Solution
Insha answered on
Jun 15 2022
Protocol Feasibility 1
Protocol Feasibility 5
PROTOCOL FEASIBILITY
Table of Contents
Introduction 3
Protocol and protocol feasibility 3
Significance 3
Types of feasibility 4
Feasibility as a Team approach 4
Challenges around Recognition of protocol feasibility 5
Conclusion 6
References 7
Introduction
The possibility of conducting a clinical trial in a certain location, patient type, comparator, a dosage of investigational product, study design alignment, and environmental and Internal capacity are all part of a strong clinical trial feasibility process (Brunet, Price, & Baillot, 2021). Strong protocol feasibility enables the capacity to ca
y out the clinical study and a realistic evaluation. The protocol will be examined in this study, and the viability of the protocol will be determined. Furthermore, the obstacles that may exist in making a decisions regarding feasibility will be highlighted.
Protocol and protocol feasibility
In general, clinical trial feasibility is the process of determining whether or not a specific clinical study or program can be ca
ied out (Brunet, 2021). This is to be addressed in a certain geographical location with the general goal of completing projects on schedule, on budget, and on time.
Significance
In the last several years, the number of foreign scientists performing research under FDA IND has expanded dramatically. Patient recruitment causes 35% of study delays, about one-fifth of investigators do not enrol any patients, and roughly one-third enrol just 5% of evaluable patients (Doe et al. 2021). Because of these difficulties, most sponsors have chosen to conduct clinical trials in Africa, Asia, the Middle East, Eastern and central Europe, and Latin America.
In the absence of a well-organized network of clinical trial facilities, feasibilities aid in the identification of institution-specific or region-specific behaviours that may affect overall study completion (Lo, Chau, Choi, Yeung, & Demers, 2021). Global study teams supervise feasibility studies, but country offices (sponsor) or contract research groups ca
y out the actual work.
Types of feasibility
Feasibilities can be divided into three categories:
(a) Program level: this refers to the full program of research planned, such as a program on antibacterial in a variety of infections .
(b) Study level: This is particularly specialized to a certain research, such as an antibacterial in skin infections.
(c) Investigator or site level: this refers to the study being conducted in a specific clinic or hospital.
The goal of study and program level feasibility is to determine whether locations are suitable for a given clinical...