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International Clinical Trials

Inside Story

The provision of home trial support services raises many questions, from how to train nurses through to how to transfer information to data systems, and everything in-between. However, the fundamental theme behind every question is the quest for reassurance that those who manage these services know what they are doing.

Home trial support services replace a number of the on-site visits required during a clinical trial with nurse visits to the patient’s own home. These services aim to speed up trials, while ensuring the delivery of customer objectives. In many cases, up to 50 per cent of trial visits can be performed in the home, which significantly reduces the burden on the patient.

If you offer to see a patient in their own home in a trial, they are more likely to consent to participate and to remain involved until the end. Medical Research Network (MRN) has seen recruitment rates increase by at least 50 per cent when utilising home trials and repeatedly reports retention rates no lower than 96 per cent.

When it comes to the nuts and bolts of a home service, it is important to understand:
  • The processes behind the service
  • How it works – for example, suppliers, technology, etc
  • Who does it – team qualifications, experience and training
  • How well it is done – quality management
Quality Management

Quality management is the central issue as it encompasses the number one demand – patient safety. From a safety perspective, home trial support organisations tend to conduct two types of study: those where they administer investigational medicinal products (IMPs); and those where they do not – ranging from taking blood, through to elecrocardiograms, lung function tests and other efficacy and safety assessments.

Patient safety in the drug administration type is a critical consideration. Quality organisations have a risk management process to assess the appropriateness of a drug procedure in the home; ensure they know the timing and incidence of infusion reactions and how to treat them; and will be fully trained in life support, treatment of anaphalaxis and other less severe reactions, the planning for which needs to be done with the sponsor physician. The home is not a Phase 1 unit. This is the basic minimum that should be required in any organisation carrying out home trial support on infusions.

Having said that, most infusions are safe. After reasonable exposure to humans in Phase 1, the chances of drug reactions are very small and almost always occur in the first one to three infusions. As a result, some Phase 2 and significant amounts of Phase 3 and 4 drugs are infused in the home, generally after two or three infusions have already been carried out in the hospital on that patient.

This is no riskier than the many oncology drugs which are infused in the home once on the market and can cause adverse reactions, but which are safely managed in a non-hospital setting. Indeed, most IMPs are less challenging.

Parts of the Process

A service like this needs to be considered from several angles:

  • Geographically – determining team roles and defining the final project team structure
  • Chronologically – implementing the overall project plan so that everything is set up and ready on time in all the relevant countries
  • Numerically – determining how many people the trial will need and how much of their time will be required
The resource view is very important, especially given today’s large studies, which can involve hundreds of patients in multiple countries. Home trial support organisations need to ensure they can cope with that scale, in terms of the size and training of the nursing teams involved, the scheduling and tracking of visits, and other activities such as travel time. Underlying this is the need to deliver faster recruitment and improved retention of patients, all of which has to be done with the greatest efficiency possible to keep prices down.

Data and Training Systems

Tools and methods to allow these organisations to meet the challenges of speed, scale, consistency and efficiency are key. For example, a system called MRN-SMART includes a bespoke scheduling and tracking tool for the management of large teams of nurses conducting hundreds of visits a month in multiple countries.

This pen-based electronic data capture system registers the data recorded by patients in the home and allows it to be downloaded to the site within 24 hours. It also monitors all activities and plans, and tracks visits against those plans automatically. Without such a tool, manual systems start to either overwhelm project teams as patient and visit numbers rise, or drive up prices by requiring temporary large increases in the number of members in the project team.

Similarly, as teams of nurses rapidly grow in line with recruitment acceleration, training needs increase. Bespoke tools can tackle this problem, such as an innovative training portal which helps deliver protocol-specific training, good clinical practice training, equipment and nursing competency training. This can take place at any time simultaneously to any number of nurses but still at their convenience, as well as assessing comprehension, creation of a certificate, and allowing refresher training when requested, all in the local language.

This prevents a sudden rush of training having to be delivered over the phone, or the expense of large face-to-face meetings or multiple small ones. Remember, not all nurses will be identified at the start as it is necessary to identify where the patients are going to be before allocating nurses to the visits.

Vendor Management

Vendor management is another key part of the ‘how’. To operate internationally, home trial support organisations need to build a strong and well-defined network of nurse suppliers. After all, nurses have to be located relatively close to patients to see them in their own homes and to achieve an efficient cost; it is much cheaper than sending nurses long distances. Suppliers who operate locally are the only way of achieving this.

As well as ensuring geographical reach, this approach allows only the best suppliers to be used and prevents reliance on any one company. How suppliers are chosen and utilised is therefore very important. A clear set of vendor management procedures is required as a minimum, plus a team able to develop and nurture long-term relationships to get the best possible results from suppliers.

Staff Experience

Arguably, the most important aspect of any organisation is to ensure that the people within it are well-qualified, experienced and trained. Having staff with contract research organisation and pharma experience allows home trial support organisations to understand customers directly, with a clear view of the forces that drive them, what they consider important, and how the home trial support service has to meet those demands. It also brings a strong regulatory knowledge, as well as operational expertise in project management. The nursing sector brings the aspects of operational excellence, ensuring good clinical governance and an understanding of the medical care requirements for the patients. How companies mix these skills makes a significant difference to their performance. This needs to go from the top to the bottom of the organisation. Of course, the mix also needs to take into account nursing suppliers around the globe, where the balance of nursing skills, local knowledge of the medical culture, health regulations and trial requirements will differ.

Back to Quality

As mentioned, patient safety is the most critical element, but overall quality management is also essential to make sure organisations are actually doing things in the way they have agreed. A good quality system should encompass the organisation and their suppliers and should include policy, standard operating procedures, guidelines and templates, as well as process maps and other means of planning.

The organisation should also ensure that it can measure its performance with key information and metrics, as well as audit itself both in project terms and system terms. It needs to demonstrate the ability to act on the metrics and issues raised in projects.

Robust Approach

Managing home trial support services involves a number of considerations: a robust approach to patient safety; a value proposition to improve recruitment and retention; and a clear set of operational processes that can work at scale and deliver to regulatory and medical standards in a consistent way, and deliver speed at a sensible price with an efficient team.

How this is done depends on how organisations work with their suppliers and the technology they deploy, the people who run the organisation, the project teams and the staff of their suppliers – as well as effective quality management and performance monitoring. All this will result in the effective delivery of what is a very new but ultimately powerful tool for speeding up recruitment and improving retention in clinical trials.

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Dr Graham Wylie is Chief Executive Officer of Medical Research Network, a position he has held since 2006 following a management buy-out of the clinical trials division from Healthcare at Home. He is currently developing its international growth plans through innovations such as the MRN INNOVATION suite. Graham’s career began at Pfizer running international clinical trials, before he took up director and VP level roles at Parexel.
Dr Graham Wylie
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