Browsing by Subject "clinical research"
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Item Clinical Research: Drug Studies and Device Trials, Theory and Approach(2002-07-01) McCormick, Timothy Chad; Rustin Reeves; Don Pesca; Dellas WeisA clinical trial is composed of four different phases. Each of these phases serve a purpose such as testing safety, efficacy, and dosage. These phases are essential to provide the best possible model for mass use of a drug or a new device. Drug studies differ from device studies in their design and their delivery. In this case, a post-operative pain medication was tested, as well as a differential study between two types of cutting devices used in laparoscopic cholecystectomy. The post-operative pain study is a phase III study that is testing the efficacy, safety, and the pharmacokinetics of a proposed drug. The device study is considered a phase IV study because it is evaluating two commonly used techniques for laparoscopic cholecystectomy. Both of these techniques have previously been approved by the FDA and are mass marketed. These two studies were followed for six weeks and evaluated for protocol design, differences and similarities, and for hands on experience in the clinical research arena. Upon completion of the six week opportunity, it is evident that clinical research is a viable piece of medicine today. Following these two studies allowed for an understanding of the differences and similarities encountered when executing a drug study, as well as a device study. The complexities of the two studies were evaluated, and without doubt, the drug study included much more paper work, patient testing, inclusion/exclusion criteria, study evaluation, and most of all, man hours. All in all, this was a very rewarding experience that allowed for a greater understanding of the implementation and value of today’s clinical research.Item Continuous quality improvement at the clinical research site: implementing methods for coordinators in the Heart and Lung Transplant and Pulmonary department at Baylor Scott and White Research Institute(2020-05) Norgan Radler, Charlene R.; Mathew, Stephen O.; Chaudhary, Pankaj; Martinez, Horacio; Felius, JoostNorgan Radler, Charlene R. Continuous quality improvement at the clinical research site: implementing methods for coordinators in the Heart and Lung Transplant and Pulmonary department at Baylor Scott and White Research Institute Master of Science (Clinical Research Management), April 2020 Introduction: The following research project is a Quality Improvement (QI) study to assess resource utilization for six ongoing clinical trials and evaluate the impact of quality improvement methods on the completion of critical trial activities in the Heart and Lung Transplant and Pulmonary (HLTP) department at Baylor Scott and White Research Institute (BSWRI). Methods: The project design is a case series in which observations were made on research staff before and after an intervention, with no control group. Non-probability sampling with purposeful, maximum variation was used due to the study's qualitative research design. Metrics were collected regarding the completion of key trial activities of subject screening, subject enrollment, and data entry before and after intervention using a spreadsheet tool. Collected metrics were reviewed to identify areas for improvement and QI interventions were designed and implemented to reallocate resources as appropriate. The data was maintained in a run chart to monitor changes during the pre-intervention and post-intervention periods. Statistical analysis was performed on the data to evaluate the effect of the intervention. Results: The Wilcoxon Signed-Rank test was used to statistically analyze differences in medians of activity metrics across all studies before and after intervention. All variables improved in the direction of the applied interventions except time screening subjects and data entered in the electronic data capture (EDC) system. Median differences were found statistically non-significant, except the combined variable of number of open queries and case report forms (CRF) not entered weekly which demonstrated a statistically significant decrease following intervention. Median time screening subjects demonstrated a non-significant decrease following intervention while median number of subjects screened showed a non-significant increase. Median time enrolling subjects and median number of subjects enrolled increased post intervention, but statistical testing was not performed due to the small sample size below the minimum critical threshold required. Median time entering data in the EDC demonstrated a non-significant increase following intervention while median number of CRFs entered in the EDC showed a non-significant decrease. Conclusion: Implementation of the quality improvement process for clinical research staff provided a tool for our site to continuously assess and improve trial outcomes. Five of the seven variables receiving quality improvement interventions improved in the direction of the intervention, with one demonstrating a statistically significant difference. The small sample size used may have decreased the power of the study to detect statistical significance. Future studies should be completed to apply the quality improvement methodology used to a larger sample size. In conclusion, this study established 'proof of concept' for the completion of future, larger-scale quality improvement projects at our research site.Item CT-based assessment of lower limb surface area, volume, and tissue composition: Implications for ecogeographic rules of thermoregulation(2022-05) Carey, Barclay L.; Maddux, Scott D.; Romero, Steven A.; Gonzales, LaurenAnthropological research into human climatic adaptation has shown that global variation in skin surface-area to body volume ratio is generally consistent with theoretical predictions of ecogeographic rules. NSF has funded a research project in which human subjects will undergo full-body computed tomography scanning, and physiological testing during exposure to climatic extremes, to permit direct evaluation of associations between morphological variation and thermoregulatory physiology. This project entailed the development of analytical methods for the NSF project, which will be used to 1) compare CT-derived SA/V ratios to traditional estimation methods, and 2) to evaluate potential volume differences in internal tissue compositions (e.g., bone, muscle, fat).Item Enhancing the Effectiveness of Serious Adverse Event Reporting in Clinical Trials: A Framework for Continuous Improvement(2023-12) Bonsu, Chelsea O.; Chaudhary, PankajItem Getting Lost in Translation: The Dangers in Literal Translation(2008-04-18) Pena, Itzel; Gwirtz, Patricia A.; Gladue, Brian; Espinoza, AnnaCurrently 16 million Hispanics in the U.S. do not speak any English making the need for Spanish translation apparent. Within the clinical research realm, accurate translation is important for complete comprehension of the informed consent process, as it is the application of the ethical principle of respect for persons (autonomy). This study found that literal translations might not always be the best form of translation. Instead, non-literal translations may offer better comprehension of the consent process. However, the effect of being bilingual and attaining high education levels are significant factors influencing the comprehension of the informed consent document. Additionally these factors may actually facilitate the understanding of the consent form more than the literal and non-literal translation. Lastly, the perception and meaning behind different translations can affect comprehension of consent concepts. Subjects preferred to be called participants showing that the two different translations can hold different meanings.Item Industry Perspective on Clinical Investigative Sites: Maximizing Sponsor Return on Investment(2010-07-01) McDermott, Patrick W.; Dr. Patricia GwirtzItem Level of Understanding of Participation in a Clinical Trial by Alzheimer's Subjects and its Correlation to their Neuropsychological Test Scores: A Pilot Study(2009-12-01) Patki, Deepti; Dr. Patricia GwirtzItem Long Term Compliance and Withdrawal Rates in Gynecologic Oncology Clinical Research Studies(2003-12-01) Kersey, Jen Kelley; Robert Kaman; LaChelle Arredondo; Robin NewmanOncology is an area of study that is greatly affected by time. Patients with cancer need safe and effective treatment immediately. For some, current treatments have not worked to eliminate their disease. Their recurrent condition reinforces the need for safer and more effective treatment. This treatment must not only destroy the cancerous cells, but it must also allow for the continuation of their lives. This life can be measured by time and quality. Ideally, both would be maximized for proper treatment, yet current science has not found this model cure. For some regimens, quality of life could be maximized at the expense of quantity of life and vice versa. Both the patient and the healthcare provider should evaluate the balance of expectations. The potential of each life should be maximized for length and quality. The investigator/physician must do everything in their power to ensure that the patient’s needs are met medically. In treatment involving recurrent cancer patients, time is of the essence. Therapy, in every form, must be given immediately to extend and improve their remaining lives. If QOL assessments can predict the outcome of retention, acknowledgement of the subject’s well-being can allow for greater insight into the physical and emotional effects of the experimental treatment. The use of this information can help future generations of cancer patients by providing data that describes the therapy. The study of “Long Term Subject Compliance and Withdrawal Rates in Gynecologic Oncology Clinical Research Studies” is necessary for the evaluation of QOL assessments to subject retention, patient care practices in research and private practice may be affected through incorporation of the QOL assessment. There are many benefits that may result if significance is found in this study. The main objective of the QOL assessment is to observe the QOL of the subject in relation to the effect of the treatment on the individual. If subject retention can be predicted from the evaluation of QOL assessments, future clinical research studies, in gynecologic oncology and beyond, may modify their protocols to include the assessments. Improved subject retention will ultimately improve the accuracy of data collection. Improved accuracy will help evaluate the outcomes of treatment for cancer patients. If the QOL assessment shows a correlation to subject retention, the survey could be used as a tool, not only to assess the patient’s well being, but also to predict withdrawal. This project could identify “at-risk” factors of the subject population. Subjects who are at-risk for withdrawal should be followed closely. Excluding subjects that meet the clinical protocol would be unethical. To protect the validity of the study and ensure ethical measures are taken, those subjects that have factors associated with drop-out should be enrolled in the study and monitored closely. The survey may give insight to the types of ancillary or palliative care that may be needed during the patient’s fight with cancer. This research hopes to identify that quality of life assessments are an integral dimension of the research practice. The care of the patient rests in the hands of the physicians providing treatment. They are responsible for the needs and best interest of the patients. Wide discrepancies between the rating of specific outcomes of treatment by the patient and physician have been noted in current literature. This study may help show that the patient driven quality of life assessment is an important aspect of patient care, and should be integrated as a common tool for the care of gynecologic oncology patients. The use of this tool outside of the research setting should also be explored. Future studies in quality of life, beyond that of gynecologic oncology, may be investigated. This study hopes to initiate further research for the quality of life assessment because the QOL assessment gives data regarding well-being from the patient’s perspective. Future studies should also research the confounding factors that may influence subject withdrawal. These additional collaborative factors may contribute to compliance or those “at-risk” for drop out. By maximizing subject retention and protecting subject safety, healthcare research can provide results that reflect the true investigational question.Item Nutrition, Dementia and Depression in an Ambulatory Geriatric Care Center(2005-05-01) Birmingham, John F.; Daisha Cipher; Douglas A. Mains; Thomas J. FairchildBirmingham, John F., Nutritional Risk, Dementia Factors and Depression in an Ambulatory Geriatric Care Center. Master’s of Public Health (Clinical Research), May 2005, 60pp., 7 tables, 2 figures, reference list, 56 titles. Dementia is a major public health problem in the aging population. Depression, nutritional risk and declining self-efficacy are broadly listed risk factors for dementia. Cross-sectional patient data was obtained by chart review of ambulatory community-dwelling elderly patients screened for depression, dementia factors, levels of independence in activities associated with daily living and nutritional risk. The statistical coefficients of the correlational relationships between nutritional risks, dementia factors, depression levels and levels of functional capacity were examined using path analysis. Two models depicted the composite of instrumental activities of daily living items (IADLs), as they related to the dependent variables models, nutritional risk, dementia factors, and depression levels. The model which regressed the IADLs composite variable against depression and dementia factors indicated a good fit (X2=0.00, p=0.01). Attempts to match screening data with diagnostic follow-up data were unsuccessful. Only 12 matches occurred between the GAP and CARE databases (N=256, N=1470).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 Quality Assurance Training: Will a New Training Intervention Improve Data Collection of the Texas Emergency Medicine Research Associate Program (TEMRAP)?(2018-12) Saldana, Miguel Antonio; Hodge, Lisa; Pierce, Ava; Krishnamoorthy, RaghuIntroduction: Data collection is vital for the success of a clinical research project. The purpose of this practicum was to address the inadequate data collection by the Texas Emergency Medicine Research Associate Program (TEMRAP) research associates (RAs). The primary goal was to incorporate a more efficient training method to reduce the RAs' error rate in the documentation. The secondary aim of this experiment was to determine if RAs' knowledge of clinical research studies and/or their self-confidence when enrolling a patient had an effect on quality of data collection and if these variables could be improved by a new training method. Methods: A randomized clinical trial was used to evaluate the efficacy of simulated clinical research enrollment training as a teaching and/or learning method to reduce the error rate in submitted research packets by RAs. The returning RAs were randomized into an intervention group with new training (simulations) and a control group with current training (didactic presentations). A self-confidence survey and a knowledge questionnaire were completed by RAs pre/post-training and one-month follow-up. Quality of data collection was measured by comparing the error rates of data collection in completed clinical research enrollment packets submitted by the RAs in the intervention group versus the control group. Results: Results showed no statistically significant difference in the level of knowledge, confidence or error rates between the patient enrollment simulation (intervention) group and the didactic presentations (control) group after their respective training (p [greater than] .05). However, there was a statistically significant increase in knowledge and confidence post-training in patient simulations group. A significant association was present between confidence and error rate but not between knowledge and error rate for research associates in either training group. Conclusion: Clinical simulation training was not a significantly more effecting training method compared to current TEMRAP didactic presentation training. Even though knowledge and confidence did increase post-training there was no significant difference between the two types of training. Future experiments should explore the possibility of combining the two types of training and observing other potential variables affecting the quality of data, such as research associates' motivation. Additionally, the need for a larger sample size and enrolling participants with no prior research experience should be explored for significant results.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.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 Richards, David M., D.O. (1989)(1989-08-31) Richards, David M.; Alter, JudyPresident of TCOM since 1985, Dr. Richards joined the college as vice president of academic affairs in 1981. Under his administration emphasis has been placed on academic excellence and a continued effort toward basic and clinical research. Interviewed by Judy Alter, August 31, 1989Item Richards, David M., D.O. (1994)(1994-01-25) Richards, David M.; Hailey, BlakePresident of TCOM since 1985, Dr. Richards joined the college as vice president of academic affairs in 1981. Under his administration emphasis has been placed on academic excellence and a continued effort toward basic and clinical research. Interviewed by Blake Hailey, January 25, 1994Item Survey of Clinical Research Industry Site Success among Coronavirus Disease 2019 (COVID-19) Pandemic(2021-05) Barrett, Ethan W.; Chaudhary, Pankaj; Mathew, Stephen O.; Chaudhary, Pankaj; Su, Dong-MingCOVID-19 had a great impact on the Clinical Research Industry. While past research has focused on past challenges to site success, it has not been done while a pandemic was ongoing. This study explores potential variables, such as site demographics, to clinical site success during a pandemic and seeks to implement potential strategies. With these new strategies, sites may find success in normal times as well in case an event like this pandemic happens again.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.