Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.

Personalized Medicine: The Educational Disconnect

Without educational support in their evolving role, physicians will be unable to advise their patients, and those patients will look elsewhere for information.



Personalized medicine has the potential to transform patient outcomes across a wide range of therapy areas, but recent research shows that physicians in clinical practice feel unprepared for this revolution. The absence of formal training in this field means that educational support is required for doctors to navigate the scientific and logistical complexities of the personalized medicine era. The pharma industry will need to adapt its approach to scientific communications and medical education to address the knowledge gaps in the medical community, enabling healthcare practitioners to engage most effectively with their patients.

As an increasing number of targeted therapies and companion diagnostics reach the market, access to credible scientific evidence will be a priority, leading to a clear opportunity for the industry. Encouragingly, physicians are receptive to information on personalized medicine, and a recent study by the Adelphi Group has demonstrated the opportunity for pharma companies to raise their profile as education providers in this field.

Predictably, traditional communication channels will remain relevant, with 86% of physicians expecting to use medical conferences and peer-reviewed journals as sources of information on this subject in the future. However, direct communication from the industry is also welcomed, with over half of the doctors surveyed expressing an interest in receiving educational material on personalized medicine directly from pharmaceutical and diagnostics companies. This is a particularly interesting opportunity since only 17% of physicians cite industry as a current provider of information on this topic.

Direct contact with physicians through a thoughtfully developed educational program is an excellent way of tapping into the positivity identified by this research.

The enthusiasm for engagement with industry also extended to clinical trials, with 70% of specialists expressing a willingness to participate in future trials of personalized therapies. Direct contact with physicians through a thoughtfully developed educational program is an excellent way of tapping into the positivity identified by this research, and ensuring that physicians are equipped to give their patients access to the most innovative and promising clinical trials.

It is important to remember that today’s physicians are also concerned with the economics of healthcare, not only in terms of cost but also the potential additional resource requirements of new treatments. Physicians highlighted time and resource management, and costs to the patient and healthcare provider as major concerns, along with the need for clear guidance for clinical decision-making, and the challenges surrounding the ethics of personalized medicine. A commitment to closer engagement and strategic guidance will enable the industry to bring clarity to these areas and remove barriers to understanding which currently exist.

Doctors have limited time with each patient, and this may not be sufficient to explain complex test results and their implications. How can a physician explain a decision to withhold treatment based on a genetic biomarker if the doctor is not confident in the data supporting that decision? Can we expect physicians to follow the latest scientific literature with an increasing number of complex targeted therapies and diagnostics entering the market? And in the age of the "expert patient," with un-validated information widely available online, how will we support physicians to respond if their decisions are challenged by a patient who appears to be extremely well informed?

Uncertainty expressed by the grassroots physicians in this survey suggests that this approach is not working for personalized medicine.

Many medical education activities engage a core of key experts who help to lead the communication of new clinical practices, but the uncertainty expressed by the grassroots physicians in this survey suggests that this approach is not working for personalized medicine. So what can be done differently to provide the support that physicians so clearly need?

In part this can be addressed at the strategic level of the development process by avoiding late decision-making and ensuring clarity in communications. All too often companies embark on Phase III trials before asking "What is our diagnostics partner saying?" This represents a missed opportunity to provide clear and consistent communications to the end user. Several pharma companies are formulating parallel streams for therapeutic and diagnostic development, aiming to pursue biomarker identification at an early stage, even during lead optimization and candidate drug selection. While robust diagnostic data may not be available early on, this model remains an aspirational goal for many in the industry and creates an opportunity to develop a truly integrated franchise communication strategy at an early stage of drug development.

It is also important that there is timely clinical validation of the diagnostic, and that this is communicated with the results of the pharmaceutical trials. By bringing in stakeholders from the diagnostic development team early, the biomarker and its clinical validation can be built into the scientific platform for the product. Furthermore, if a pathway view is taken of the disease then the scientific platform may need to account for multiple biomarkers and their roles in relation to various targeted agents within the disease area portfolio and the competitive landscape. While elements of the plan will undoubtedly change during the development process, the integrated team will be well placed to respond and update the plan accordingly. Then, once budget becomes available for medical education in later stages of the drug/diagnostic development process, the scientific platform can be used to ensure that clear and robust scientific data are available to the medical community.

Relevant information needs to reach the prescribing physician and the end user of the assay, but in personalized medicine in particular, an effective medical education program needs innovative components which reach beyond the physician to other healthcare professionals who will help make personalized medicine a reality. These may include genetic counselors, who were identified by three-quarters of physicians as being critical for engagement with patients. A third of physicians also identified a need for "personalized medicine health coaches," a role which does not yet exist but was proposed by doctors who feel unsupported in this rapidly evolving area.

Personalized medicine is a complex field and there are many stakeholders who can drive prescription decisions. Simply identifying new information channels is not enough – it is becoming necessary to build a healthcare communications platform that will resonate with and can be interpreted by those different audiences. Is industry filling the role of the "personalized medicine health coach" that physicians are looking for? Without educational communications that support their evolving role, physicians will be unable to act in the best interests of their patients, and those patients will look elsewhere for information. Without a sound knowledge base for decision-making, patient outcomes must undoubtedly suffer.

Extracts from a study of 446 oncologists, cardiologists, neurologists, and PCPs in the USA and EU designed and conducted during Summer 2012 by the Adelphi Group in association with CAHG and Medefield.

For further information please contact jackie.morgan@adelphigroup.com


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Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.

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