Browsing by Subject "recruitment"
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Item A Comparative Analysis of Recruitment Methods used in Randomized Controlled Clinical Drug Trials(2019-05) Garud, Ashwini A.; Mathew, Stephen O.; Goulopoulou, Styliani; Anderson, Jessica; Maynard, BrianClinical trials are a crucial part of any drug development process. The reliability and validity of clinical trials depend on the successful recruitment of subjects. The overall goal of this project was to evaluate the effectiveness of subject recruitment methods used in Randomized Controlled Trials (RCTs) focusing on Major Depressive Disorder (MDD) and Postpartum Depression (PPD) studies. Recruitment methods (on-site and off-site) utilized in these trials were examined for their cost-effectiveness, recruitment return, including the number of subjects enrolled and the number of subjects randomized in the trial and subject demographics. Regarding cost effectiveness, on-site methods were found to be more effective in terms of recruitment return and less costly than off-site for both studies. There was a significant difference in race and gender when subjects were recruited from on-site versus off-site recruitment. For MDD study, a comparatively large number of enrolled and randomized participants were recruited from on-site recruitment methods as compared to off-site, this may be due to the number of physician referrals, indicating that physicians play a major role in subject recruitment. For the Postpartum Depression study, the number of enrolled and randomized subjects from off-site recruitment method was higher than those of on-site methods. Monitoring recruitment strategies implemented in the study and assessing their effectiveness would be helpful in employing strategies for future trials.Item Analysis of Factors that affect Recruitment Process and Effectiveness of Recruitment Methods in Treatment Resistant Depression Study(2019-12) Patel, Eva K.; Mathew, Stephen O.; Mathis, Keisa W.; Maynard, Brian; Anderson, JessicaIntroduction: The following Research Project is a Process Improvement Study to identify the factors affecting the recruitment process and identify best recruitment method in Treatment Resistant Depression Study. Adequate recruitment is essential to any study's success. Most studies report only the effectiveness of recruitment method, but very few report the cost of randomizations. This research project will analyze the effect of different recruitment methods in the Treatment Resistant Depression Study. The study will work on cost analysis which can be critical when deciding which recruitment methods to implement in Randomized Controlled Clinical Trials. Methods: For this research project, a study will be conducted to analyze the factors that affect the recruitment process and compare the effectiveness of different recruitment methods. Factors include demographical data such as age, gender, ethnicity, race and distance from site. Data for this study will be collected from a randomized double blind, active controlled "Treatment Resistant Depression Study" conducted at North Texas Clinical Trials, Fort Worth, TX. Data will include how many subjects were consented, how many of them were enrolled and how many of them failed the screening process. Results: All four recruitment methods were compared, based on the number of subjects referred, enrolled and randomized for the study. Statistical analysis showed that there was no significant difference between subjects referred, enrolled and randomized using all four methods (p-value: 0.1920). Analysis was performed on data which showed a statistically significant difference between the number of subjects referred and randomized through subject database and clinical connection (p-value: 0.0184). Total pooled data revealed race and distance from site being the only predicting factors on the outcome of being screened into the study. II Conclusion: Patient recruitment is a vital component in assuring the success of a clinical trial and can be time consuming. One method of recruitment alone is not sufficient to meet the target enrollment. It was difficult to prove significant effect of all the factors on the recruitment process due to small sample size, but future studies with larger sample size could potentially reveal more significant impact of factors associated with the recruitment process.Item Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment(BioMed Central Ltd., 2023-05-03) Kirn, Dylan R.; Grill, Joshua D.; Aisen, Paul; Ernstrom, Karin; Gale, Seth; Heidebrink, Judith; Jicha, Gregory; Jimenez-Maggiora, Gustavo; Johnson, Leigh A.; Peskind, Elaine; McCann, Kelly; Shaffer, Elizabeth; Sultzer, David; Wang, Shunran; Sperling, Reisa; Raman, RemaBACKGROUND: Recruiting to multi-site trials is challenging, particularly when striving to ensure the randomized sample is demographically representative of the larger disease-suffering population. While previous studies have reported disparities by race and ethnicity in enrollment and randomization, they have not typically investigated whether disparities exist in the recruitment process prior to consent. To identify participants most likely to be eligible for a trial, study sites frequently include a prescreening process, generally conducted by telephone, to conserve resources. Collection and analysis of such prescreening data across sites could provide valuable information to improve understanding of recruitment intervention effectiveness, including whether traditionally underrepresented participants are lost prior to screening. METHODS: We developed an infrastructure within the National Institute on Aging (NIA) Alzheimer's Clinical Trials Consortium (ACTC) to centrally collect a subset of prescreening variables. Prior to study-wide implementation in the AHEAD 3-45 study (NCT NCT04468659), an ongoing ACTC trial recruiting older cognitively unimpaired participants, we completed a vanguard phase with seven study sites. Variables collected included age, self-reported sex, self-reported race, self-reported ethnicity, self-reported education, self-reported occupation, zip code, recruitment source, prescreening eligibility status, reason for prescreen ineligibility, and the AHEAD 3-45 participant ID for those who continued to an in-person screening visit after study enrollment. RESULTS: Each of the sites was able to submit prescreening data. Vanguard sites provided prescreening data on a total of 1029 participants. The total number of prescreened participants varied widely among sites (range 3-611), with the differences driven mainly by the time to receive site approval for the main study. Key learnings instructed design/informatic/procedural changes prior to study-wide launch. CONCLUSION: Centralized capture of prescreening data in multi-site clinical trials is feasible. Identifying and quantifying the impact of central and site recruitment activities, prior to participants signing consent, has the potential to identify and address selection bias, instruct resource use, contribute to effective trial design, and accelerate trial enrollment timelines.Item Evaluating the Effectiveness of Third-Party Recruitment Campaigns in Small Site Management Organizations (SMOs)(2023-05) Murray, Michael S.; Sumien, Nathalie; Woerner, August E.; Willyerd, KarynRecruitment is often the most challenging aspect of a clinical trial. Finding the appropriate number of quality subjects takes time and may exhaust funds especially towards smaller site management organizations (SMOs). Standard recruitment strategies are often used such as physician referrals (patients given alternative treatments by being placing into clinical trials by their physicians) as well as database searches (extensive searches in patient networks by clinical researchers to find potential subjects). Both can be effective approaches but are often designed for larger research organizations with more available resources. One particular strategy, third-party recruitment, allows an outside company which specializes in marketing and recruitment to be assigned to finding potential subjects for clinical trials. This may reduce the burden of cost when allocating funds directly to this strategy rather than other recruitment strategies that may not work for smaller SMOs with limited resources and staff. Therefore, understanding which strategy is effective at enrolling subjects in a timely manner especially for SMOs with limited resources is vital for the continuation of clinical trials and their overall success to help improve scientific advancement. This study examined the process of recruitment in a small SMO with a focus on evaluating the effectiveness of third-party recruitment campaigns in comparison with standard strategies. Specifically, determine whether this strategy is better at acquiring more subjects to be enrolled compared to other strategies used for the same trials. It was hypothesized that third-party recruitment would be a more effective recruitment strategy for smaller SMOs with more limited resources compared to other standard approaches used in much larger organizations. This was done by comparing historical data from past Ear, Nose, Throat (ENT) related clinical trials at two sites involving third-party recruitment and the other strategies such as physician referral and database searches. It was found from our sample that third-party recruitment was better at recruiting and enrolling in sheer numbers. From the disaggregated portion of the analysis, third-party had a significant effect on recruiting subjects compared to the other standard approaches. However, no other statistical significance was observed in recruitment and enrollment numbers between the two groups but the data do trend towards promising outcomes when using third-party recruitment. The no statistical significance may be due to the limited amount of clinical trials and or the total number of subjects used in this study. Third-party recruitment campaigns may show some promise to helping small SMOs with limited resources to successfully recruit in a timely and costly manner but future research is needed to further investigate its efficiency in recruitment using larger sample studies.Item Factors that Impact Patient Enrollment in Clinical Trials(2014-12-01) Duong, Phong; Shi, Xiangrong; Gwirtz, Patricia A.; Lovely, Rehana S.Introduction: Medical progress, now more than ever, demands clinicians to provide tangible proof over sound hypotheses. This is where clinical research steps in as a combatant to the unknown provoked by logical theories and sound hypotheses. The one constant in clinical research is that recruitment strategies are always changing. Analyzing factors that impact recruitment will effectively serve to improve the quality of clinical research conduction. Objective: The purpose of this project is to determine if there are certain factors in an individual’s life that has influenced them to participate in a clinical research study. Methods: To address the specific aims of the practicum project, a fifteen-question survey was administered to subjects enrolled in four different studies at Plaza Medical Center of Fort Worth. Data analysis was conducted using the Chi-Square Significance Test. Results: The data yielded Chi-Square values of 11.355 (Personal Influence), 14.129 (Family Influence), 186.242 (Research Staff influence), 40.581 (Financial Influence), and 56.871(Physician Influence). The values were tested under the following parameters: α=0.05 with four degrees of freedom. Conclusions: This leads to a rejection of the null hypothesis and implies that there are factors in a subject’s life that influences their decision to participate in a research study.Item Obstacles Associated with Physician Referral of Patients into Clinical Trials(2017-05-01) Torrez, Nick; Hodge, Lisa M.; Mathew, Stephen O.; Jung, Marianna E.Understanding the safety and efficacy of potential new medications relies on evidence gained through the participation of subjects in clinical drug trials. Many clinical trial sites struggle with recruitment of suitable participants which can delay the progress of drug development. Physicians can play a significant role in influencing patients to enter into a clinical trial, however many physicians due not utilize their unique position to facilitate the recruitment of patients into clinical trials, which may help to advance medical science and improve future treatment options. The lack of participation by physicians in the referral of patients into clinical trials (Crosson et al. 2001; Daugherty C, 1995; Jenkins and Fallowfield, 2000; Lara et al., 2001) can potentially be explained by various obstacles. We propose that these obstacles may be issues such as time, lack of knowledge about clinical trials, lack of clinical trials suitable for patients, language barriers, conflict of interest, communication with local investigators, and trust in medical researchers.Item Qualitative Analysis on HIV/AIDS Clinical Trial Recruitment Marketing Practices(2022-05) Dapoz, Anthony M., Jr.; Simecka, Jerry W.Recruitment continues to be one of the largest barriers to clinical trial success. Based on review of clinical trial marketing literature, there are no marketing industry standards established for recruitment of HIV/AIDS clinical trials. The purpose of this study was to begin finding optimal marketing recruitment strategies in HIV/AIDS clinical trials research. A literature review yielded 20 articles detailing recruitment marketing practices. A ClinicalTrials.gov search found 57 trials meeting inclusion criteria. Data extracted included recruitment strategies, original enrollment goals, estimated enrollment goals and actual enrollment goals. Regression analysis found no significant relationship between marketing strategies and recruitment rate. Added financial and managerial considerations should be incorporated with a robust site level marketing campaign to optimize recruitment potential.Recruitment continues to be one of the largest barriers to clinical trial success. Based on review of clinical trial marketing literature, there are no marketing industry standards established for recruitment of HIV/AIDS clinical trials. The purpose of this study was to begin finding optimal marketing recruitment strategies in HIV/AIDS clinical trials research. A literature review yielded 20 articles detailing recruitment marketing practices. A ClinicalTrials.gov search found 57 trials meeting inclusion criteria. Data extracted included recruitment strategies, original enrollment goals, estimated enrollment goals and actual enrollment goals. Regression analysis found no significant relationship between marketing strategies and recruitment rate. Added financial and managerial considerations should be incorporated with a robust site level marketing campaign to optimize recruitment potential.Item Recruitment Strategies and Fulfilling Enrollment at a Site Management Organization(2014-12-01) Shell, Mark S.; John A. Schetz; Dong-Ming Su; Heema MarwahMeeting enrollment goals in a timely fashion is among the most substantial challenges faced by a site conducting randomized clinical research trials. In order to effectively meet the challenge, the site must prepare an effective recruitment plan prior to opening enrollment for a study. Formulating such a plan relies on three key factors: study protocol, study indication, and site budget. Data from previous similar studies can be helpful in guiding the allocation of patient recruitment funds and workload. This practicum research project applies a number of recruitment metrics proposed in the literature to the subject accrual efforts of a site management organization in order to objectively quantify performance.Item Recruitment, Retention and Compliance in Randomized, Phase III Clinical Trials Involving Obese Patients Diagnosed with Type 2 Diabetes Mellitus with Respect to Weight Loss.(2012-12-01) Mithani, Moez S.; Robert WordingerHuman research and clinical trials face many obstacles that prevent or hinder efficient and reliable data and results from being collected, analyzed, and reported. This is especially true in clinical trials involving type 2 diabetes. The purpose of this study is to understand issues relating to the recruitment, retention, and compliance of Type 2 diabetic subjects in phase III clinical trials. The data used in this study was collected from a parent study already conducted at the investigator site. The results indicate that issues with recruitment are attributed primarily to the inclusion/exclusion criteria, especially HbA1c values and changes in medication usage. Decreases in retention were primarily due to a lack of involvement in the control group on part of the subject and the coordinator and also due to a lack of significant results in a timely manner. Issues with compliance were found to be due to a lack of discipline on the part of the subject to make lifestyle adjustments and a lack of time in the daily schedule to add an exercise program and employ healthy dieting regimen.Item RESEARCH PARTICIPANTS' BELIEFS AND ATTITUDES TOWARDS CLINICAL RESEARCH STUDIES(2013-04-12) Thamby, RohanPurpose: To assess former and current patients' beliefs and attitudes towards clinical research to determine if it correlates with the likelihood the patient would participate in a future clinical research study. To assess former and current patients' beliefs and attitudes towards recommending to others to participate in clinical research. To identify what factors encouraged or discouraged the patient from future research study participation, and methods in which to improve the likelihood of joining a clinical research study. To determine if former research study participants show interest in using the Internet to gather information regarding clinical research studies. To obtain demographic data in order to determine if there is a more concise plan for patient recruitment. Methods: A survey was created that could be distributed in person or over the telephone. The research population of TPCCC with available phone numbers and who were not immediately screen failed were offered the opportunity to complete the surveys. The data was taken and multiple variable chi square tests were performed for each question and compared with demographics such as age, race, and gender to address the project aims. Results: With zip codes and ethnicity having a limited impact, the strongest correlations came from age and gender vs. why the participant joined, why they would participate again, and their level of interest in finding alternative ways to learn about research. Patients who have not used the Internet to locate research studies but who had an interest in future research participation showed an extremely strong interest in finding information through the internet. Patients who had no complaints and were inclined to participate in the future were also highly likely to share their experiences with potential patients. Conclusions: The results showed that the majority of former and current patients are willing to participate in future clinical studies, are more likely to recommend others towards participating, and are interested in learning what the Internet has to offer in terms of providing information about clinical research studies.Item The Analysis of Current Recruitment Methods: Measuring the Potential of Social Media in Clinical Research Trials(2015-12-01) Nguyen, Denise T.; John A. Schetz; Dong-Ming Su; Patricia A. GwirtzClinical research has an important role as the intermediate step before an investigational drug or procedure is approved for distribution to the public. Before an investigational drug is approved, researchers must prove there is a benefit to the public by conducting an ethical clinical research trial. This process relies on recruiting the study population that is representative of the general population. If too few individuals participate, this could skew the data and prevent the eventual approval of an investigational drug or procedure. Recruiting study participants for certain populations has become increasingly difficult, which is why this practicum report explores the communication habits of the population around Baylor All Saints Medical Center via survey. The results of this survey will help Baylor Research Institute in Fort Worth, Texas better address clinical trial recruitment by possibly implementing social media into their current recruitment practices.