wave

Ingrid Klingmann

Dr. med. Ingrid Klingmann, is the Chairman at European Forum for Good Clinical Practice (EFGCP).

What is your day-to-day work like? How do you help improve or save people's lives through your work?

I’m a physician and clinical pharmacologist also specialised in General Medicine. In recent years, I’ve worked as medical advisor for pharmaceutical companies and academic institutions and have also been heavily involved in numerous clinical investigations and trials.

I am actively involved in developing and accelerating multi-stakeholder discussions to ensure treatment development processes are ethically sound, that patients have access to safe and effective treatment, and that patients actively engage in new treatment research and development.

Indeed, I am of the opinion that only patients are expert at providing the patient experience and their voice is crucial.  

 

How can we encourage more patient involvement in health policy and decision-making?

There is a growing interest in involving patients in research, development and access to treatment mechanisms. However, such involvement is more efficient when patients are knowledgeable in methodologies and principles.   The cohort of ‘educated’, informed patients and patient advocates is growing, although there is still a long way to go. Initiatives like the Innovative Medicines Initiative (IMI)-funded ‘patients’ academy’, EUPATI, are crucial in encouraging more patients to be involved in healthcare policy and decision-making, in a meaningful way.

One great example of EUPATI’s success to date is a patient training course involving 100 patients from across Europe gaining expert-level insights into medicines research and development over a 14-month period. The course, incorporates face-to-face training and e-learning methodologies.

There’s also a free, shareable EUPATI toolbox which provides patients and advocates with a wealth of information on the medicines development process including videos, factsheets, presentations which has been translated into 7 languages with more expected in the coming months. This online toolbox has been a huge success, accessed in its first 3 months by over 20 000 people globally.

As the project, which is funded by the European Commission and the pharmaceutical industry, comes to an end in the coming months, the next obvious step for me is finding means to expand EUPATI to patients interested in  medtech treatments. This would be an excellent opportunity both for patients and the industry in my opinion.

 

What do you think are the top three challenges facing the healthcare system and your profession in particular?

  • Lack of interest by the public in how medical treatment is developed is a concern. While people generally have an interest in health and well-being, there is a poor understanding and lack of active engagement in how medicines and technologies are developed, how they are designed and how they are tested.
  • The variance in competence by those who create medical devices and diagnostic tests on collaborating with patients is a challenge. While I’m sure manufacturers have the best intentions, I think there’s room for improvement in how medtech partners with patients and ensures patient expertise is being considered.
  • Involving patients and the centrality of the patient voice is still not common place. I believe that manufacturers of medical technologies need to change their methodologies to proactively incorporate the patient perspective into how they develop devices and diagnostics and be considered as part of the development team.

 

What role do you see for medical technologies to address these challenges?

The medtech sector could engage more in multi-stakeholder discussions about the ethical and societal aspects of medtech product development, , rather than focusing primarily on the technical features and the price of the product.

 

If you had one ask to the industry, what would it be?

My ‘ask’ to medtech would be to create an environment for multi-stakeholder collaboration that would encourage discussions on numerous important issues such as reliable effectiveness, safety and ethical principles. Indeed, creating a culture and mindset of understanding and supporting the value of open cross-communications amongst stakeholders is needed.

 

If you had one ask to the decision-makers, what would it be?

It would be to establish a legal and quality framework for reliably ethical and safe development of new medtech treatments while ensuring the growth of the strongly needed innovative medtech sector.  The ‘ICH guidelines’ for global medicines development harmonised the technical and ethical standards allowing mutual recognition of data generated in one region. .The ISO guidelines go some way to enhance technical standardisation, but there is a need for more development on the ethical and safety standard side and a mechanism to enforce these guidelines in national legislation.

 

What would you want to see/what is your vision for the care of your patients in the future and healthcare overall?

I would love for patients to have guaranteed access to reliably safe and affordable treatment. I also would like to see patients being involved from the beginning in legislation like the Medical Devices Regulation (MDR) and patient input being incorporated into the development of medical devices.

The next step for the MDR legislation is the implementation acts and I think the EFGCP Medical Technology Stakeholder Alliance can play a great role in providing concrete solutions as a ‘think-tank’ in moving the implementation of the legislation along.