Envisioning a Future for Including Patient Involvement in Vocational Training in the Life Sciences Industry
Liz Clark
Independent Pharmaceutical Physician
Trishna Bharadia
Patient Leader at The Spark Global
@ TrishnaBharadia
P

atient involvement is becoming an embedded part of the life sciences industry; however, often patients are still not involved simply because industry professionals do not know how to involve them. Could the answer lie in including patient involvement as a key part of the curriculum for vocational training in the life sciences and medical technology industries? Examples from the UK show how this could be done and what it might mean for the future of professional training in these industries.

Patient involvement is becoming accepted as good practice in the design, discovery, and development of medicines and medical devices, as it becomes recognized that designing products, tools, and programs without input from users can fail to have positive impact as intended and in some cases, cause unintended harm. Both experience and data are demonstrating the benefits of patient involvement and, more recently, there have been expectations and guidance from regulatory authorities, such as the FDA and EMA, in this area. In addition, some national agencies such as the AFMPS in Belgium and the MHRA in the UK have also been active in this space. However, all too often patients are not involved, simply because those working in pharma lack awareness or don’t know how to involve them. And for those seeking simple, practical solutions, the abundance of guidance, case studies, and “how to” guides can be overwhelming if one doesn’t know where to look or where to start.

Systematic Training Is Often Overlooked in Patient Involvement Initiatives

Embedding both the mindset and habit of involving patients in the work of life sciences professionals requires an ongoing, multifaceted, cross-functional approach, of which one key component is training. Training:

  • Ensures that professionals working in life sciences are aware of the value of products, research, and initiatives that are informed by the lived experience of the people who use the medicine or device.
  • Sets standards and expectations of what “good” looks like.
  • Provides awareness of the form that patient involvement can take.
  • Helps publicize and roadmap the many resources that have been developed by groups such as Patient Focused Medicines Development (PFMD), Transcelerate, PARADIGM, and Patient Engagement Open Forum (PEOF).

Whilst some companies are implementing training initiatives to achieve these goals, such as that provided by DIA or PFMD, this training is frequently either taken only by staff with a specialist role or who have an interest in patient engagement. Therefore, inclusion of the principles and practices of patient involvement in broader professional and/or vocational training can play a key role in making it a new norm of practice.

Experience of Embedding Patient Involvement into Vocational Training in the UK

In the UK, physicians working in pharma are encouraged to complete a postgraduate medical qualification as specialists in pharmaceutical medicine. This is to produce accredited pharmaceutical physicians, who are equipped with specialist knowledge and capabilities to practice to the highest ethical and professional standards, for the benefit and safety of patients, in the development and maintenance of medicines. The Pharmaceutical Medicine Specialty Training (PMST) curriculum is built upon a framework of “Capabilities in Practice,” based on the concept of entrustable professional activities. In 2021, the Faculty of Pharmaceutical Medicine (FPM) published a major curriculum update incorporating patient involvement.

In line with the core principle of cocreation, the inclusion of collaborative patient inputs was undertaken by both representatives from pharma and experienced patient advocates. The resultant update included the incorporation of patient involvement practice from early drug development through to medicines support and ongoing evolution in clinical practice.

A set of signposted resources has also been collated and will be shared with the Educational Supervisors who oversee physicians on the training program. The result is a curriculum that features patient engagement and shared decision making throughout.

The Faculty of Pharmaceutical Medicine is a professional membership and standard-setting body that is a Faculty of the UK’s three Royal Colleges of Physicians: London, Edinburgh, and Glasgow. Its mission is to advance the science and practice of pharmaceutical medicine, with a membership base that consists of people who are medically qualified and work within the pharmaceutical industry, drug regulatory authorities, research organizations, or as independent consultants. As such, with the Faculty being the body which delivers the PMST curriculum, the training reaches all areas of the medicines development process. It means that, going forward, all UK pharmaceutical physicians who complete their specialist training in pharmaceutical medicine will be aware of the benefits of patient involvement and have some knowledge of how to undertake it.

Using similar principles, a new master’s degree in Medical Affairs run by King’s College London is also featuring patient engagement as a core element in its curriculum. Students on this course represent a broader range of participants, i.e., UK-based and international pharmacists and scientists with an interest in working in the pharma and medical technology industries. The course includes the option for dissertation topics on patient engagement, which will both encourage students to develop practical experience in the field and increase the body of evidence supporting the benefits of patient involvement.

Furthermore, having patients visible in training courses can remind participants of the value and importance of patient experience and involvement. A master’s degree course in Digital Health being run by the University of Central Lancashire has included videos of patient experiences and insights in several modules, including telehealth and the ethics of Big Data. Furthermore, the patient engagement module within the King’s College London Master’s degree in Medical Affairs will be codelivered “live” with patient advocates. This brings to life the importance of patient engagement in a clear and tangible way.

Looking to the Future

Vocational training provides the bedrock on which ongoing professional practice and development is built. As such, inclusion of patient involvement in such foundational training opens the door to the cycle of practice, reflection, and ongoing learning. The examples given demonstrate how the value and mindset of patient involvement can be incorporated in vocational training, and importantly, does so by engaging with those who have lived experience: the patients themselves. Such training can and should routinely feature in broader education and training in the life sciences industry, to produce professionals who have patient engagement embedded in their mindset from the beginning. The collaborative nature of patient involvement readily supports such professional growth. In addition, initiatives such as the Patient Engagement Open Forums, hosted by PFMD, the European Patients’ Academy on Therapeutic Innovation (EUPATI), and the European Patients’ Forum (EPF), provide natural spaces for ongoing awareness and learning.

We encourage anyone developing professional training curricula to consider how the mindset, principles, and examples of good practice in patient involvement can be included so that it becomes an everyday reality for life science professionals in the formative years of their careers. Whilst by no means a quick fix, in time we believe this may offer the most enduring results.

SUPPLEMENTAL MATERIALS

FDA guidance on patient focused drug development

MHRA’s patient involvement strategy

Patient Engagement Open Forum

FPM specialty curriculum

King’s College London, Master’s degree in Medical Affairs

University of Central Lancashire, Master’s degree in Digital Health

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