expectations |
|
· Include the right patient cohort from the start of the study |
|
· Make the inclusion/exclusion criteria more realistic and less restrictive |
|
· The development of the study design and protocol should be risk and data aware from inception |
|
· There should be a realistic recruitment schedule and decrease in the time commitment on patients |
Core Outcome Factor 6: Systems & Procedures
The systems and procedures define the processes implemented to make patient recruitment conducive at three levels i.e., study site, country level, and regional level. To increase patient recruitment, there needs to be a robust infrastructure within these three levels. It is important for the study team to understand the systems and procedures which can affect trial participation at local and regional levels. This understanding can then inform contingency planning and risk mitigation strategies earlier on in the study. As competition for resources increases, difficult studies may be disregarded in favor of their easier counterparts. There is a need to increase the level of collaboration between primary and secondary care providers, as collaboration accelerates clinical development and allows stakeholders to save time and costs.
|
Recommendations |
|
· Carry out an inquiry to ascertain the resources/tools required to help with patient recruitment |
|
· Ease the pressure on the study team by increasing resources and funding |
|
· Focus on building and maintaining a strong rapport between the study team and participants |
|
· Implement robust feasibility and study site selection process |
|
· Increase advocacy for patient engagement, be more transparent and socially responsible |
|
· Increase collaboration with primary care clinicians and secondary care. There is potential to receive referrals from primary care providers |
|
· Look for patient identification centers near hospitals |
|
· Implement “concierge” services where appropriate (“decentralize” procedures) |
|
· Pre-screen clinic notes to identify potentially eligible patients |
|
· Seek additional funding from government organizations to assist with conducting the study |
|
· Share trial results with patients |
|
· Start a patient recruitment team focusing on identifying patients |
|
· Provide incentives to teams with successful recruitment |
Author:
Gillian Lakareber DBA MSc BSc (hons)
Linical Project Director
"A Guide to Patient Recruitment & Retention in Clinical Research: The 6 Core Outcome Factors Which Affect Patient Recruitment" is available in paperback and as an eBook for purchase on Amazon and 100% of the proceeds will be donated to charity for the education of children in rural areas across Africa.
About the author:
Dr. Gillian Lakareber is a multi-award-winning clinical research professional with many years of experience in various roles within clinical research as a Clinical Research Associate, Patient Recruitment Specialist, Clinical Trial Manager and Project Manager. Dr. Lakareber has amalgamated her industry expertise in clinical research and theoretical knowledge from her Masters and Doctoral education to formulate a guide for the benefit of clinical researchers in this field. Dr. Lakareber is an ardent advocate in raising awareness of robust patient recruitment and retention strategies, with the aim of accelerating lifesaving interventions to patients.