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Clinical Data Management

Clinical Data Management: What Are The Key Challenges And How To Navigate Them?

Rajesh Swamy Pothula

In the recent past, clinical research sites would use paper-based systems to record patient information. Today, new technologies are being developed to help streamline the process, such as Clinical Data Management Systems. These systems are designed to help improve the quality and efficiency of clinical research data collection by providing electronic systems to record, manage and archive data.

What challenges do clinical data management systems currently face?

One of the biggest challenges clinical data management faces is the sheer amount of data that needs to be processed. With more and more patient data becoming available, it can be difficult for CDM systems to keep up. In addition, many CDM systems are not user-friendly or interactive, making it difficult for users to get the most out of them.

Clinical data management is also challenged by:

Clinical Trial Complexity

The modern clinical trial design requires real-time data modelling and simulation to provide reliable information that supports faster decision making and reduces development time, costs, and late-stage research failures. Nowadays, many clinical trials are considered adaptive, meaning that they can change as the trial progresses and that incoming data is used to determine next steps. In such a scenario, if a patient does not react to a drug, it may be decided to change the drug or dosage.

Some therapeutic areas and scenarios like immuno-oncology, multi-arm trials also add new levels of complexity to clinical trials.

The future of clinical data management lies in the ability to adapt to these changes and needs. In order to be truly effective, a CDM system must be able to handle large amounts of data, be user-friendly and utilise artificial intelligence to automate tedious manual tasks.

Mid Study Changes

Clinical Data Management is a complex process. It involves multiple stakeholders, from investigators to sponsors and CROs. This can make CDM challenging, especially when it comes to the mid-study changes (MSCs).

Mid-study changes are amendments to protocols or study data management plans (SDMPs).

Mid-study changes can be due to any or all of these reasons:

  • Change in inclusion/exclusion criteria
  • Change in dosage/frequency of drug administration
  • Exclusion/inclusion of new patient subpopulations
  • Inclusion/exclusion of new therapeutic agents/devices
  • Change in primary outcome measure (PRO) or secondary outcome measures (SO).

A study by Tufts says that approximately 70% of its respondents say unplanned mid-study changes are the primary reason for the trial delay. Planned changes can be even more challenging as they require extensive planning before going live so that they don’t interfere with ongoing trials or other projects.

The changes needed during the study are a major challenge for CDM. Planned and unplanned mid-study changes are significant reasons for the trial delays. So a system that supports faster mid-study changes and which is very easy to use and faster to go live is the need of the hour.
The CDM system should be able to handle all the required changes in a single place instead of going through multiple systems to make changes.

Is The Role of Clinical Data Managers Changing?

Clinical data management has come a long way in the last few decades. What once started out as a small department within a clinical research organisation has now become a critical and highly specialised function. In the past, clinical data managers were responsible for data entry and cleaning.

In the late 90s, the role of the CDM began to change as electronic data capture (EDC) became more prevalent. The CDM was responsible for configuring the EDC system and creating and managing data queries.

Today, clinical data managers are responsible for developing and implementing data management plans, ensuring data accuracy and completeness, and ensuring data security.

What is the future of clinical data management?

The future of clinical data management depends upon systems and regulations. There must be clear policies regarding ownership of patient information and data sharing among organisations involved in a trial. There must also be standardisation of formats to store patient information and documents related to trials. This will help ensure that there is no ambiguity about who owns what kind of information or document at any time.

The future of clinical data management is likely to be more automated, with greater use of artificial intelligence and machine learning to sift through data to identify patterns and trends from sites, patients, and trials, which will help accelerate the drug development process. These new technologies will lead to a better understanding of diseases and improved patient outcomes to further improve the accuracy and completeness of data.

CDM roles are already evolving to require expertise in data science and analytics in order to make sense of the large and growing volumes of data being collected. In the future, CDMs may also need to be able to work with artificial intelligence and machine learning tools to help automate data management tasks and improve data quality.

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