Patient recruitment and retention are critical aspects of conducting successful clinical trials. Insufficient enrollment and high dropout rates can lead to delays, increased costs, and compromised study outcomes.

1. Welcome
PATIENT RECRUITMENT & RETENTION IN
CLINICAL TRIAL
Nahid
Pharm.D
063/042023
10/18/2022
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2. Contents
 Introduction
 Subject Recruitment
 Eligibility Criteria
 Informed Consent
 Methods of Patient Recruitment
 Steps involved in Patient Recruitment
 Patient recruitment Strategy and Challenges
 Patient Retention in Clinical Trial
 Methods to Retain subjects in Clinical Trial
 Recent Advances
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3. Introduction
Definition Subject recruitment in clinical trials refers to the process of identifying, screening, and enrolling eligible participants to
participate in a clinical research study.
Subject retention in a clinical trial refers to the strategy designed to keep participants enrolled in clinical trials, from
discontinuing participants from dropping out of the clinical trial
Goal The goal of subject Recruitment is to identify a study Population that meets the eligibility criteria for the Clinical Trial
and is willing and able to Participate in the study effectively
The goal of subject Retention is for participants to remain in the study for its duration, to provide valuable data and study objective
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4. Subject Recruitment in Clinical Trial
Recruiting the planned sample size within the defined time frame in clinical trials has proven to be the chief bottleneck in the drug development
process.
Recruitment in a clinical trial includes the following steps:
 Identifying or sourcing potential participants who may be eligible
 Discussing all aspects of the trial with them, ensuring comprehension and voluntariness, and subsequently obtaining informed consent for
participation
 Conducting a physical examination and screening procedures as mentioned in the protocol
 Enrolling the participant based on the eligibility criteria.
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5. Eligibility criteria
Eligibility criteria play a crucial role in subject recruitment in clinical trials. Eligibility criteria are used to identify and select participants who are
suitable for the study and are critical for ensuring that the study procedures are reliable and meaning full results.
Here are some reasons why eligibility criteria are important for subject recruitment
 Ensures Participant Safety
 Improves the validity of study results
 Reduces the risk of Adverse Events
 Ensures a representative study population
 Supports ethical consideration
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6. Types of Eligibility Criteria
1. Inclusion criteria
2. Exclusion criteria
3. Stratification Criteria
4. Screening Criteria
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Inclusion criteria are use to identify the participants who are suitable for the study based on
certain characteristic or condition .
Exclusion criteria are used to identify the participants who are not suitable for the study based on
certain characteristic or condition
Stratification criteria are used to group participants based on certain characteristic or condition
Screening criteria are used to identify potential participants who meet the initial eligibility
recruitments

7. Informed Consent
Definition -
Importance of Informed Consent in Subject Recruitment
 Protects the right & welfare of Participants
Builds trust between participants and researchers
Ensures compliance with the ethical and legal standards
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Informed consent is a process by which a person voluntarily agrees to participate in a clinical trial after being provided with all
the relevant information about the study. The process involve providing potential participants with information about the
study's purpose, procedure, potential risk and benefit and their rights as participants

8. Steps Involved in Informed Consent Form
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Step1- Introduction
Step 2- Explanation
Step 3 -Comprehension
Step 4 –Q&A
Step 5 - Consent

9. Methods of Patient recruitment
 Recruitment Strategy
 Budget
 Investigators Database
 Advertisements
 Web based
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10. Steps Involved in Patient recruitment
These are the following steps Involved in Patient Recruitment
 i
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1. Identification of Patient - As per the study protocol
Investigator Databases
Prescreening
2. Approach- Risk & Benefit assessment
Informed Consent Form
3. Informed Consent Form – Signed by patient
Undergo for screening
4. Assessment- Lab Report
Suitability
5. Enrollment- Inclusion/ exclusion criteria
Randomization

11. Recruitment Funnel
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12. Patient recruitment strategy
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13. Challenges
Challenges faced by the participants in a clinical trial
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Intricacy of study protocol
Sociocultural issues
Negative publicity by media
Inconvenient study schedules
Geographical distance
Concerns about getting a placebo
Concern about benefits of investigational product
Discouragement by treating physician
Lack of awareness about clinical trials
Fear of adverse events

14. Motivation for Participants
Motivation for participation to participate in clinical trial
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Therapeutic option
Access to health care
Individual medical care
Financial compensation

15. Retention in Clinical trial
Retention in a clinical trial is defined as the strategy and tactics designed to keep participants enrolled in clinical trials, from discontinuing
participation and dropping out.
A successful participant retention strategy involves:
 Treating the participant with respect
 Being considerate of the participant's time
 Identifying and overcoming barriers to retention in a timely manner
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16. Reason for Subjects Dropout
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 Relocation to another place
 History of adverse events on participation
 Fear of study-related procedures
 Length of the study
 Lack of Transportation
 Other Medical related problem
 Problems with participants’ employers regarding time off to attend study visits

17. Methods to Retain Subjects
 Communication – Explain up front that all data is important
 Protocol is followed throughout the study
 Ensure that the Right & Safety is the primary responsibilities
 Bonus at key time points
 Avoid large gaps between the study contact
 Cost of Transportation
 Encourage the patient to stay in the study even if they stop the treatment
 Offer convenient appointment time
 Financial Compensation
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18. Recent Advances
• Professional Recruitment Provider - Professional recruitment providers often work with Sponsor, CROs & SMO to improve recruitment
• Centralized recruiting - It is the centralized location for all information regarding potential participants, most suitable candidates are
selected at various research sites
• Informatics- Approach to find a good potential subject, the data obtained from pharmacies, physicians or hospital
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19. References
 Chaudhari N, Ravi R, Gogtay NJ, Thatte UM. Recruitment and retention of the participants in clinical trials: Challenges and solutions.
Perspect Clin Res. 2020 Apr-Jun;11(2):64-69
 https://www.makrocare.com/Whitepaper/patient-recruitment-retention-in-clinical-trials
 https://www.slideshare.net/swati2084/patient-recruitment-26469057
 Kadam RA, Borde SU, Madas SA, Salvi SS, Limaye SS. Challenges in recruitment and retention of clinical trial subjects. Perspect Clin
Res. 2016 Jul-Sep;7(3):137-43.
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20. Thank You!
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