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International Clinical Trials

Home is Where the Trial is

 

The globalisation of home clinical trial support may require considerable investment and effort, but the impact on patient recruitment and retention shouldn’t be underestimated. There has been a dramatic increase in interest in carrying out clinical trial study visits in the home in the last two to three years. There are only a handful of companies globally pioneering the idea of increasing both recruitment and retention of patients in clinical trial, widely regarded as two of the most important issues facing trials today. This is illustrated by recent FDA statistics, which indicate that recruitment has fallen in clinical trials by 25 per cent and retention has fallen to as low as 49 per cent in some therapeutic areas.

A home trial support service’s value proposition is that by reducing the impact of the trial on the patient’s life – that is, by reducing the number of visits to the hospital and making the trial more ‘patient-friendly’ – it is more likely they will consent to participate, thus increasing recruitment, and be more likely to stay in, improving retention, and ultimately speeding up the trial. Although comparative data is hard to come by, what we do have shows that, even in simple trials where we are just taking blood samples and making basic patient assessments, we can increase recruitment in a site by at least 60 per cent if we handle 30 to 50 per cent of the patient visits in the home. If drug administration is also done in the home, this can increase to several hundred per cent.

The process works quite simply. The sites are signed up to the service face to face, where the process is explained, nurses introduced and so on, then the service is offered to each patient. If they consent, they are referred to the system and visits are scheduled, which typically start two to six weeks from referral. Nurses who live close to the patient are identified and trained, and proceed to make the visit with support from a central project manager or nurse manager. All data (which is source data) is collected and sent to the sites, where it is filed and monitored in the usual way. This means the service can be added straight to the standard trial process with little or no change in the function and GCP responsibilities of the site staff or those of the sponsor or CRO.

From my experience, it is easiest to start in countries where there is already a home healthcare market for registered medicines, making the acceptance and take up of the service easier. Unfortunately such a market does not really exist outside the UK in Europe, which has meant that pretty much in every country I have found the initial reaction to be ‘you can’t do that here’. Yet, in almost all cases, it is possible and the patients like it.

The Challenges Ahead

The greatest challenge is acceptance of the use of the system by the trial sites if they are not used to home care already. It is critical that the service is explained to them correctly and simply in the first instance – a task that is universally done better by the company you use for the service. Otherwise there is often a misleading conversation that takes place between a CRA – who does not know the process and often has not even spoken to the provider – and the site – who has never heard of it before and needs to understand it before they will even consider letting their patients be treated by a third party. The likely outcome is that few of the sites initially sign up, and there is a risk that the service will be set up but not used.

Some countries do not allow IV infusions in the home, or in some cases to be undertaken by a nurse at all. The majority do of course, but they will usually require the company who provides the nurse to be licensed as a home care provider and monitored as to their compliance with local regulations. Some countries also have complex laws relating to the use of sub-contracting companies – occasionally specific to healthcare, but usually applying to all forms of subcontracting – that prevent a foreign company operating in their territory unless they have a registered company affiliated in that territory.

Once the trial can proceed, there are many operational challenges. For a large trial, many nurses have to be trained to understand: the protocol; the relevant parts of GCP; how to use the specific equipment; and how to use the central lab services. For large studies recruiting across many countries and reaching up to several hundred patients a month, the training alone is a challenge. Supplying everyone with equipment and general nursing supplies, along with ensuring all the visits are identified, the protocol window they have to fall into is calculated, the nurse scheduled, and that the visit that takes place is tracked, add considerable challenges, especially when done manually. Looking for a provider who has the systems and technology in place to handle large teams of nurses making many visits a month in multiple languages is therefore a key step.

Obviously one company cannot have permanent nursing staff in every location in Europe where patients might come from in a trial. To get local nurses, it is important to be able to access local licensed companies with nurses able to perform homecare, and usually you will need several of these per region to get the best coverage. All those contracts have to be set up project-by-project; each one is created bespoke to the project, and then dismantled at the end.

Generally, most western countries are struggling with a low supply of nurses for their normal healthcare systems as the training and development of nurses has not kept up with mushrooming demand based on increasing populations who are getting older and who are creating a higher demand for complex medications. Therefore, finding nurses willing to undertake part-time work, as is inevitable in these projects, is not straightforward.

The ability of a company to meet these demands is critical to achieving the return on investment. For example, imagine you are running a 24-month trial with 400 evaluable patients and a 15 per cent drop-out rate, on which you might expect to spend £4.7 million if outsourced (therefore totally costed). If this is a blood sampling-only service, you can expect to see a speed-up of: 2.8 per cent (or 0.67 months) if only 10 per cent of sites run the service; 4.2 per cent (or 1.56 months) if 20 per cent of sites run the service; 11.7 per cent (or 2.81 months) if 50 per cent of sites run the service; and 16 per cent (or 3.83 months) if 75 per cent of sites run the service. But because of the balance of costs incurred and saved, each scenario comes out between 95 per cent to 98 per cent of the budget with no home trial support – essentially costneutral – where the main cost savings come from reducing the time of the study and, therefore, the fixed monthly management costs.

The benefits of an infusion study are even more significant as the speed up is greater. Imagine you are running an 80 evaluable patient study with a 20 per cent drop out rate, recruiting over 24 months and 12 months of therapy in a rare condition requiring monthly infusions, costing around £2.3 million. Here, you can expect to see a speed-up of seven per cent (or 2.53 months) if only 10 per cent of sites run the service, 13.4 per cent (or 5.56 months) if 20 per cent of sites run the service, 25.7 per cent (or 9.26 months) if 50 per cent of sites run the service and 38.6 per cent (or 13.39 months) if 75 per cent of sites run the service. Once again, because of the balance of costs incurred and saved, each scenario comes out at 95 per cent to 98 per cent of the budget with no home trial support. This is based on doubling recruitment in the sites running the service, which in some studies is still quite conservative.

It is critical to keep in mind that the reason for implementing this service is to achieve a speed up in the trial, and consequently, it is not critical to achieve coverage for all patients. Fifty to 75 per cent is enough to produce significant speed-ups and allows businesses to avoid those less critical countries that are harder to operate in, at least for this additional service.

Where is the Industry Going?

At this stage the sector is still young. There are not many suppliers and they have different strengths and weaknesses, but it is clear from the models that this service really pays back when it is implemented across at least 50 per cent of patients, which probably means 75 per cent of sites as not all patients sign up in each site. It is, therefore, key for the service to cover as many of the major recruitment countries as possible, which today has to include Japan, India, China and South America. Setting up these services is not a trivial task, requiring investment and signifi cant effort which for small organisations is hard to come by. Be that as it may, globalisation is required and further efforts to expand coverage will take place. Watch this space!


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Graham Wylie is Chief Executive Officer of Medical Research Network (MRN), a position he has held since 2006 following a management buy-out of Healthcare at Home. He is currently striving to further develop MRN’s strategy of international growth, differentiation and quality, building on five year’s growth. Graham’s career began at Pfizer, moving up to eventually run the Business Quality Development Group. After 10 years, he moved to Parexel as Medical Director for Northern Europe and then became Executive Director of Strategic Sales. His last position at Parexel was Vice President of Account Management for Europe before moving to Healthcare at Home in 2005. Graham holds a BSc in Pharmacology from Kings College, London and an MB BS from St Bartholemew’s College, London.
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