Subject recruitment is a crucial step in clinical trials as it directly impacts the quality, feasibility, and success of the study. The process involves identifying and enrolling eligible participants who meet the study's inclusion and exclusion criteria. Here are some key considerations for subject recruitment in clinical trials: Eligibility Criteria: The study's eligibility criteria must be clear and defined in advance to ensure that only eligible participants are enrolled. Inclusion and exclusion criteria may include age, gender, medical history, disease severity, and other factors that are relevant to the study. Recruitment Methods: There are several recruitment methods that can be used, such as advertising in medical journals, social media, and online forums, collaborating with patient advocacy groups, and working with primary care physicians or specialists who treat patients with the disease or condition under study. Informed Consent: Potential participants must be provided with all necessary information about the study, including the study's purpose, procedures, risks, and benefits, and be given the opportunity to ask questions before providing informed consent to participate. Diversity: The study should aim to enroll a diverse population to ensure that the study results are generalizable and applicable to different populations. This includes ensuring adequate representation of different ethnic and racial groups, genders, ages, and other relevant demographic factors. Patient Engagement: Engaging patients in the recruitment process can help build trust and increase participation rates. This includes involving patient representatives in study design and working with patient advocacy groups to promote the study and recruit participants. Recruitment Timeline: Recruitment timelines should be realistic and feasible based on the study's objectives and design. Delays in recruitment can significantly impact the study's timeline, cost, and overall feasibility. Patient Retention: Once enrolled, it is essential to maintain communication with participants to ensure that they remain engaged and continue to participate in the study until completion. This includes providing regular updates, addressing any concerns or questions, and providing support as needed.

1. Welcome
Subject Recruitment In Clinical Trials
Hiba Ahmed
M pharm
Student ID:047/0323
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2. Contents
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Recruitment strategies
Target population
Informed consent
Challenges
Conclusion
Introduction
Eligibility criteria

3. Introduction
Definition
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Subject recruitment in clinical trials refers to the process of identifying, screening,
and enrolling eligible participants to participate in a clinical research study.
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. Effective subject recruitment is essential for ensuring that a study has a
sufficient sample size and is representative of the target population. It is also
important for minimizing bias and ensuring the safety and well-being of study
participants.
Goal

4. challenges in clinical trails:
Importance of clinical trials:
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Subject recruitment is a critical
component of clinical trials, and its
importance cannot be overstated.
Here are some reasons why subject
recruitment is essential in clinical
trials:
• Ensures sufficient sample size
• Ensures representativeness of
study population
• Minimizes bias
• Facilitates safety monitoring
• Supports ethical considerations
Despite the importance of subject
recruitment in clinical trials, there are
several challenges that researchers may
encounter when trying to recruit
participants. Some of these challenges
include:
• Limited eligible population
• Competition with other studies
• Lack of awareness
• Logistics
• Participant fear or mistrust:
• Language barriers

5. Eligibility Criteria
Types Of Eligibility Criteria Used In Clinical Trials
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1.Inclusion criteria:
2.Exclusion criteria:
Inclusion criteria are used to identify participants who are suitable for
the study based on certain characteristics or conditions. Examples of
inclusion criteria include age, gender, disease severity, and medical
history. Inclusion criteria are used to ensure that the study population is
homogeneous and that participants are likely to benefit from the
intervention being studied.
Exclusion criteria are used to identify participants who are not suitable for
the study based on certain characteristics or conditions. Examples of
exclusion criteria include comorbidities, medication use, and pregnancy.
Exclusion criteria are used to minimize the risk of harm to participants and
ensure that the study produces reliable and meaningful results.

6. Cont…
In addition to inclusion and exclusion criteria, there may be other types of eligibility criteria used in
clinical trials, depending on the nature of the study. These may include:
3. Screening criteria:
4.Stratification criteria:
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Screening criteria are used to identify potential
participants who meet the initial eligibility
requirements. Screening criteria may be used to exclude
participants who are unlikely to meet the inclusion
criteria or who meet the exclusion criteria.
Stratification criteria are used to group participants
based on certain characteristics or conditions.
Stratification criteria may be used to ensure that the
study population is balanced and representative.

7. • 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 produces reliable and meaningful results. Here are some reasons why eligibility
criteria are important in 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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Importance of eligibility criteria in clinical trials

8. • Here are some recruitment strategies that are commonly used in clinical trials:
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Recruitment Strategies
Digital
Marketing
Social Media Patient
Database
Electronic
Health
Records
Mobile
Health
Application
Community
engagements
refferals
Digital advertising,
including search
engine marketing
(SEM) and display
ads, can be used to
target individuals
who are searching
for information
related to the
condition being
studied. These ads
can be displayed on
search engine
results pages, social
media platforms, or
other relevant
websites.
Social media
recruitment: Social
media platforms,
such as Facebook,
Twitter, and
LinkedIn, can be
used to promote
clinical trials to
potential
participants. Social
media ads can be
targeted based on
demographics,
interests, and
behaviors, making it
easier to reach
individuals who may
be interested in
participating in the
study.
Patient databases,
such as electronic
health records
(EHRs) and disease
registries, can be
used to identify
potential
participants who
meet the eligibility
criteria for the
study. Researchers
can search these
databases to identify
individuals who may
be eligible for the
study and reach out
to them directly.
Electronic health
records (EHRs) can
be used to identify
potential
participants who
meet the eligibility
criteria for the
study. Researchers
can search these
records to identify
individuals who may
be eligible for the
study and reach out
to them directly.
Mobile health
(mHealth)
applications, such as
smartphone apps
and wearable
devices, can be used
to collect data from
participants and
track their progress
throughout the
study. These
applications can also
be used to promote
the study to
potential
participants and
encourage them to
enroll.
Community
engagement can be
used to promote the
study and recruit
participants from local
communities. This may
involve working with
community
organizations,
healthcare providers,
and other stakeholders
to raise awareness of
the study and
encourage
participation.
Referral
networks can be
used to identify
potential
participants who
may be
interested in the
study. These
networks may
include
healthcare
providers,
patient advocacy
groups, and other
stakeholders who
can refer
potential
participants to
the study.

9. Target Population
• Identifying appropriate target population:
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Disease
prevalence
Inclusion and
exclusion
criteria
Geographic
location
Patient
awareness
and interest
Physician
referral
patterns
Cultural and
linguistic
barriers

10. Informed Consent:
Definition :
Importance Of Informed Consent In Subject Recruitment
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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
involves providing potential participants with information about the study's purpose,
procedures, potential risks and benefits, and their rights as participants. Informed consent
also involves giving participants the opportunity to ask questions and receive answers about
the study
Protects the rights and
welfare of participants
Ensures compliance with
ethical and legal standards
Ensures voluntary
participation
Builds trust between
participants and researchers

11. Step by step process for informed consent
 STEP-I :Introduction: The researcher should introduce themselves to the participant and
explain their role in the study. They should also explain the purpose of the study and the
reason why the participant has been invited to take part.
 STEP-II Information Provision: The researcher should provide the participant with detailed
information about the study. This should include the study's purpose, procedures, potential
risks and benefits, and any other information that the participant may need to make an
informed decision about whether or not to participate.
 STEP-III Opportunity To Ask Questions: The participant should be given the opportunity to
ask questions about the study. The researcher should answer these questions clearly and
honestly, and provide any additional information that the participant requires.
 STEP-IV Voluntary participation: The researcher should emphasize that participation in the
study is voluntary, and that the participant is free to withdraw from the study at any time.
They should also explain that there will be no negative consequences if the participant decides
not to participate.
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12.  STEP-V Consent Form: If the participant decides to participate in the study, they should be
asked to sign an informed consent form. This form should clearly outline the information that
has been provided to the participant, and should be written in language that is easily
understood by the participant.
 STEP-VI Copy Of Consent Form: The participant should be given a copy of the signed
informed consent form, which they can keep for their records.
 STEP-VII Follow-up: The researcher should follow up with the participant after the consent
process to ensure that they fully understand the study and to answer any additional questions
that may arise.
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13. Challenges Faced In Subject Recruitment
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Limited patient pool
Participant retention:
Recruitment costs:
Competition with other
studies
Geographical
limitations:
Finding eligible participants
for the study can be difficult
if there is a limited pool of
patients with the condition
being studied.
Participants may be
recruited for other studies,
making it difficult to recruit
participants for a specific
study.
If the study is
restricted to a specific
location or region, it
may be difficult to find
enough eligible
participants.
Recruitment can be
expensive, especially if
extensive advertising is
required.
Retaining participants
throughout the study can
be challenging, especially if
the study requires a
significant time
commitment or involves a
burdensome intervention.

14. Conclusion
 In conclusion, subject recruitment is a critical component of clinical trials. It is important to
identify the appropriate target population, develop eligibility criteria, and use effective
recruitment strategies to ensure that the study is adequately powered and that the results are
generalizable to the population of interest.
 Informed consent is also a critical component of subject recruitment, as it ensures that
participants are fully informed about the study and are making an informed decision about
their participation.
 While there are many challenges to subject recruitment, there are also many solutions
available to address these challenges.
 Effective subject recruitment is essential for the success of clinical trials and ultimately for
improving patient care and outcomes.
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15. References
• Nayan Chaudhari, Renju Ravi, Nithya J. Gogtay, and Urmila M. Thatte, Recruitment
and retention of the participants in clinical trials: Challenges and solutions
• Woo M. An AI boost for clinical trials. Nature. 2019;573:S100–2. [PubMed] [Google
Scholar]
• https://www.slideshare.net/swati2084/patient-recruitment-26469057
• Doshi MS, Kulkarni SP, Ghia CJ, Gogtay NJ, Thatte UM. Evaluation of factors that
motivate participants to consent for non-therapeutic trials in India. J Med
Ethics. 2013;39:391–6. [PubMed] [Google Scholar]
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16. Thank You!
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info@clinosol.com
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