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Posted 21st January 2013 in Articles | Register to comment

Sally Bull and Andy Turner

Complete True Life

When planning a medical communications strategy, Sally Bull and Andy Turner discuss the importance of including real-world evidence-based research in order to support value demonstration in the development of pharmaceutical products.

Real-world observational patient studies are becoming a necessity to support value demonstration in the development of pharmaceutical products, both to validate early marketing insights and to support evidence-based health economic arguments as part of the reimbursement process.

We believe that real-world observational patient studies need to be embraced within medical communications planning to provide clear and relevant messages to all key stakeholders ? health-care professionals, patients, payers and governments.

The role of medical communications

A medical communications agency will work closely with a pharmaceutical brand team to ensure all the relevant data that supports the product reaches the target audiences in a clear and consistent way, using a wide range of media. This includes, but is not exclusive to, journal articles, congress posters, learning resources, scientific slide kits, animations, materials for sales representatives, and media materials to support PR. Digital communication tools, such as social media initiatives, are also employed in communicating the brand story, and are becoming an increasingly important resource in the brand teams? communication tool kit.

?There is now, however, an increasing requirement from stakeholders to evaluate the effectiveness of medicines when used in routine clinical practice??

The core principle of medical communications is to use these different channels to educate and inform a wide variety of stakeholders about the risks and benefits of new therapies. This has historically been supported by the use of clinical data from Randomised Controlled Trials (RCTs) which provides evidence on efficacy and safety for healthcare interventions.

The rise of real-world studies

There is now, however, an increasing requirement from stakeholders to evaluate the effectiveness of medicines when used in routine clinical practice by conducting real-world observational patient studies.

By conducting a real-world study, additional information is made available to understand patient populations, patient sub-groups, health resource use, cost effectiveness / utility arguments and patient reported outcomes. This all needs to be clearly packaged and communicated in alignment with the clinical data to support the best chances for successful reimbursement.

The patient as a key stakeholder

An increasingly important element of this communication is now centring on the patient as a key stakeholder.

Understanding the patient journey in relation to the management of a condition over time is a central requirement. Key questions that can be asked in a real-world observational study to help support this are:

? What type of treatment does the patient receive?

? What influence does the patient have over treatment decisions?

? Which health care professionals has the patient seen on the journey and at which stage?

? How long has a diagnosis taken?

? How long after the diagnosis was a medication prescribed?

? What switching patterns occur and at what decision points are these switches taking place?

Real-world studies provide an opportunity to hear the patient voice by recording information from the physician on presenting patients and then matching it with data collected directly from the patient.

?Real-world studies provide an opportunity to hear the patient voice??

Data collected directly from the patient can incorporate validated Patient Reported Outcomes (PRO) measures to gain a robust understanding of specific areas relating to their condition, including Health Related Quality of Life (HRQoL), severity, symptoms, and functionality.

Understanding routine clinical practice for insights and evidence

Real-world studies open a ?true-to-life? window on what is happening in routine clinical practice and can add to the weight of evidence already provided by the clinical trial programme. This evidence can be gathered either to validate early insights work in the development of establishing brand value or to provide evidence based health outcomes / economic arguments to support the reimbursement process.

Real-world insights

Data from real-world studies can assist in validating hypothesis that have been developed from early insights work to demonstrate what value a new product will need to exhibit in order to maximise the opportunity for market access.

Medical communications companies that can offer a deeper understanding of how to incorporate real-world insights to identify the most appropriate channels for targeting value demonstration, which will ultimately provide enhanced communications for their target audience.

The communication of messages associated with a specific sub- group of the patient population, where the unmet need matches the value proposition for the brand, will have greater success than generating generic messages to the total population.

Real-world evidence

Identification of evidence gaps via real-studies rather than the clinical trial programme can provide additional opportunities for medical communications.

There is an increasing need, particularly from payers, to provide additional publishable real-world evidence which can be included as part of the reimbursement submission.

?There is an increasing need, particularly from payers, to provide additional publishable real-world evidence??

Evidence that demonstrates the burden of illness within a defined real-world patient population can then be associated with the value of reducing the burden with the selected intervention. By showing this in real clinical practice, the drug is more likely to gain a favourable reimbursement decision.

An understanding of how to utilise real-world studies to support these evidence gaps again provides additional opportunities for enhanced medical communications.

The message is clear; real-world studies are a vital tool in medical communications, and will become increasingly important in the near future as the information they provide is sought by physicians, patients, and payers within the healthcare system.

As part of the medical communications planning process, serious consideration should be made to understand the relevance and need for real-world insights and evidence based research to add value and validity to your recommendations.