Table 3.
Challenges | Solutions for recruitment | Solutions for retention |
---|---|---|
Trial design with stringent eligibility criteria and longer follow-ups | Sponsors and investigators Early sponsor-investigator-other stakeholders’ meetings to draft a pragmatic protocol to address anticipated recruitment issues while writing a protocol Piloting the study in few sites and learn from the experiences |
Sponsors and investigators Setting realistic targets (site recruitment targets, feedback, and competition among sites) Options other than complete withdrawal Patient and public involvement Use of prescreening logs |
Declining site performance due to insufficient resources | Sponsors Develop site resources (e.g., giving necessary equipment to ease clinical trial conduct) Dedicated sponsor help desk for queries Disbursing funds to the site in a timely manner Investigators Staff training about recruitment |
Sponsors Develop site resources Staff training about retention |
Poor patient contact | Investigators IEC-approved newsletters, newspaper advertisements, scientific/educational presentations, patient support events, and community engagement, WhatsApp group notifications or other social media Continuing contact with wait listed participants Recruitment reminders (e-mail/CTMS alerts) |
Sponsors and investigators Additional contacts (reminders, newsletters, feedback for patients, websites calendars, and alert cards) |
Patient inconvenience | Sponsors and investigators Flexible appointments |
|
Nonmotivated site staff or participants | Sponsors Incentives (gifts for sites, co-authorship for good recruiters, and monetary incentives) Recognizing site champions Newsletters encouraging good sites |
Sponsors Incentives (gifts for sites, co-authorship for good retention, and monetary incentives) |
Other factors | Investigators Relationships (face-to-face initiation visit, regular contact with recruitment staff, and ongoing relationships between trials) |
Investigators Relationships (support for patient between visits, handwriting envelopes, festival/birthday cards, and thanking participants) |
CTMS=Clinical Trial Management System, IEC = Institutional Ethics Committee