IFAPP Today newsletter clipping, April 2022 Number 23 about the HEART approach for leading drug development

04. April 2022 : The HEART Approach for Clinical Trial Leadership


Project management vs Project leadership

New drug development remains highly risky and costly despite the fact that approval success rates increased to 62% in 2017 (Galson et al., Nature, 2021). Galson et al. name poor execution and inadequate project management as one of the factors causing every third study to fail in phase III. 

We believe that the success of clinical trials can be improved by executing strong project leadership in addition to traditional project management techniques. One of the biggest challenges for life-science start-ups and small biotech companies is the development of a clear strategic path that will successfully bring their product to market. Hence, clinical development leadership addresses this very issue by identifying the products strongest advantages in terms of market needs and value and developing a streamlined clinical trial program that helps these companies succeed.

Based on extensive knowledge of the regulatory environment, the clinical project leader establishes a high-level project vision, can identify alternatives, and proposes new approaches. The project leader also takes ownership for the study as part of the whole drug development programme by stepping out of visionless execution and being able to see the long-term perspective of their decisions. 

In modern clinical development, there is an urgent need for a stronger project leadership mindset implemented in the early stages of clinical trials. We suggest applying the HEART approach for leading drug and device development programmes successfully:

o   High-level vision: understanding and reviewing regularly where the sponsor’s expectations meet market needs. 

o   Expert: profound clinical and regulatory knowledge should be a prerequisite. However, it is a valuable trait to recognise in time whether it is necessary to involve an expert, as this can be a decisive moment for the success or failure of the clinical trial. Inadequate selection of biomarkers or selection of the wrong target population could thus be easily avoided in hundreds of clinical trials.

o   Adaptive approach: staying open-minded and flexible. Every clinical trial is similar and unique at the same time. Propose new approaches in routine tasks. 

o   Responsibility: responsible project leaders are expected to account for multiple constraints and demands from a range of stakeholders. It includes not only sponsor, clinical operations, and study team, but also patients and the health care system in general. Bring solutions to the market and fill the gaps. 

And last, but not least

o   Team: strong communication and coordination skills play a crucial role in a complex and dynamic process of drug development. Good project leadership possesses full integrity and commitment to the team. K. Murray in his book Charismatic Leadership states that a team under charismatic leadership is 24 percent more likely to give discretionary effort. Listen and do what was said. 

Project managers learn from the outside in mastering techniques and skills. Project leaders develop themselves from the inside out investigating their weak and strong traits; emotional intelligence, adapting their communication to the need of the team and stakeholders. While management is the process of working with others to ensure the effective execution and accomplishment of a chosen set of goals, leadership is about developing what the goals should be. It is about driving change, whereby the journey is as important as the outcome.

Can the clinical trial succeed with an application of solely project management? Yes, definitively. However, under a discrete project leadership, the pathway from idea to market would be rationalised, streamlined, and sustainable.


·       S. Galson et al. Nature Reviews Drug Discovery 20, 259-260 (2021) doi: https://doi.org/10.1038/d41573-020-00167-0

·       K. Murray Charismatic Leadership: The Skills You Can Learn to Motivate High Performance in Others. Kogan Page (2020).

Kerstin Peschel-Credner, PhD (Senior project manager at Gouya Insights KG, member of GPMed [Austrian Association of Pharmaceutical Medicine]); 

Kateryna Uspenska, PhD (Senior project manager at Gouya Insights KG; member of the IFAPP Young Professional WG, member of GPMed [Austrian Association of Pharmaceutical Medicine]).

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