The many faces of recruitment in a randomized controlled trial

Bernardine M Pinto1, Shira I Dunsiger2

  • 1College of Nursing, University of South Carolina, 1601 Greene Street, Rm 302B, Columbia, SC 29208, USA.

Abstract

Insights

Targeted mailings were the most effective recruitment method for a physical activity randomized controlled trial in breast cancer survivors, yielding higher randomization rates and lower costs compared to other strategies. Combining recruitment methods is key for achieving trial goals.

Area of Science:

  • Clinical Trials
  • Public Health
  • Cancer Survivorship

Background:

  • Effective study recruitment is crucial for the success of randomized controlled trials (RCTs).
  • Recruitment challenges can lead to costly delays and underpowered studies due to smaller sample sizes.
  • Optimizing recruitment strategies is essential for robust clinical trial design and implementation.

Purpose of the Study:

  • To evaluate various recruitment methods (targeted mailings, brochures/flyers, social media) in a physical activity RCT for breast cancer survivors.
  • To assess the relationship between recruitment methods and participant eligibility, randomization rates, participant characteristics, and retention.
  • To determine the cost-effectiveness of different recruitment strategies per randomized participant.

Main Methods:

  • Analysis of screening data from 874 women undergoing an RCT for physical activity adoption and maintenance.
  • Calculation of costs per randomized participant for each recruitment method.
  • Comparison of baseline demographic characteristics across recruitment methods and between randomized and retained participants.

Main Results:

  • Recruitment method significantly impacted participant accrual rates from screening to randomization (p < .05).
  • Targeted mailings achieved the highest randomization rate (88.2%), while brochures/flyers had the lowest (0.4%).
  • Significant cost differences were observed between methods (p < .001), with targeted mailings being the most cost-effective.

Conclusions:

  • The RCT successfully recruited and retained breast cancer survivors, demonstrating the feasibility of physical activity interventions.
  • Combining multiple recruitment strategies is recommended to meet accrual targets in clinical trials.
  • Recruitment methods vary significantly in cost and effectiveness for attracting participants eligible for randomization.

Related Concept Videos

Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
8.6K
Group Design02:01

Group Design

The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between...
10.0K
Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
3.7K
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.3K
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.0K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
266