United States: Clinical Adoption Of Personalized Medicine

A recent study published in the American Journal of Medical Genetics, "Barriers for Integrating Personalized Medicine into Clinical Practice:  A Qualitative Analysis" investigated physicians' perceptions about the future of personalized medicine and identified factors that would influence their decisions in using genetic testing in their practice. The study is an interesting read for any innovator in genomic testing and analysis and provides insight into what factors will facilitate adoption of genetic testing into clinical care.

Study Design

The authors of the study, Mehdi Najafzadeh, Jennifer C. Davis, Pamela Joshi and Carlo Marra, conducted three semi-structured groups of physicians currently practicing in British Columbia (BC). Two of three groups were in urban areas and the third was in a rural setting. Each group was moderated by facilitators that assured coverage of the following pre-defined topics:

  1. Physicians' general understanding of personalized medicine;
  2. Perceived advantages of personalized medicine;
  3. Effect of personalized medicine on future of clinical practice; and
  4. Perceived barriers to integration of personalized medicine into clinical practice.

Twenty-eight physicians participated in three focus groups conducted at different locations. The majority of physicians that participated were male (67.9%) and the median age among those who reported their age was 50 years old. The mean number of years practicing among physicians was 21.0 (SD=11.2). The authors note that interestingly, the majority (approximately 68%) of participants indicated their interest in using personalized medicine in their practice if they could have access to the necessary knowledge and tools. About 22% were reported to be against the idea of applying personalized medicine and 10% of the physicians were undecided.

Results and Analysis

Physicians' General Understanding of Personalized Medicine

The authors report that about 36% of physicians self-reported that they were not familiar at all with the concept of personalized medicine prior to participation in the focus groups. Some understood that personalized medicine was the application of personal genomics to tailored treatments, while others were reported to understand it to be clinical care focused on the individual (e.g., health care management for the particular patient) and did not have any relationship to the patient's genes, a patient's family history, social history or ethnic background. Yet others were reported to believe that personalized medicine related to wealthier patients having access to personalized health care.

Perceived Advantages and Disadvantages of Personalized Medicine

Perceived major advantages of personalized medicine included improved effectiveness and a reduction in adverse effects in treatments. Uncertainty in validity, equity issues and implementation were identified as perceived disadvantages.

Uncertainty around the validity of genomic tests given the complexity of gene expression was mentioned as a major concern. In addition, substantial financial incentives for private companies for excessive marketing of their services, possible mishandling of genomic information by private companies and discrimination based on genomic information (by, for example, insurance companies, private companies and the health care system), were reported disadvantages. Lack of public knowledge about genomic tests, possible harmful impacts to patients after use and reporting of results, and affordability of genetic tests, were reported implementation barriers.

Effect of Perssonalized Medicine on Future Clinical Practice

The study participants were reported to widely believe that genetic developments will directly affect their medical practice in the future; however, they also were reported to express differing viewpoints on the timing and potential influences. Some physicians reported to have already received requests from patients for interpretation of direct-to-consumer (DTC) genetic test results, and thus, advances in genomics were already influencing clinical practice. Others opined that the effect of genomics on clinical practice might take more than 10 years to be realized.

Barriers to Integrating Personalized Medicine into Clinical Practice

The reported barriers to implementation into clinical practice included lack of training about genomic tests and interpretation of results. A lack of clinical guidelines and protocols on the use of genomic tests were other key issues of concern to the physicians. The physicians also noted that the complexity of reporting and interpreting test results to patients were additional barriers to implementation.

Discussion and Notes For Innovators

In conclusion, the authors believe that despite the challenges that personalized medicine can create for the participating physicians; there was a general interest in using genetic information in their practice. The authors also believe that physicians expected to have access to training opportunities and clinical guidelines in order to use the genomic testing and interpret the results. Interesting, the authors noted that the cost of genomic testing and who would pay for the tests was one of the reported major themes raised in the focus groups.

The authors also raise the point that although many genomic tools are not currently ready for clinical practice, there was a consensus among the study participants that given the fast pace of genomic science, there is a need to be prepared for evaluating and implementing technologies upon their availability. The authors opine that creating the capacity in the health care system can be a lengthy and timely reaction to advanced medical technologies can maximize the benefits and minimize the harms associated with their use.

The authors note that many of the physicians in the study received their medical training before any of the currently available genetic tests existed. While the authors state that this highlights the responsibility of organizations that are involved with training physicians and the oversight of medical care to provide adequate training and education, innovators who develop and market such tests should also appreciate that many practicing physicians presently lack the support and training to interpret and communicate test results to patients.

Clinical application of genetic information to inform treatment decisions, a basic application of personalized medicine, must therefore understand and meet the needs of a primary consumer – the treating physician. Thus, training and on-going support to physicians and genetic counselors (that support physicians) are important to successful adoption of genomic tests that support personalized health care.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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