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Electric Charge

Drug failure in the later stages of clinical development and trial terminations due to cardio-toxic off-target effects, together with regulatory requirements, have pushed sponsor companies to invest in early cardiac safety studies. However, managing electrocardiogram (ECG) equipment and supplies can be an expensive part of these Phase 3 tests.

As a result, the centralisation of ECG data, different methods of equipment acquisition – involving core laboratories or third-party equipment rental and management service providers – and adapting to sponsor’s protocols are among cost-effective measures to consider.

Looking into the future, core labs are trying to bring more point-of-care ECG devices into clinical studies, which would facilitate multiple-arm trial management and increase patient adherence – opening the door to dramatic savings and benefits across the industry.

Market Boom

Over the years, the core lab market has seen parallel growth alongside clinical trial outsourcing by Big Pharma. Much of this boom has been due to the popularity in ECG and Thorough QT studies to assess the cardiac safety of new compounds in development; the imaging studies now used as a primary efficacy endpoint; and spirometer-based trials to evaluate pulmonary function.

At the same time, the FDA – through its guidance E14: Clinical evaluation of QT/QTc interval prolongation and pro-arrhythmic potential for non-antiarrhythmic drugs – the EMA, Health Canada, and the Japanese Pharmaceuticals and Medical Devices Agency have encouraged cardiac safety studies for drugs to disprove their cardio-toxic side-effects and prevent trial termination. As such, sponsors are increasingly required to analyse cardiac safety data from trials in order to avert the loss of resources, time and money devoted to clinical R&D (1).

Equipment Costs

Against this background, core laboratories have started to centralise the data of multi-site global clinical trials, integrating electronic data capture systems and telemetry to enable visibility into real-time data, site performance metrics and immediate query resolution. Generally, both Holter ECGs for ambulatory blood pressure monitoring with telemetry, as well as resting ECGs, have been used in trials by core labs.

ECG equipment and the supplies managed in a typical Phase 3 trial contribute about 48-50% of the total project budget, with equipment tracking based on the need of sites, logistics and shipment a challenging part of any global cardiac safety study.

Centralisation has definitely proved to be effective in generating standardised data, avoiding the risk of study repetitions due to inconsistencies which impact the total budget. But it is still in its early days, with only about 30-35% of total ECG studies deploying a centralised method of cardiac safety trials with the large core labs.

The more common decentralised method does not discern the clear needs of the sponsor company and turns the focus away from its core skills. Staffing costs, the number of sites needed and equipment requirements may not be well assessed, making it difficult for the sponsor to gauge the budget (2).

The benefits of centralised ECG studies, on the other hand, include:

  • Savings on additional equipment rental costs
  • A reduction in over-reading costs incurred due to study repetition
  • Better data management 
  • Lower clinical research associate monitoring costs
  • A reduction in site burden

Acquisition Modes

There are different modes of equipment acquisition in a clinical trial, notably specialist core lab providers with an in-house inventory of ECG machines, third-party providers and equipment manufacturers.

Most of the large core labs maintain their own inventory at their global locations or near the sponsor’s sites to ensure faster turnaround time in replacing any faulty machines during the research. Equipment can be shipped to a sponsor-designated central location for later distribution to investigator sites, or transported directly to each site by the core lab. This reduces the shipment costs incurred by the sponsor to a greater extent.

There are two advantages for sponsors in engaging with a large core lab for a multi-site global study:

  • Short lead times to replace equipment at the sites
  • Large core labs buy equipment in big volumes, providing them with concessions that are directly passed on to the sponsor

Mid-size core labs, on the other hand, have their footprint in only a few locations. Currently, most of these labs are located in the US or Europe; if participating in a global, multi-site trial, they ship the equipment long distance from their warehouse to remote sites.

ECG machines used for a study are generally 3-5kgs in weight, which involves considerable transport costs. The rental costs can range from $100-150 per month (3). Therefore, engaging with a mid-size core lab for a global trial concentrated in Asia or Africa, for instance, can add to the total equipment storage, maintenance and shipment costs for the sponsor.

Third-Party Providers

Recent years have seen a growing need for core labs to engage with third-party equipment and ancillaries rental and logistics service providers with clinical trial management capabilities. The emergence of players that concentrate on equipment tracking at sites, shipment, equipment technical support and providing investigator training is on trend.

These service providers support core labs and sponsors in large to small clinical trials. Their job is not over once the equipment is shipped, but involves ongoing management of the equipment throughout the duration of the trial. Such companies typically have a large fleet of machines that are customised according to a client’s needs, as per the study protocol.

Many core labs that are not able to cater to the equipment needs of remote sites engage with a third-party provider. This enables the labs to concentrate on their core competencies. However, a sponsor engaging with a core lab that uses a third party to manage the equipment not only incurs mark-up costs but also has multiple point of contact project managers, which can create confusion when reporting to the sponsors. This can be eradicated with better coordination between the labs and the provider.

Working with a third-party provider that can supply a large fleet of machines may convert into direct savings for the sponsor when the study duration is longer. Suppliers use a flat rate rental price (0 months), but when the sponsor commits to a longer minimum rental period (for example, 6, 12, 18 or even 60 months), prices decrease significantly. ECG rental prices, agreed at the start of a trial, remain the same during the entire study, with no yearly indexing or increase. This visibility of cost savings is absent when using the core lab in-house inventory.

For certain local or regional trials, engaging with a local third-party rental and service provider usually brings better know-how about country-specific issues, saves custom clearance costs, and provides shorter turnaround times in equipment replacement and resolving problems at sites.

Manufacturer Alternative

Meanwhile, many manufacturers have evolved to provide core lab services, and this can be another attractive option. Sponsors that go down this route can save a considerable amount of equipment costs in the overall budget, as the lab is the owner of the ECG equipment being used. This also means the equipment can be customised and data acquisition undertaken in a straightforward way, according to a study protocol, while cutting-edge ECG machines are more likely to be deployed.

However, while considering the size and location of the trial, it is often difficult to prefer a manufacturer over large, specialist core labs. Mostly, manufacturers provide equipment support to the sites through their local distributors for trials happening in Asia, Africa and Latin America.

A Practical Future

Looking to the future, the use of portable and point-of-care testing (POCT) ECG devices for home-based monitoring of patients will bring about a monumental shrink in cardiac safety study costs. Most large core labs are aiming to expand to POCT and real-time data acquisition, in collaboration with wireless device manufacturers, to advance to the next level of assessing cardiac safety of drugs in clinical trials.

Online equipment management tools like web platforms are being developed by equipment rental players for direct ordering of ECG machines and technical support. This saves time involved in resolving the needs of sites in the face of shorter lead times. Down the line, such tools will help to mutualise the inventory between different core labs – increasing the use of equipment and better optimising inventory management.

The procurement options and cost reduction of equipment and supplies in a cardiac safety study budget depend mainly on the sponsor's protocol. There are many ways to impact the overall costs of clinical trials: innovations, the need for effective and accurate data acquisition, and regulations are driving sponsors to find better ways of controlling the budget, especially on the equipment front.

References
1. Weinstein M, Monitoring cardiac safety: Minimizing risk for your next clinical trial, June 2013. Visit: www.bioclinica.com/monitoringcardiac-safety-minimizing-risk-your-next-clinical-trial
2. Furlong A, Centralizing ECGs for efficient accurate cardiac safety assessments in clinical trials, International Pharmaceutical Industry, Winter 2009/2010. Visit: http://ipimediaworld.com/wp-content/uploads/2012/05/pages-from-IPI-volume-2-issue-1-6.pdf
3. Furlong F, Centralising Electrocardiograms, European Pharmaceutical Contractor, May 2010. Visit: www.samedanltd.com/magazine/11/issue/127/article/2618


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Samiya Luthfia Khaleel is Senior Research Analyst – Central and Core Lab Services Procurement at Beroe Inc. Her role involves regular interaction and networking with more than 100 clinical suppliers, and keeping track of market innovations related to the procurement of R&D services. Samiya completed her Master's in Biomedical Sciences at Aston University, conducting her thesis in asthma and chronic obstructive pulmonary disease treatments. She previously worked as a drug discovery scientist and industrial biotech engineer.
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Samiya Luthfia Khaleel
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