Centralize Cardiac Safety to achieve better data quality, integrate, reduce burden and risk, and lower costs to protect patients and compounds

All new pharmaceutical products must go through comprehensive testing to assess their effect on the electrical functions of patients’ cardiac system before being approved for release to the market. As cardiac safety concerns are the number one reason that drugs are refused regulatory approval or withdrawn from the market, the need for reliable, accurate collection and interpretation of ECG and blood pressure data during the clinical trial process is paramount.

Centralizing cardiac safety with ERT in Phase II-IV trials reduces the burden and risks while lowering overall costs by ensuring standardized ECG equipment and algorithms, consistent training, fewer adept readers, cardiologist and electrophysiologist analysis, and real-time digital access. Centralization results in better data quality and increased protection for patients and compounds. And yet, an estimated 50% of studies still use a decentralized approach.

Centralize Cardiac Safety to achieve better data quality, integrate, reduce burden and risk, and lower costs to protect patients and compounds

Centralizing cardiac safety with ERT in Phase II-IV trials reduces the burden and risks while lowering overall costs by ensuring standardized ECG equipment and algorithms, consistent training, fewer adept readers, cardiologist and electrophysiologist analysis, and real-time digital access. Centralization results in better data quality and increased protection for patients and compounds. And yet, an estimated 50% of studies still use a decentralized approach.

The Limitations of Site-Managed Paper ECG Collection

Traditional ECG data gathering methods use a decentralized model where multiple investigator sites use their own local ECG machines and staff to interpret the data collected on paper printouts. However, there are significant downfalls to this approach:

Sites Already Have ECG Machines, Don’t They?

  • Sponsors and CROs must confirm device functionality and details for each site
  • Sites without devices or with devices in poor condition must purchase or rent and set up the new devices, injecting potential study start up delays
  • Paper, leads, and other supplies must be maintained at each site
  • In the event of a machine breakdown, the sponsor, CRO, or site must coordinate maintenance and repair

Different Site Machines & Paper

  • Different machine types at different sites means that interval duration measurement (IDM) data from ECGs is often inconsistent, as each device type uses a unique algorithm, in particular for QTc results The measurement of algorithms in ECG tracings with abnormal ST-T morphology are notoriously inaccurate
  • Old or poorly constructed equipment can introduce errors and inconsistencies. Has the equipment been tested for full functionality or programmed with the correct demography capture, ECG format, IDM or even paper type/speed to support the study protocol?
  • Transcription errors can create further inconsistencies in ECG results, and the digital version of the data that may be needed later for analysis of submission to regulatory bodies is not available
  • XML submission to FDA’s ECG Warehouse can be a very laborious and costly process if the data is not digitized as it is captured

Not All Site Analysis is Reliable or Free

  • The overread of ECG output is not consistently analyzed across investigational sites in a decentralized model and varies greatly by site
  • The vast majority of sites do not have a cardiologist – the investigator is a physician but in some other specialty
  • Even if available, cardiologists at sites are often experienced with healthcare patient ECG analysis and are not familiar with or capable of high precision QT measurements
  • ECG morphology interpretations are especially challenging in utilizing ECG device output, and there could be false positives
  • ECG machine messages can add to the difficulty, categorizing issues as “possible” or “probable” – which may lead to missed adverse events by the site investigator and inconsistent reporting of ECG abnormalities
  • Additional fees can be required for professional cardiologist overreads on a site-by-site basis, which include a technical fee for the ECG acquisition and a professional fee for evaluation of the ECG, ranging from $75-250 per ECG alone

Decentralization is not the cost-effective option that most perceive it to be, introducing unforeseen challenges, burdens, budget expansion, and delays. The delay in collecting and processing paper records could delay the overall process and cost sponsors significant dollars in each day a clinical trial is extended, either during the study in making decisions as well as locking the database at the end of a trial. Most importantly, the lack of consistency and quality of data from this approach can undermine a study’s legitimacy, hamper asset protection, possibly cause a compound to not be approved, or introduce future patient safety issues and market withdrawal.

The Value in Centralizing Your Phase II-IV Cardiac Safety Studies

As cardiac safety is the leading reason for withdrawal and potential delays in the drug approval process, sponsors want assurance of no cardiac signals. Regulatory guidance (ICH E14, 2005) recommends but does not go so far as to mandate centralization, standard, validated equipment, fewer expert readers, and a digital submission database. For investigation sites, this is difficult to deliver on for the reasons explored in a decentralized model. For sponsors and CROs, specialized cardiac safety expertise is sought from ERT to reduce complexity, contain risk and costs, deliver efficiencies, and ensure fast, reliable data. A centralized approach to cardiac safety offers many benefits in scientific outcomes, operational effectiveness, overall cost savings, and asset protection (learn more).

The Value in Centralizing Your Phase II-IV Cardiac Safety Studies

Regulatory guidance (ICH E14, 2005) recommends but does not go so far as to mandate centralization, standard, validated equipment, fewer expert readers, and a digital submission database. For investigation sites, this is difficult to deliver on for the reasons explored in a decentralized model. For sponsors and CROs, specialized cardiac safety expertise is sought from ERT to reduce complexity, contain risk and costs, deliver efficiencies, and ensure fast, reliable data. A centralized approach to cardiac safety offers many benefits in scientific outcomes, operational effectiveness, overall cost savings, and asset protection (learn more).

Device Recommendations for Phase II-IV Trials

Enroll more patients with precise ECG measurement
What impact do inaccurate site machine ECGs have on your study?

Price Assurance in Your Centralized Study

ERT offers a program to control budgets and streamline processes. With Cardiac Safety Price Assurance, we provide value pricing with predictable cost protection for reduced risk of budget overruns focused on known costs and reduced burden for a small piece of overall study costs. We also simplify the process to relieve burden on your sponsor or CRO study management teams, with invoicing simplicity to reduce change orders, eliminating monthly or end of study reconciliations and making your vendor management direct and easy.

Digital Collection and Storage for Future Cardiac Safety Analysis

For sponsors and CROs that want to preserve future options, we offer a service to digitally collect, clean, and store ECGs centrally instead of analyzing them. This provides the benefit of having ERT deliver standardized ECG devices to all sites, cleaning the patient demography, and storing the ECGs in the required FDA formatting in the event analysis was ever needed.

Retrospective Paper and Digital Services

If your team is looking to “rescue” studies for analysis, use our centralized, high-resolution ECG processing for your paper or past-collected digital ECGs. We solve data-variability problems from inconsistent ECG collection and evaluation methods common to paper-based studies by digitizing the recording, transmitting, processing, and reporting on the ECGs in your trial.

Price Assurance in Your Centralized Study

With Cardiac Safety Price Assurance, we provide value pricing with predictable cost protection for reduced risk of budget overruns focused on known costs and reduced burden for a small piece of overall study costs. We also simplify the process to relieve burden on your sponsor or CRO study management teams, with invoicing simplicity to reduce change orders, eliminating monthly or end of study reconciliations and making your vendor management direct and easy.

Digital Collection and Storage for Future Cardiac Safety Analysis

For sponsors and CROs that want to preserve future options, we offer a service to digitally collect, clean, and store ECGs centrally instead of analyzing them. This provides the benefit of having ERT deliver standardized ECG devices to all sites, cleaning the patient demography, and storing the ECGs in the required FDA formatting in the event analysis was ever needed.

Retrospective Paper and Digital Services

We solve data-variability problems from inconsistent ECG collection and evaluation methods common to paper-based studies by digitizing the recording, transmitting, processing, and reporting on the ECGs in your trial.