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Table 1 Summary of challenges encountered and strategies to overcome them

From: Collecting and reporting adverse events in low-income settings—perspectives from vaccine trials in the Gambia

 

Challenges

Strategies

Health-seeking behavior

Self-medication

• Require participants to abstain from self-treatment during the trial

• Provide free, round-the-clock medical care to participants

Traditional healers

• Require participants to avoid using herbal products during the trial

• Provide free, round-the-clock medical care to participants

• Maintain a non-judgmental approach

Health systems

Healthcare provision

• Work with MRCG CSD to provide inpatient care for participants

Diagnostic limitations

• Offer laboratory and radiology services at MRCG CSD

• Conduct verbal autopsies as required

Lack of reliable background data

• Conduct epidemiological studies to understand background disease rates

• Establish Health and Demographic Surveillance Systems

Sociocultural considerations

Literacy rates

• Conduct home visits to collect information on adverse events

Highly mobile population

• Ensure potential participants have no imminent travel plans during the study

• Maintain regular contact throughout the study period

• Send field workers to collect adverse events from participants who travel

Social dynamics

• Organize community sensitization meetings

• Use community advisory boards

• Hold open days for engagement