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Participant recruitment to the Coronary Primary Prevention Trial
Insights
Recruiting for the Coronary Primary Prevention Trial involved adapting strategies to enroll men with high cholesterol. Mass screening became essential for successful participant accrual in this heart disease prevention study.
Area of Science:
- Cardiovascular disease research
- Clinical trial methodology
- Public health initiatives
Background:
- The Coronary Primary Prevention Trial (CPPT) aimed to assess cholesterol reduction's impact on coronary heart disease (CHD) incidence.
- Participant eligibility criteria included men aged 35-59 with plasma cholesterol ≥ 265 mg/dl.
Purpose of the Study:
- To describe the participant recruitment process for the CPPT.
- To evaluate the effectiveness of different recruitment strategies.
- To provide recommendations for future clinical trial recruitment.
Main Methods:
- Initial recruitment relied on medical community referrals.
- Inadequate yield necessitated the adoption of mass screening methods.
- Participant accrual was monitored over an extended period.
Main Results:
- The initial referral strategy yielded insufficient participants.
- Mass screening significantly improved recruitment rates.
- 3810 participants were ultimately enrolled, exceeding the initial goal.
- The recruitment phase extended by 19 months beyond the original schedule.
Conclusions:
- Adaptable recruitment strategies are crucial for large-scale clinical trials.
- Mass screening can be an effective method for participant accrual.
- Lessons learned from the CPPT can inform future trial recruitment efforts.
Abstract:
This report describes participant recruitment to the Coronary Primary Prevention Trial, a long-term multicenter clinical trial sponsored by the National Heart, Lung and Blood Institute to test the effect of lowering plasma cholesterol on the incidence of coronary heart disease. The study protocol limited participation to men 35--59 yr of age with fasting plasma cholesterol of at least 265 mg/dl and in good general health. Recruitment began in July 1973, with a goal of 3550 entries within 18 months using referrals from the medical community as the primary source. The yield from this strategy proved inadequate, necessitating adoption of new recruitment sources which generally involved mass screening. These strategies led to the accrual of 3810 participants, although the pre-entry phase was extended by 19 months, i.e. through July 1976. Overall Trial recruitment experience is presented as well as results obtained from each major recruitment source and center and recommendations for conducting recruitment in future clinical trials.