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International Clinical Trials

Kitted Out?

In the clinical research sector in the 1990s, equipping investigator sites was a pretty wild story. Project managers, both at sponsors and contract research organisations (CROs), would undertake this at a very late stage of study design, and it was often addressed in a poorly considered and inconsistent way.

Past and Present

Back then, it was about contacting the sites in the run-up to the clinical trial, prior to the site opening, to identify who was lacking what in order to conduct the trial. It was about sourcing equipment in an emergency mode and getting it delivered to sites. There were constant unplanned costs and boundaries to overcome.

Today, the picture has changed markedly. Particularly over the last 10 years, equipment supply to investigator sites has become more critical for a number of reasons, including:

● Authorities now ask for a growing number of tests on patients, requiring a larger range of on-site patient monitoring equipment

● Sponsors and authorities require equipment to be standardised for all sites involved in a trial to strengthen data consistency. This leads to equipping all sites, rather than only those missing a required piece of equipment

● Increased quality assurance requirements have raised the need for traceability of all equipment supplied on a trial, with a full audit trail of equipment management (period-correct certificates of calibration, temperature loggers, storage conditions tracking, and so on)

● Anti-bribery laws in a growing number of countries have made it no longer possible to leave the equipment on-site after a trial. Equipment now needs to be on-site for the trial duration only and recalled once the study is completed

Furthermore, given the higher equipment volumes and growing logistics needs, the information around equipment management has become an issue in its own right. Tracking tools to manage equipment, from the big picture down to the smallest details, are becoming increasingly necessary, to avoid the well-known multiplication of spreadsheets and alternative versions among the project team managing the trial.

Equipment Needs

The question of equipment needs should be taken into account at an early stage of study design. It should be considered a key issue in the design as it will have a significant impact on study deployment, progress and cost.

Time should be taken to specify the needs and assess costs precisely. For instance, a cooled centrifuge is about five times the cost of an ambient one, and the type of tube used to collect blood samples has an impact on the centrifuge model that will be needed. In addition, will the monitoring of blood pressure involve a simple sphygmomanometer, an ambulatory blood pressure monitor, or a scope? If this is not clear, differing understandings of monitoring requirements could lead to a five-fold budget increase.

Centralised Thinking

A classic reflex when providing specific equipment for trials taking place in multiple countries is to rely on a manufacturer’s global network to manage maintenance locally. This has often proven to be a wrong choice: local distributors are not keen on maintaining devices that they have not sold; they are not used to the specific requirements of clinical research; and they will not be able to provide a global tracking of interventions for audit purposes. It is recommended that equipment is managed centrally with a partner that has relevant capacity and a suitable tracking system.

Logistics and Customs

In 2013, we take it for granted that a parcel can be delivered from London to Beijing in 24 hours. But, while this might be the case for small, low-value parcels, it is a different story with larger items of medical equipment. Transporting a medical freezer, for instance, will entail managing the customs process due to its value, handling regulatory issues relating to the compliance of the cooling liquid, and using a specialist delivery courier due to weight – all in all, this may take around 10 days.

Taking a security margin to be on the safe side in terms of delay is a good option. It can even reduce the delivery cost, should a low-speed courier be used.

Over­ Filling Supplies

When a site runs out of supplies, such as electrocardiogram electrodes, memory cards or needles, the risk of patient dropout greatly increases. This leads to shipping urgent resupplies on a global scale, resulting in expenses which largely exceed the costs of the supplies themselves.

Most supplies have relatively low value and a limited date of use (LDU) that is between 18 and 24 months ahead. It is advisable to overfill initial site kit with a great number of supplies, but also to track the LDU centrally to renew supplies accordingly.

Flexible Contract

When needing equipment for a trial, project managers often balance equipment purchase and rental. Purchasing equipment is not flexible or capital intensive, and manufacturers will not bring the requisite level of technical support and logistics management that is expected: their job is to build equipment.

However, this does not mean that renting is always the best bet. A rental contract has to fit with the needs of the trial. Questions to consider include:

● Can the rental be stopped at any time if the trial ends prematurely?

● Does it involve a deposit?

● Are there any hidden costs?

● Is there the required level of technical support?

● What is the cost of replacing a broken unit?

Rental has to be 100 per cent flexible, because it is impossible to predict how a trial will run. Make sure you are not locked into a rigid contract.

Equipment Tracking

When, for example, a project manager needs to manage two pieces of equipment for 100 sites, this equates to 200 units, and each comes with a shipping date, a return date, calibration certificate, shipping cost, study configuration, LDU for supplies, and so on. This is a substantial amount of data, and Microsoft Excel spreadsheets are usually not the best tool.

Rental companies now offer tracking tools that make it possible to monitor equipment deployment live and provide data in various formats, so it can be archived at the end of the study for quality assurance purposes. These systems are often free. It is recommended that they be set up from the start and that all relevant parties, including the investigator, are given access so they can track shipments and reorder supplies.

Site Training

It should not be assumed that investigators know how to use equipment. Training is key to the proper use of equipment and has heavy mid-term consequences in terms of technical support volume, future queries and time needed for trouble-shooting. Standard operating procedures for training, with a precise ticklist of topics to be reviewed, are invaluable, as is a signed training acknowledgement from the site that includes all the relevant topics. The usual telephone training can be supported with videos showing the do’s and the don’ts for each device.

Get the Most from Partners

Aim to get the most from an equipment partner, whether they are a CRO, central lab or rental company. Customers should be demanding and precise. Ask for more than the equipment itself, and embrace all other issues related to equipment: flexibility to add or close sites; the option of stopping the trial at will; the need for special features; and so on. Ask also for precise answers on how technical support is managed; inquire about all the hidden costs and unplanned scenarios; and seek a comprehensive and live tracking tool with archiving possibilities.


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Pierre Malingrey graduated from HEC Paris school of management in 1997. He developed a leading electrocardiography laboratory between 2000 and 2010, with particular focus on equipment deployment and logistics, managing equipment for more than 500 trials over this period. In 2010, Pierre founded Quipment, an equipment rental company with global reach that develops new tools to manage equipment for clinical trials.
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