CLINICAL TRIAL DESIGN: HOW TO CREATE A SUCCESSFUL STUDY PROTOCOL
Introduction
A protocol is defined as a document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and the integrity of the data collected. It describes the background, rationality, design, methodology, statistical considerations, and organization of a clinical research project. A well-designed study relies predominantly on a thoroughly considered, well-structured and complete protocol. The protocol must be designed only after the NDA that is new drug application is approved by FDA that is food and drug application. Implementation of protocol must be done only after the approval of IRB/IEC/ERB (Institutional Ethics Committee/ Independent Ethics Committee/ Ethical Review Board)
Components of protocol
The components of the protocol can vary depending upon the complexity of the clinical trial. The basic components are as follows:
General information: this includes title, identifying number of the protocol including date. Name, title, address and contact numbers of sponsor’s, monitors, investigators and any other technical department or medical department involved in the study must be mentioned.
Background: this describes any relevant information that led scientists to ask their research questions. This could include on a particular disease, information of a drug on particular population etc.
Objectives and justification: this section includes aims and objectives of the study. Name and description of the investigational product along with its potential risk and benefits, if known to humans. A statement that the trial will be conducted in accordance with GCP guidelines.
Ethical consideration: general ethics related to study must be mentioned. Description of how an informed consent from will be obtained from the volunteers will be mentioned.
Study design: the scientific integrity of the study and the credibility of the data from the study depends upon the study design. Description of the study type, treatments, packaging and labelling manner, duration of the study, date of study initiation etc.
Inclusion, exclusion and withdrawal of subjects: specifications of the subjects to included and excluded in the study with regard to the trial will be mentioned. A statement saying “subjects are free to withdraw from the trial whenever they want to” must also be mentioned.
Handling of the product: this includes the measures to be implemented to ensure the safety handling and storage of the investigational product and the product label must contain “FOR CLINICAL STUDIES ONLY” along with the study code, name, contact number of investigator, institute name and subject’s identification code.
Assessment of efficacy: it describes the specifications of the effect parameters to be used, time and periodicity of effect recording. Description of how effects are measured and recorded that is description of special analytical analysis and tests to be carried out.
Assessment of safety: this includes specifications of safety parameters. Procedures for monitoring adverse drug reactions / adverse events / inter - current illness. Type and duration of the follow – up subjects post adverse events must also be mentioned.
Statistics: it includes the description of statistical methods to be employed, including the timing of any planned interim analysis, procedures for managing missing data, unused data and unauthentic data, procedures to report any deviations from the original statistical plan etc.
Data handling and management: a statement should be clearly made in protocol that the investigator / institute will permit study – related monitoring, audits, ethics committee review and regulatory inspections providing direct access to source data / documents. A copy of the CRF should be included in the protocol. Besides, procedures for handling protocol and processing records of effects and adverse events, procedures for the keeping of records of patient lists to facilitate easy identification of individual subjects.
Quality control and quality assurance: this includes a meticulous and specified plan for the various steps and procedures for the purpose of controlling and monitoring the study most effectively. Along with quality control of methods and evaluation procedures and considers confidentiality problems, if any arise.
Finance and insurance: this includes all the financial aspects of conducting reporting a study may be arranged and budget made out. Information about all the economic support sources must also be made available (eg: foundations, private or public funds etc.) it should also state how expenditures should be distributed (eg: payment to subjects, payments for special tests, technical assistance, purchase of apparatus). Study subjects should be satisfactorily insured against any injury caused by the study.
Publication policy: if a publication policy is not addressed in a separate agreement, it should be described in the protocol.
Evaluation: a specified account for how the response is to be evaluate, methods of computation and calculation of effects and description of how to deal with and report subjects withdrew from / dropped out of the study must also be mentioned.
Significance of clinical trial protocol
It demonstrates the guidelines for conducting the trials.
It illustrates what will be made in the study by explaining part of it and how it is carried out.
It describes the eligibility of the participants, the length of the study, the medications and the related tests.
It provides a medium and set rules to establish communication between different devices for the exchange of the other services.
It provides a precise study plan.
The preparation of protocol is the most crucial step in clinical trials. It is the foundation block for the conduction of successful clinical trials. Adherence of clinical trials with the protocols aids to minimize errors. It even helps in the conduction clinical trials in a categorized manner. If the protocol is meanly prepared and not adhered to clinical trials then it is unlikely, that the project will yield the information that may be accurate which is a failure of the clinical trial therefore, it is very essential to prepare a clinical trial protocol with at most accuracy in accordance with the investigational product.
References
J Clin Diagn Res. 2016 Nov; 10(11): ZE10–ZE13. Published online 2016 Nov 1. doi: 10.7860/JCDR/2016/21426.8865
trials.lilly.com/en-US/blog/what-is-protocol-clinical-trials
blog.trialspark.com/whats-a-clinical-trial-protocol/
Student Name: Simhavalli.Godavarthi
Student ID: 079/042023
Qualification: Pharm.D
e-Mail ID: godavarthi555@gmail.com
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