Clinical Study Participant Recruitment Task
(Redirected from clinical trial research participant enrollment)
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A Clinical Study Participant Recruitment Task is a clinical study subtask that is a person recruitment task which produces candidate clinical study participants (of clinical study participants).
- Context:
- It can (typically) be supported by a Patient Recruitment System.
- It can (typically) be preceeded by a Patient Identification Task.
- It can (typically) be followed by a Patient Enrollment Task.
- It can be associated with a Clinical Trial Recruitment Status.
- It can account for for Projected Participant Retention.
- …
- Example(s):
- Counter-Example(s):
- See: Clinical Trial, Evaluative Patient Data, Decentralized Clinical Trial, Clinical Trial Management System (CTMS).
References
2020
- (Antidote, 2020) ⇒ https://www.antidote.me/blog/15-clinical-trial-patient-recruitment-companies
- QUOTE: ... Clinical trial patient recruitment companies use a range of methods, from digital advertising to community partnerships, to find the right patients for your trial. Depending on your trial’s needs, you may want to choose a company with a particular specialty in a therapeutic area or patient population. You may also be interested in finding a company that offers additional services, such as developing your prescreener or helping you identify the best site locations for your study.
When choosing a company, consider each company’s offerings as well as experience in your therapeutic area. We’ve included additional questions we recommend asking at the bottom of the below list, as well as a primer on how clinical research recruitment companies connect with patients, and how patient recruitment companies can help solve common challenges. ...
- QUOTE: ... Clinical trial patient recruitment companies use a range of methods, from digital advertising to community partnerships, to find the right patients for your trial. Depending on your trial’s needs, you may want to choose a company with a particular specialty in a therapeutic area or patient population. You may also be interested in finding a company that offers additional services, such as developing your prescreener or helping you identify the best site locations for your study.
2019
- FDA. (2019). GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING
- QUOTE: Enrollment: The process of registering or entering a patient into a clinical trial. Once a patient has been enrolled, the participant would then follow the clinical trial protocol. Clinical investigations are designed to enroll a set number of participants to increase the likelihood of answering the trial questions.
2019
- FDA. (2019). GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING
- QUOTE: Recruitment: Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the protocol’s inclusion and exclusion criteria during the clinical trial recruitment period. The number of subjects that must be recruited for enrollment into a study and meet the requirements of the protocol. In multicenter studies, each investigator has a recruitment target or defined number of subjects to be enrolled.
2018
- (CT, 2018) ⇒ https://clinicaltrials.gov/ct2/about-studies/glossary
- QUOTE: Recruitment status:
- Not yet recruiting: The study has not started recruiting participants.
- Recruiting: The study is currently recruiting participants.
- Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
- Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
- Suspended: The study has stopped early but may start again.
- Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
- Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
- Withdrawn: The study stopped early, before enrolling its first participant.
- Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
- QUOTE: Recruitment status:
2004
- (Frank, 2004) ⇒ Genevieve Frank. (2004). “Current Challenges in Clinical Trial Patient Recruitment and Enrollment.” SoCRA Source 2, no . February
- ABSTRACT: Achieving clinical trial research participant enrollment is essential to conducting a successful trial. Adequate enrollment provides a base for projected participant retention, resulting in evaluative patient data. Without sufficient patient retention from the time of study initiation to closeout, the number of remaining participants may prove to be too small a pool from which to derive conclusive proving or disproving the goal of the clinical trial sponsor. Obtaining final evaluative data is dependent on successful patient and principal investigator retention. Patients cannot be retained without an initial pool of enrolled volunteers. This initial pool of screened, then enrolled participants, depends on designing sound strategies for patient and investigator recruitment.