Every clinical research study begins with the preparation of a clinical trial protocol. The protocol is a document that details the study objectives, design, methodology, collection schedules, and statistical analysis of data. Clinical study protocols form the foundation of clinical trials, ensuring the safety of the subjects and the quality of the data collected. Beyond that, protocols provide the reason for conducting the study and the main research questions it will address.
With so many areas to cover, protocols must be formulated carefully to ensure that the trial is operationally feasible and compliant with regulations. Protocols that lack certain details could lead to costly delays in the trial or put patient safety at risk. To ensure that clinical trials fulfil their purpose, here’s a closer look at the best practices to follow when creating study protocols!
1. Cover All Research Activities
Clinical study protocols have a lot to cover. When designing these documents, it’s important to describe in detail all research-related activities, including the study activities that participants will undergo as well as all relevant preclinical data. Each research-related activity should be linked to a research aim and must be consistent with the consent form provided.
Some of the key topics to include in a clinical trial protocol include:
- Objectives or purpose
- Study design
- Selection criteria of subjects
- Safety assessments
- Statistical methods
- Ethical considerations
- Financing and insurance
Students in a clinical research program will explore the scientific approach taken in the development of a research protocol and identify the key elements that must be addressed in a research protocol. In the process, they learn to differentiate between the various types of research designs and discuss the value in the development of research protocols.
2. Get Inputs From the Whole Team
Clinical trial protocols are usually designed by a multidisciplinary team, and all experts have a say in the final document. Beyond those directly involved in the clinical trial, regulatory affairs specialists also contribute to the clinical trial protocol. When writing the protocol, the perspectives of the regulation agencies help to minimize invasive treatments and risks to trial subjects.
The main contributors to a clinical trial protocol include:
- Medical expert
- Pharmacokinetic expert
- Clinical research coordinator
- Project manager
- Medical writer
Those with clinical research training will be ready to make a valuable contribution to the formulation of a sound clinical development plan. In the process, they can ensure that clinical trial data is credible and that the rights, integrity, and confidentiality of trial subjects are protected.
3. Pay Attention to Regulatory Compliance After Clinical Research Training
Professionals working in clinical research know that there are numerous regulations governing the development of drugs, diagnostics, medical devices, and biologics. Part of the purpose of a clinical study protocol is to ensure that proposed trials comply with the guidelines of national or international regulatory agencies. Before writing protocols, it’s crucial to identify where the study will be conducted and the specific requirements that exist in that country or region. That way, you can prevent costly delays and rewrites down the line.
It can also be useful to get an outside review of the protocol from professionals who are not directly involved in the research plan. In the process, they can identify any unclear areas in the document that regulatory agencies may also question. With a clear and detailed approach to developing protocols, you can ensure that clinical trials run efficiently, safely, and effectively.
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