CDISC: Towards successful clinical trials!

In clinical research, data management and analysis are of fundamental importance in guaranteeing the validity and reliability of results.

With the increasing complexity of clinical trials, and the need for greater collaboration between the various actors involved in clinical research, the standardization of data formats has become essential. In response, the Clinical Data Interchange Standards Consortium (CDISC) created reference guidelines to assist with the standardization of clinical data.

This article explores the reasons why CDISC has become indispensable for clinical trials, highlighting its benefits and impact on the efficiency of medical research.

1.        What is CDISC?

Definition and history of CDISC

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization founded in 1997 to promote and develop standards for the exchange of clinical data.

CDISC standards were created in response to the growing need to harmonize data formats and facilitate communication between different actors, such as clinical trial sponsors and regulatory bodies.

The different standards proposed by CDISC

Since its creation, CDISC has established data models that enable data to be collected, stored, transmitted and submitted in a structured way.

Adopted by the US Food & Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), some standards have become mandatory for the organization (Study Data Tabulation Model or SDTM) and analysis (Analysis Data Model or ADaM) of clinical data.

It should be noted that CDISC does not simply propose standards, but an evolving framework designed to meet the growing needs of clinical research. These standards cover all stages of a clinical study, from start to finish.

2.        What are the benefits of CDISC for the conduct of clinical trials?

By providing a standardized framework, CDISC offers benefits such as improved processes among stakeholders, optimized audits and regulatory approvals. It likewise reduces risks and costs, while conversely enhancing quality and strengthening customer trust.

i.                             Improvement of processes

Collaboration among stakeholders (sponsors, regulators, etc.)

CDISC plays an important role in facilitating collaboration among various stakeholders in the clinical research sector, including sponsors, regulatory authorities, researchers, CROs, etc. By establishing standards that ensure clear and harmonized data, CDISC enables smooth and effective communication between these actors.

This collaborative approach not only enhances transparency and trust among the involved parties but also contributes to the overall efficiency of health product development, such as medicines, by enabling faster and more informed decision-making.

By demonstrating a commitment to rigorous data collection, exchange and analysis practices, companies can establish a reputation for reliability, trust and transparency. This can be particularly important when seeking funding or partnerships, as investors are more likely to support projects that demonstrate a solid methodological foundation.

In short, CDISC is an essential catalyst for more integrated and interconnected clinical research.

Faster review and audit processes

Review and audit processes are considerably accelerated when data are rendered CDISC-compliant from the beginning of a clinical research project.

Auditors and regulatory reviewers can more easily grasp the data because the structure of the data remains identical between each study and each sponsor. This allows them to easily navigate the data sets and understand the methodology used, thus reducing the time required to familiarize themselves with the data and study, and ultimately reducing the time spent reviewing the data.

This allows teams to concentrate on analyzing results rather than preparing documents for audits, thereby increasing overall project efficiency.

Acceleration of regulatory approval processes

The application of CDISC standards also has a significant impact on speeding up regulatory approval processes for clinical trials.

The FDA and PMDA have made the integration of CDISC standards mandatory for regulatory submissions. This makes it more important than ever for manufacturers to understand and master these standards.

By providing uniform standards for the presentation of clinical data, CDISC facilitates the submission of dossiers to regulatory agencies. These standards enable sponsors to structure their data consistently and in line with regulatory requirements, reducing the risk of returns or requests for clarification from agencies.

By streamlining communication between researchers and regulators, CDISC helps to reduce review times and promote faster decision-making on the approval of new treatments.

ii.        Reduced risk, increased quality

Improved data quality.

Using CDISC standards ensures better integration and interpretation of information from various sources. It also reduces data errors and inconsistencies.

With the help of standardized formats such as SDTM and ADaM, scientists can ensure that data is presented in a clear and consistent way, significantly improving the transparency and reproducibility of results.

Reduced data management costs and delays.

Even if the implementation of CDISC formats has an initial cost (staff training, modifications of existing collection standards, mapping for data transformation), the impact on reducing subsequent costs and delays linked to data management remains considerable.

By using harmonized standards right from the collection stage, through to data processing and analysis, CDISC streamlines data management processes. This translates into fewer errors and inconsistencies, reducing the time needed for data cleansing and validation.

Furthermore, the use of standardized and therefore compatible formats facilitates the integration of data from different sources and systems, speeding up the overall workflow and improving operational efficiency.

Better risk management: a reassuring aspect

Finally, the integration of CDISC standards enables better risk management throughout the clinical trial. With standardized processes and well-structured data, teams can more quickly identify potential problems, be they data errors or non-conformities.

Proactive risk management means that corrective measures can be put in place quickly, minimizing the impact on the project and ensuring that the trial stays on track.

3.        The main challenges encountered when adopting CDISC

The adoption of CDISC standards in clinical trials presents several significant challenges.

Firstly, the transition to a standardized format often requires a complete overhaul of collection processes (modification of questionnaires). In addition, lack of understanding and familiarity with CDISC standards among research teams can lead to errors in implementation, compromising data quality. Resistance to change among teams and stakeholders can also hinder the effective implementation of CDISC standards. To overcome these challenges, appropriate training, coaching and communication strategies are essential.

Training on this evolving format is therefore essential. To understand the stakes and impact of CDISC on their studies, companies need to invest in ongoing training for their teams and adopt appropriate technological tools. Collaborating with experts in the field from the earliest phases of clinical development is therefore a key strategy. The “path” to CDISC standardization requires some effort, but in the long term, it will lead to significant time saving and optimization of resources.

Conclusion

The adoption of CDISC in clinical trials is not just a trend, but a necessary evolution in the medical research landscape.

Compliance with CDISC standards is essential for submissions, particularly to the FDA; compliance with these standards will avoid costly delays and optimize the chances of project approval.

The integration of CDISC standards helps to strengthen stakeholder confidence in clinical trial results. These standardized formats not only facilitate data collection and analysis, but also improve transparency and collaboration between the various players in the industry. Implementing CDISC standards not only improves efficiency, compliance and integrity, but also, and above all, enhances the quality of results.

It is therefore imperative for researchers and sponsors of clinical trials to familiarize themselves with these standards, in order to remain competitive and contribute to the advancement of medical knowledge. In short, CDISC is an essential tool for ensuring the rigor and integrity of the clinical trials of tomorrow.

To find out more about CDISC standards, please visit the official CDISC website at www.cdisc.org or contact our certified training Center TREE for information on our Data Management training modules

Need help?

Our CRO experts can help you with:

• Drafting the CRF in CDASH format
• Mapping and table programming in SDTM format
• Statistical analysis in ADaM format
• Overall support for the implementation and conduct of your study
• Preparation of FDA submission package (tables in xpt format, Define.xml and cSDRG)
• Dedicated expertise via our hotline for specific questions requiring a rapid response

Contact us at onedt@efor-group.com.