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Watch & learn

Processing information gathered in the real world

A pair of binocularsIn recent years, licensing authorities and health technology assessment (HTA) agencies around the world have increasingly requested or required data from normal clinical practice, often termed 'real world data', to support either post-marketing commitments or reimbursement submissions. With intense pressure to demonstrate the efficacy of products, the ability to describe and demonstrate where value can be delivered once a drug is launched has clear benefit and is critical to the planning, delivery and measurement of effective healthcare.

However, gathering data about the performance of a treatment in a real world environment is not straightforward. To find out about patient outcomes the industry needs to ask the patient and this is not a dialogue it is used to having.

An understanding of normal clinical practice can be achieved through observational or non-interventional studies, which is why more and more sponsors are incorporating non-interventional studies routinely into their development programmes for new drugs. Non-interventional studies are not new but they are very different from the clinical trials that the industry is so well versed in. The broad inclusion of sites, restrictions on what can be included in the study and what constitutes an intervention, as well as their size, requires a different set of methodologies, study structures and tools to be used.

Typically non-interventional studies incorporate a large number of study sites that are much more spread out and diverse than those included in clinical trials. Traditionally, paper-based systems were used to record the data from such studies, which slowed down the research process and made it difficult to manage the study. The length of such projects meant that it was hard to see what value the study would deliver until it was completed. Advances in technology and the emergence of web-based solutions have changed this.

Data capture
Electronic Data Capture (EDC) is a technology that has already been widely used in randomised clinical trials to overcome some of the problems associated with paper-based studies. However, the scale and flexibility required for non-interventional studies has driven the need for more specialist platforms. As such, a new generation of EDC offerings designed to support the unique requirements of non-interventional studies is now available. These enable pharma companies to minimise the cost of undertaking a study and increase the speed with which data can be gathered.

Data capture systems for non-interventional studies need to be quick to implement and easy to use for non-expert users. In a non-interventional study, doctors serve as the investigators and their busy workloads make it imperative that any system they use to capture data is simple and user-friendly –with an interface more in line with the consumer experience of e-commerce and online banking than scientific clinical trials systems.

For sponsors, specialist systems also provide benefit in terms of closer contact with investigators. This can help in the building of study groups, generating interest around products and engaging in dialogue with doctors. This approach to supporting social networking within the investigator community can provide additional value and insight back to the sponsor company, as well as to the doctors themselves.

Being able to gain access to findings of studies more quickly, as well as maintaining good oversight and control over study sites and investigators is a key requirement. Using specialist EDC platforms, rather than paper, speeds up the rate at which information can be gathered and analysed. Meaningful data can be extracted at any point in the study and used to support health economic activities, as well as pharmaceutical marketing activities where appropriate.

A limitation of observational studies is that they can only observe normal clinical practice. Anything that would not normally be done by the doctor cannot be included as it is considered an intervention. This means you can watch what happens but you can't ask questions, so the dialogue with the patient remains elusive.

Online engagement
More patients are turning to the internet as their primary source of medical advice and information – a Manhattan Research study found that 90 per cent of European adults with access to the internet rely on the web to manage their health – there are ample opportunities to engage with patients online.

There is much discussion about social networking and how pharma may play a part, but blogs and communities are not the only opportunities for involvement that can deliver tangible results. If a company produces an unbiased, non-promotional online support programme that helps patients manage illness it has an opportunity to tackle concordance issues early, gather data from the programme and improve brand image. An example of this is an appointment planner that can help patients to prepare themselves ahead of a session with their doctor, encouraging them to assemble relevant information and questions before meeting.

Patient diaries can provide important data such as when or whether patients actually take doses of medication, as well as other activities and events that are taking place in their lives. Interacting in this way helps patients to assimilate information about their condition in one place, and understand patterns within their own illness. The hope is that this knowledge could help patients improve the management of their condition, for example by encouraging adherence to medication.

These tools can be used to accumulate information across a patient population, and this anonymised data set can provide insights into many aspects of illness, treatment and response.

One initiative was delivered by a pharmaceutical company in conjunction with a charity to give cancer patients information about pain management. The online tool gathered basic lifestyle information from the patient and generated a printout, including a pain map and information about medication options, which could be used in the consultation. The aim was to make it easier for patients to discuss their needs with their doctor, as well as providing more information back to the study sponsor. The result was that patients had the language and information necessary to discuss pain management options and help them make an informed choice about treatment.

Quite rightly, there are always concerns about privacy and gathering data where patients are concerned. However, harvesting data from web sites is a common practice. Amazon gives us recommendations and tells us what other people are buying, Facebook users accept that some of their information is used to improve the targeting of advertising. Compliance with the data protection legislation ensures responsible management of data, and the transparency about how data will be used to ensure that ethical standards are met.

Another approach to capturing this data is to work with medical charities and patient organisations to provide tools. These organisations will already have high-quality information on their members, making recruitment easier and enabling targeting of an existing community rather than building a new one from scratch. Providing non-product specific information and tools is an example of how to engage with a patient community while complying with regulation.

Multiple sources
Asking patients to record their own experiences is less structured than the data a study can provide. This does not devalue the information but means it needs to be treated in a different way. In situations where it is difficult to gather information through more scientific processes, this first-hand view of patient patterns can help us understand how to deliver a better standard of treatment.

Bringing this information together from multiple sources, and observing real world conditions and treatments, has the power to transform pharmaceutical marketing in a rapidly changing business climate. Moving from the blockbuster era to more targeted treatments means that patient feedback, efficacy of treatments and health economic data have to come together to demonstrate how drugs are really affecting the lives of those that take them for the better. As French surgeon and 1912 Nobel Prize winner Alexis Carrel put it: "A few observations and much reasoning lead to error; many observations and a little reasoning to truth."

The Author
Dominic Farmer is the founder and CEO of Cisiv
To comment email

6th October 2009


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