Menu Close

ACDM News Item

Latest News from ACDM

Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO)

September 23, 2024

This article has been submitted by Leeni Joshua of ICON plc

Introduction:

Digital Data Flow (DDF) provides a mechanism to modernise clinical trials, facilitating a digital workflow that enables the automated generation of study elements and configuration of study systems to support the execution of clinical trials.

DDF initiative supports the creation of a digitised protocol that can be used by the downstream systems involved in the execution of the clinical trial. As a result, this enhances the flow of clinical information by improving its quality and relevance, while ensuring traceability across systems. Consequently, it leads to enhanced and optimised processes throughout the entire life cycle of the clinical trial.

The Role of ePRO in Clinical Research:

Patient-Reported Outcome (PRO) measures play a crucial role in clinical research, providing information that formsthe basis for decisions related to study design. The increasing adoption of electronic Patient-Reported Outcomes (ePRO) has transformed the landscape of data collection in clinical research, enabling traceability, automated dataflow and interoperability between systems.

This article explores the integration of DDF with both upstream and downstream processes in the context of ePRO, highlighting the challenges faced and the advantages gained in leveraging DDF as a foundation for data exchange, leading to greater compatibility among systems, flexibility to sponsors, and improved clinical trial efficiencies.

Interconnected Processes with DDF:

The upstream and downstream processes in DDF are interconnected using a common, industry-standard StudyDefinition Repository (SDR). DDF uses these standards to digitise the information related to major protocol components such as study information, study objectives, endpoints, inclusion/exclusion criteria, schedule of activities, and more.

By establishing a lineage between the Schedule of Activities, visit information, and data definition in a Metadata Repository, it becomes possible to automate the study build process in EDC and generate Data Transfer Specifications for ePRO.

Integration of DDF with these processes encounters challenges such as standardising diverse data inputs. For example, instruments like the Patient Global Impressions scale or the Pain intensity scale, which are in the public domain, do not have a single standardized version. This is due to the inclusion of the specific disease/condition, signs related to the disease/condition, function, and/or functional impact of interest within the wording of the global item; Additionally, the response options on these instruments vary and have not yet been standardised.

Questions also emerge in ensuring compliance with existing regulatory standards such as the CDISC controlled terminology. The test concepts and codelists assigned to questionnaire items in the SDTM terminology and SDTMIG supplements are typically derived from traditional paper versions. However, Issues may arise when items from the ePRO system are submitted differently due to programmatically derived or concatenated data. These issues can result in downstream errors, specifically with Pinnacle 21 (P21) validation rules.

Nonetheless, since DDF is agile and vendor agnostic, any product or platform capable of consuming data in a CDISC standard format can be easily integrated into the digital data flow and accommodate any change in standards, minimising the impact on ongoing trials and reduce the cost in change management.

Transformative Impact of DDF Integration:

Most PROs are standardized tests that is of Classical Test Theory (CTT), which are composed of a fixed number of items – that is, a question and its associated response scale and results in summed scores and requires respondents to complete the entire test for comparability. While they may be simple to administer, it may lead to increased burden due to the quantity of questions required to be answered, especially when the subjects are asked to complete multiple PROs together. Computerized adaptive tests (CATs) instead, use a variable number of items selected from a larger set of items, also known as an item bank. The item bank typically provides information across the full range of severities of a particular concept of interest, for example, physical function. Each subsequent item is selected based upon the responses provided to all the previous items. In this way, the response to each subsequent item becomes more focused and precise, leading to a higher level of confidence in the final estimate or score of the concept being evaluated. When sufficient confidence in the reliability of the estimate is achieved, the test can stop, and no further questions are required.

DDF opens doors to create end-to-end lineage and automated information flow between the clinical protocol and the downstream ePRO systems, thereby using advanced analytics such as IRT in CAT to enhance the optimisation of study design and refining analysis populations, scheduling of activities, patient engagement and operational efficiencies.

Addressing Technical and User Challenges:

The implementation of electronic clinical systems can be challenging in general, and ePRO systems are particularly susceptible to difficulties. In addition to facing typical technical issues, ePRO is also used by potentially thousands of study participants, many of whom may have limited technical understanding. Therefore, to ensure that all trial participants are included, the implementation of ePRO systems may need to be done in parallel with existing paper PRO collection systems.

Conclusion:

In summary, the integration of DDF with upstream and downstream processes involving ePRO presents challenges,particularly those related to regulatory compliance, technology barriers and costs of change management. However, it is important to consider these concerns within the context of early adopters’ success and the increasing interest and support from the FDA.

The effective integration of DDF not only improves data quality and integrity but also accelerates processes, empowers decision- makers, and contributes to advancements in patient-centric clinical research.

Other News

Regulatory Considerations DMEG Update – September 2024 September 24, 2024

Guidance for Industry: Conducting Clinical Trials With Decentralized Elements September 23, 2024

Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO) September 23, 2024

Welcome FGK Clinical Research as a new corporate member April 23, 2024

Welcome LINK Medical as a new corporate member April 5, 2024

Welcome Zilla Clinicals as a new corporate member March 26, 2024

Challenge ChatGPT: CDMs vs AI March 22, 2024

Welcome Boehringer Ingelheim as a new corporate member February 6, 2024

Welcome Datacapt as a new corporate member January 12, 2024

Welcome Climedo as a new corporate member December 15, 2023

EMA Management Board: Highlights of October 2023 meeting November 27, 2023

Clinical Trials for Medicines – New Notification Scheme November 27, 2023

Welcome Mednet as a new corporate member November 22, 2023

Welcome Allucent as a new corporate member November 14, 2023

Welcome KCR as a new corporate member October 20, 2023

Welcome Debiopharm as a new corporate member October 3, 2023

European Medicine’s Agency – Reflection paper on the use of artificial intelligence in the lifecycle of medicines September 25, 2023

ACT EU PA04 – Multi-stakeholder Workshop on ICH E6 R3 September 25, 2023

HMA/EMA joint Big Data Steering Group: Big Data Workplan 2023-2025 September 25, 2023

Welcome Instem as a new corporate member August 16, 2023

ICH GCP E6 Revision 3 is here. Regulatory Considerations Expert Group to review. June 19, 2023

Regulatory Considerations Expert Group reviews draft FDA Guidance June 19, 2023

Welcome Algorics as a new corporate member May 18, 2023

Guideline on computerised systems and electronic data in clinical trials April 25, 2023

FDA Guidance for Industry  April 25, 2023

New MHRA Guidance April 25, 2023

Consultation response on legislative proposals for clinical trials April 25, 2023

Welcome IROS – Insights Research Organization & Solutions as a new corporate member February 9, 2023

Recommendation paper on decentralised elements in clinical trials December 19, 2022

Welcome George Clinical as a new corporate member December 16, 2022

Welcome Clinion as a new corporate member December 7, 2022

Welcome ClinoSol Research as a new corporate member October 18, 2022

CTU DMEG Update September 29, 2022

ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability” April 5, 2022

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management April 5, 2022

Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials January 26, 2022

Signant Health are ACDM22 Photography sponsors November 19, 2021

Anju Software is exhibiting at ACDM22 October 29, 2021

SGS Health Science to sponsor ACDM Awards for the second year running October 1, 2021

ACDM Interactive September 7, 2021

nuvoteQ to be a Premier Sponsor of ACDM22 August 23, 2021

IQVIA to be a Premier Sponsor of ACDM22 August 19, 2021

Anju Software to be a Premier Sponsor of ACDM22 August 15, 2021

CORE to be Premier and Interactive Sponsor for ACDM22 August 12, 2021

eClinical Solutions to be Premier and Communications & Social Media Sponsor for ACDM22 August 5, 2021

ACDM Annual General Meeting  July 29, 2021

Phastar announced as Premier & Conference Dinner Sponsor of ACDM22 July 1, 2021

New online training course – Risk Based Monitoring May 4, 2020

Building data management success in Sponsor/CRO relationships online webinar 30th April April 22, 2020

ACDM21 – Location announced April 8, 2020

ACDM Hot Topic Discussion – Implications of COVID-19 on clinical data management activities globally March 31, 2020

ACDM eDigital DMEG publishes its GDPR Q&A report March 30, 2020

ICON to be Premier & Award Sponsors for ACDM20 December 2, 2019

New Online Learning Course – Understanding Laboratory Data November 19, 2019

Nominations now open for ACDM Awards 2020 October 14, 2019

Phastar announced as Networking Sponsor for ACDM20 July 9, 2019

ACDM20 Dates & Venue July 1, 2019

Launch of Online Training from ACDM March 24, 2019

ACDM 2019 Awards Finalists February 22, 2019

Castor EDC to Sponsor ACDM19 January 15, 2019

Danone Nutricia Research to Sponsor ACDM19 November 26, 2018

ACDM19 Conference Programme November 21, 2018

Record Number of Abstracts Submitted for ACDM19 October 1, 2018

Phastar Sponsor ACDM19 September 3, 2018

Launch of Annual ACDM Awards September 1, 2018