Expert Clinical Trial Protocol Development Services
Before a clinical trial can be started, a Clinical Trial Protocol must be developed. This document has the role to describe the pathway in which the study will be conducted, meaning that all details expected in the particular trial must be indicated at the protocol.
Besides acting as a map for the procedure, the protocol also ensures safety for the subjects and the integrity of the data collected, being a vital part of the entire process that makes possible providing patients all around the world, new and life-saving technologies.
Clinical Trial Protocol development and complexity depends mainly upon the type of clinical study being conducted. An experienced CRO like Eclevar is ready to design all your documentation as well as assist your study to bring your product to the targeted market.
A Clinical Trial Protocol Development overview
The development of a Clinical Trial Protocol is a critical step in the initiation of any clinical investigation. It acts as a blueprint, guiding researchers and ensuring that the trial is conducted ethically, following core scientific principles.
By meticulously designing and complying with the protocol, researchers can navigate the landscape of clinical trials while prioritizing the safety of participants and maintaining the integrity of the collected data.
According to the ICH Good Clinical Practice guidelines, a protocol should indicate the following topics:
- Basic information (title page)
- Background Information
- Study Design
- Selection and Exclusion of Subjects
- Treatment of Subjects
- Assessment of Efficacy
- Assessment of Safety
- Adverse Events
- Discontinuation of the Study
- Quality Control and Assurance
- Data handling and Recordkeeping
What should be included in the protocol?
Clinical Trial Protocol development involves the collaboration of different stakeholders, including principal investigators, researchers, clinicians, statisticians and ethics committees, making possible the study to lead to reliable and meaningful results.
In order to ensure standardized practices, the ICH (International Council for Harmonisation) Good Clinical Practice guidelines provide specific recommendations on what topics should be included in a protocol. Get to know these essential components:
Basic information (title page)
The protocol begins with a title page that provides general information about the study, including the title, protocol number, version, and effective dates. Other information expected to be in the first portion of the protocol are:
- Name and address of the sponsor and monitor
- Name and address of the sponsor and monitor
- Name and title of the person(s) authorized to sign the protocol and the protocol adjustment(s) for the sponsor
- Name, title, address, and telephone number(s) of the sponsor’s medical expert
- Name and title of the investigator(s) who is (are) responsible for conducting the trial
- Address and telephone number(s) of the trial site(s).
- Name, title, address, and telephone number(s) of the qualified physician, who is responsible for all trial-site related medical decisions
This section provides an overview of the context and rationale for conducting the research. It outlines the scientific background, existing knowledge gaps, and the significance of the proposed study.
Objective and purpose for the trial
Here, the specific objectives and purpose of the research are clearly defined. This section articulates the research questions, hypotheses, or aims that the study seeks to address.
The trial design section describes the overall design of the research, including whether it is a randomized controlled trial, observational study, or another type of design. It outlines the study arms or groups, allocation procedures, and any blinding or masking techniques employed.
Selection and removal of subjects
This section provides details on how participants will be recruited, screened, and selected for the study. It outlines inclusion and exclusion criteria to ensure that the study population is appropriate for addressing the research objectives.
Treatment of subjects
If the study involves interventions or treatments, this section describes the specifics of how subjects will be treated or managed throughout the study, including dosage, frequency, and administration procedures.
Evaluation of efficacy
Here, the methods for assessing the effectiveness or efficacy of the interventions or treatments are detailed. This includes the choice of outcome measures, assessment tools, and the timing of assessments.
Evaluation of safety
This section outlines the procedures for monitoring and assessing the safety of the participants during the study. It includes the methods for detecting and reporting adverse events, as well as the criteria for determining when safety concerns may require modifications or discontinuation of the study.
In this section, the protocol provides guidance on the collection, documentation, and reporting of adverse events that occur during the study. It includes instructions on how to classify, grade, and manage adverse events to ensure participant safety.
Discontinuation of the trial
If circumstances arise that require the study to be prematurely terminated, this section outlines the criteria and procedures for discontinuing the study, ensuring participant welfare and data integrity.
The statistical considerations section describes the planned analyses, sample size calculations, and statistical methods to be used in data analysis. It ensures that the study is adequately powered to detect meaningful effects and provides a clear plan for data analysis.
Quality control and quality assurance
This section outlines the procedures and measures in place to ensure the quality, integrity, and reliability of the data collected. It includes details on data monitoring, source document verification, and audits.
Ethics and principles
This section describes the steps taken to protect the rights, welfare, and privacy of study participants. It includes information on obtaining informed consent, ethical review board approval, and compliance with relevant ethical guidelines.
Data handling and record keeping
This section outlines the procedures for data collection, management, and analysis. It includes details on data capture, storage, confidentiality, and retention, ensuring compliance with data protection regulations.
Trust Eclevar for the design of your Clinical Trial Protocol
We have a team of research specialists ready to fulfil your specifical clinical needs. Eclevar is a Contract Research Organization with more than 20 years of experience in performing all aspects of a clinical trial and entrance to market of medical devices.
We work alongside your team to complete the necessary documentation in compliance with regulatory agencies requirements. To know more about our services and partnering up for the development of your Clinical Trial Protocol, contact us.