Clinical trials are an important step in the process of finding a cure or solution to diagnose or treat various medical conditions. All medications, vaccines, and therapies the healthcare industry have used in modern medicine are the result of successful clinical trials. But for a clinical trial to pass the approval process, contract research organizations (CROs) must comply with the requirements and submission procedures.
In this article, you’ll learn the most important things about clinical trial submissions.
1. The Required Format
The Clinical Data Interchange Standards Consortium (CDISC), an organization that helps improve medical research through data standardization, sets out the required format for clinical trial submissions. But why do pharmaceutical companies, medical device manufacturers, and other organizations conducting clinical trials need to follow a standard format?
The Study Data Tabulation Model (SDTM) outlines the right clinical trial submission format to ensure consistency in data review and cross-study analysis. The SDTM standardizes the clinical trial data submission process. In that way, each clinical trial follows the same data collection, reporting, and other related processes.
Standardizing the format for clinical trial submissions can help save time and resources. It promotes better data sharing, transparency, and study comparisons and submissions. In addition, clinical trial submissions must meet the Analysis Data Model (ADaM) standards for dataset analysis. You can check here for some dataset examples in ADaM.
2. Foundational Standards Compliance
The data content or foundational standards represent information gathered in clinical trials universally. Following foundational standards enable laboratories and research organizations to remain consistent and reduce the clinical trial submission period at the Food and Drug Administration (FDA) or Pharmaceuticals and Medical Devices Agency (PMDA).
Laboratories and research organizations usually follow a data flow—research planning, data gathering, data tabulation, and data analysis. This data flow is apparent in the following foundational standards:
- Protocol Representation Model (PRM)
Protocols describe the reasons and the manner an organization conducts a clinical study. PRM captures protocol information as data rather than text, creating study outlines and case report forms (CRFs). Moreover, it applies the Unified Modeling Language (UML) and a structure to explain protocol element relationships and make them machine-readable.
- Clinical Data Acquisition Standards Harmonization (CDASH)
CDASH standardizes data collection. It provides recommendations for CRF design with universal common fields. Furthermore, CDASH includes identifiers and describes how clinical researchers must fill out exact field names and additional information in a CRF.
- Study Data Tabulation Model (STDM)
This foundational standard defines how to create tables for clinical trial data. The universal table has rows and columns representing different data and variables, such as names, formats, and codes. SDTM is the most commonly used foundational standard for regulatory submissions.
- Analytical Data Model (ADaM)
This foundational standard reconfigures STDM datasets for each analysis to ensure the correct transfer, replication and tracing of data.
3. Data Exchange Standards Compliance
Clinical trial submissions also must follow data exchange standards. Companies and organizations that discovered a new drug or treatment must know the right format to standardize communication and workflow of clinical trial submissions.
Aside from foundational standards, clinical trials must also comply with data exchange standards. The Operational Data Model (ODM) uses XML format for data exchange to easily convert them into Word, HTML, PDF, and other formats.
This data exchange format applies across the entire healthcare system, including electronic health records (EHR), electronic data capture (EDC), data collection, analysis, archival, and tabulation. The ODM data includes datasets and clinical report forms (CRFs) in an SDTM format.
4. The New EU Clinical Trials Regulation
Clinical trial submissions must comply with the EU clinical trials regulation if the new medicine, treatment, device, or any newly discovered healthcare product or service will be distributed and marketed in EU Member states.
The new EU-CTR (Reg. EU No. 536/2014) aims to harmonize and simplify procedures for clinical trial assessment, supervision, and submission across the EU Member States. It allows sponsors to use a centralized portal to submit a single clinical trial application (CTA).
The new regulation simplifies safety reporting rules. For instance, in a clinical trial with two or more investigational medicinal products (IMPs), only a single annual safety report is necessary for submission to the Clinical Trials Information System (CTIS).
Clinical trial submissions outside the EU must follow the principles of the Clinical Trials Directive provisions if they require marketing authorization in the EU.
Conclusion
Clinical trial submissions involve stringent requirements and procedures to ensure adherence to regulatory and industry standards. This ensures patient safety when taking newly discovered drugs and therapies and using medical devices. Laboratories and contract research organizations must always be up-to-date with the important additions and changes in standards and requirements for successful clinical trial submissions.
