The Success to the Clinical trial depends upon the subject Recruitment and Retention but at the same time, successful recruitment of participants for any clinical trial is a challenge.
The Barriers to Recruitment and Retention may be classified in four broad groups:
- Subject-Related Barriers.
- Investigator-Related Barriers.
- Protocol-Related Barriers.
- “Other” Barriers.
Subject-Related Barriers :
- Appointment hours are not Flexible.
- Uncertainty towards the trial.
- Unrealistic Expectation from the trial.
- Disease Status.
- Age of the patient.
- Level of education.
- Socioeconomic circumstances.
- Logistical Factors.
- Personal Factors.
- Protocol designs with eligibility criteria that are so tight that potential study subjects do not be eligible for entry.
- Protocols that is too difficult for investigators to follow due to overly Complex study designs.
Other Barriers :
Research studies that fail to meet recruitment goals provide minimal scientific return and may have a negative financial impact on the institution.
Low rates of recruitment and retention:-In order to increase the rate of recruitment and retention
- Direct advertising should be encouraged.
- Subject should be give the relevant information during the informed consent process.
- Subjects rights should be protected by ensuring the review of documents by IRB/IEC.
- Develop an understanding of the population being recruited.
- Provide the clear insight of the inclusion/exclusion criteria.
- Develop close working atmosphere.
As the clinical trial is increasing the patient recruitment and retention is also becoming challenging.
- Increased public alertness through campaigns would eliminate the recruitment and retention barriers created by geographic, socioeconomic, and cultural factors.
- Individuals must be extra alert when dealing with the majority of subjects, who are ignorant, poor, and have a deep respect for and perhaps a blind belief in the physicians treating them.
- Community education and consultation.