Tuesday 22 January 2013

Subject Recruitment and Retention: Barriers to Success in Clinical Trial

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: 
  1.  Subject-Related Barriers.
  2.  Investigator-Related Barriers.
  3.  Protocol-Related Barriers.
  4.  “Other” Barriers.

 Subject-Related Barriers :
  1. Appointment hours are not Flexible.
  2. Uncertainty towards the trial.
  3. Unrealistic Expectation from the trial.
  4. Disease Status.
  5. Age of the patient.
  6. Level of education.
  7. Socioeconomic circumstances.
Investigator-Related Barriers:
  1. Logistical Factors.
  2. Personal Factors.
Protocol-Related Barriers:
  1. Protocol designs with eligibility criteria that are so tight that potential study subjects do not be eligible for entry.
  2. 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
  1. Direct advertising should be encouraged.
  2. Subject should be give the relevant information during the informed consent process.
  3. Subjects rights should  be protected by ensuring the review of documents by IRB/IEC.
  4. Develop an understanding of the population being recruited.
  5. Provide the clear insight of the inclusion/exclusion criteria.
  6. Develop close working atmosphere.
As the clinical trial is increasing the patient recruitment and retention is also becoming challenging.
  1. Increased public alertness through campaigns would eliminate the recruitment and retention barriers created by geographic, socioeconomic, and cultural factors.
  2. 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.
  3. Community education and consultation.

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