Search In this Thesis
   Search In this Thesis  
العنوان
A Structural Equation Modeling of Predictive Factors for Patient Enrollment in Clinical Trials /
المؤلف
El Sayed, Dina Ahmed Reda Mahmoud .
هيئة الاعداد
باحث / دينا احمد رضا محمود السيد
مشرف / مها عبد الحميد غانم
مناقش / ليلى محمد نوفل
مناقش / منى حسن احمد
الموضوع
Biostatistics. Modeling- Patient.
تاريخ النشر
2023.
عدد الصفحات
188 p. :
اللغة
الإنجليزية
الدرجة
الدكتوراه
التخصص
الصحة العامة والصحة البيئية والمهنية
الناشر
تاريخ الإجازة
03/05/2023
مكان الإجازة
جامعة الاسكندريه - المعهد العالى للصحة العامة - Biostatistics
الفهرس
Only 14 pages are availabe for public view

from 188

from 188

Abstract

Our goal was to determine which physicians’ characteristics, attitudes, and organizational context factors were linked to better patient enrolment in clinical research among the investigators who participated in Alexandria during the period 2011 to 2019. We proposed a hypothesis that physician individual characteristics, such as age, tenure, medical specialties, experience, organizational factors (such as strategies and processes aimed to enhance enrolment), and attitudes, beliefs, and values towards participating in clinical research, were expected to have a direct impact on patient recruitment. We furthermore hypothesized that physicians’ personal characteristics and organizational context would impact their attitudes regarding clinical trial participation, which would in turn estimate the patient enrolment. We assessed the enrolment in clinical trials during the period from 2011 to 2019 among 200 investigators participants utilizing structural equation modelling. There are two types of data sources, questionnaires with physician participants, and the Ethics committee data base. The analysis resulted that Physicians who had a more favourable attitude toward clinical trials enrolled more patients than those who had a lower positive attitude. Furthermore, physicians that had more assisting, boosting strategies and procedures in circumstances to enhance enrolment (such as Trainings are given, as well as assistance in screening and enrolling patients, as well as incentives to enrol patients) also have indirect significant effect on enrolled more patients through the attitude. Physicians’ characteristics, tenure, and other specialities than hemato_oncology and internal medicines have significant negative direct effect on increasing enrolment while physician experience in clinical trials has significant positive effect on enrolment. Physicians’ characteristics didn’t indirectly effect the patient enrolment through physician attitudes except the tenure ( number of years since graduation from medical school) have significant indirect effect Via physician attitudes. Finally, after the examination of the individual physician characteristics and attitudes, as well as organizational factors, using structural equation modelling techniques to see whether or not they influenced directly or indirectly patient enrolment in clinical trials among participant physicians; It was concluded that physician attitudes had significant positive direct effects, but organizational factors have significant indirect effects, on physician patients’ enrolment through physician attitudes. Our findings could be utilised to design physician focused strategies for expanding clinical trial participation. Administrators must ensure that physicians have access to staff who can support screen and enrol patients. Our findings further highlight the necessity of selecting physicians for volunteer clinical research who have attitudes and values in line with the clinical research objectives. Given the active participation of physicians, is a critical predictor of patient enrolment in clinical trials, these interventions could increase the total number of patients participated in clinical trials.

6.2 Conclusions
The Findings of this thesis are significant in the context of boosting physician participation in clinical research as a volunteer and this in turn will influence the enrolment of patient in clinical trials. Our findings propose three methods for increasing engagement. First step is to guarantee that physicians’ values, beliefs, and attitudes are in line with the research objectives. As an example, a crucial driver of a Research’s success is hiring physicians who value clinical trials, consider them important, and believe they can do so. Second, the organisation should think about aiding investigators conducting clinical trials, for example team members to assist with consenting, screening, and enrolling patients, incentives for meeting enrolment goals, and trainings on the most recent research Guideline. Such approaches will directly affect physician attitudes and encourage active physician involvement in patient recruitment.
Third, the improvement of clinical trial design and the studying of the factors related to patients, to identify and map factors that impact patient participation in clinical trials. It will enable a comprehensive understanding of all the mechanisms that influence patient participation. This thesis built a new knowledge that can be used to improve participation in clinical trials. It is our intention that by comprehensively investigating these points, there may be an opportunity to inform health policy that better supports the clinical trial sector so that a larger community of patients and their families can benefit and access to better therapy.

6.3 Limitation and Recommendation
Our thesis has a few weaknesses and drawbacks. To begin, we only surveyed physicians who had already participated in clinical trials. These physicians have already positive attitudes at least on certain level to participate in clinical trials which may bias the results. Second, we are still not able to account for variation in the number of possibly eligible patients. Physicians highlighted a variety of reasons for recruitment failure, including research complexity, too many exclusion criteria, and missing patient opinion data. As a result, we are not able to discriminate between investigators who failed to invite patients to participate in clinical trial and patients who refused the participation, and we were unable to add patient-factors in the study thesis model of analysis due to a lack of data. We can’t consider variations in disease severity, co-morbidities, age, or any other characteristics that have an impact on eligibility. In the end, the patients who take the final decision on whether to participate in clinical research. Third, because of this we could only account for approximately 25% of the variation in enrolment. To enhance the amount of variation explained, future research may want to include other parameters in the model, such as patient-level features. Which may assist in explaining variance in enrolment in clinical trials, so there are clearly other important determinants of patient enrolment that we were unable to capture in thesis analysis.
Our thesis, it would be the first in Egypt to investigate physician characteristics and attitudes predictors of patient recruitment in clinical trials. Second, it sets the foundation for physician-Focused strategies to enhance patient enrolment in clinical studies. We can speed up the process of identifying prospective breakthrough medicines and new interventions that can improve patient outcomes by expanding the number of patients who take part in clinical trials. Our recommendation for future study, we should concentrate on clinical trial elements and patients’ attitudes and perceptions that both encourage and hinder patient participation to improve enrolment.