Browsing by Subject "Patient Selection"
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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 Analysis of Patient Recruitment Methods in Clinical Trials of Different Heart and Lung Diseases(2018-05) Sido, Oghenevovwero V.; Mathew, Stephen O.; Cross, Deanna S.; Felius, Joost; Propps, Jessica; Martits-Chalangari, KatalinPatient recruitment is key to the success of any clinical trial, as clinical trials cannot be conducted without the willful participation of subjects. However, clinical trial recruitment has always been a great challenge in clinical studies. This practicum project conducted over an eight-month period, compares three different methods of subject recruitment into 2 clinical research studies conducted at the Heart & Lung Transplant and Pulmonary Research Department of Baylor Scott & White Research Institute, Dallas. A total of 333 potential subjects were identified via EHR screening or referred by physicians or signed up on the clinical trial portal to be contacted about the study. 108 patients were referred by physicians, 212 patients were identified via EHR screening and 13 patients signed up on the online clinical trial portal to be contacted for a study. By comparing the method of patient recruitment into clinical studies, we can ascertain what method works best in recruiting patients for clinical trials. The three recruitment methods are: Physician Referral, EHR Screening and Online Portals. We hypothesize that Physician referral is a more successful method for enrolling patients into clinical studies of different heart and lung diseases.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 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 Remote Recruitment and Data Collection and Its Effect on Demographics and Outcome Variable Scores(2019-12) Cooper, Savannah B.; Dory, Ladislav; Licciardone, John C.; Gwirtz, Patricia A.; Kearns, CathleenBACKGROUND: Technology continues to push different aspects of research forward, including new recruitment methods and updated data collection/management. More and more, researchers are beginning to use social media as a valid recruitment method. Studies are also moving toward more remote methods of consenting research subjects and data collection. Several studies were found to use only online recruitment methods and many showed that Facebook was an effective method [1]. With this shift toward more remote and more technologically advanced research, it is important to explore whether increasingly adding technology to research studies shifts the study population in a way that impacts outcome measures. Based on previous research, studies with mainly remote modes of recruitment and data collection have a younger, more educated and less diverse population [2] [3] [4]. HYPOTHESIS: (1) By relying on technology and fewer interpersonal interactions, the demographics of the study population will shift toward younger participants, increased employment status, higher education level, fewer minority participants, and gender will shift to a more even balance of males to females. (2) Changes in the population demographics that are driven by technology will also increase the SPADE cluster score (Sleep disturbance, pain, anxiety, depression, and low energy/fatigue). Specific Aims for both Hypothesis I and II include; (1)To examine the demographics of the study population and outcome variable scores when looking at technology-focused recruitment methods implemented at different points in the study. (2) To examine the difference in demographics and outcome variable scores when looking at effects of the recruitment method alone (without the time of enrollment consideration). METHODS: Survey data from the baseline visit of 583 subjects in the PRECISON Pain Research Registry were used. The subjects were divided into groups based on changes in recruitment methods over the course of the study to evaluate how changes in primary recruitment methods may have shifted the population. The same 583 subjects were also divided into two groups: traditional methods and online methods to evaluate the effect of recruitment methods alone on the population. Demographics and the SPADE score outcome variables were analyzed using chi-squared and t-test analysis to see if there was a significant change between the groups. RESULTS: For Aim 1, there were no statistically significant changes in the population demographics or the SPADE outcome measures with the only exception being gender. For gender, the proportion of females has significantly increased as the reliance on digital methods, such as online newsletters and social media, has increased. For Aim 2, comparing enrolled subjects who were recruited through traditional methods such as flyers in clinics and the community to subjects who were recruited through online vehicles regardless of when they enrolled in the study, there was a significant difference in every demographic except ethnicity. The online group showed a significantly younger, more educated, and less diverse population. DISCUSSION: Hypothesis I was not supported by Aim 1 but was supported by Aim 2. This means that over the course of the study time the population has not changed dramatically, possibly because a mix of traditional and online recruitment methods is still being used. However, the population that was recruited using online methods was significantly different than the population recruited through traditional methods. It is important to keep this in mind as the study moves forward. Hypothesis II was not supported by either aim. Aim 1 showed minimal changes and Aim 2 showed a trend rejecting this hypothesis. Currently, there is no data to support that technological advances would have an increase the outcome variable scores.