The EU Clinical Trials Directive (European Directive 2001/20/EC), which was designed to streamline the trial application process and harmonize it across Europe had a large impact on the IIT conduct, as the administrative work and costs became significantly huge.
To help keep innovation alive and keep a check on the translational research gap, non-profit health organizations and the patient foundations have taken a growing role at distinct levels of research and development process at academic research institutions. To accelerate the innovative side of the academic research some foundations adopted the success of the “Orphan Disease” approach and rigorous stratification of funding mechanisms to support the innovation from target identification to the first trials in humans. (Hoey 2007, Hartmann 2012, Yang DX 2013).
Contrary to traditional approach and scientific merit selection, the non-profit organizations and patient fund foundations take a qualified investigator driven and multi stakeholder approach. Health foundations or charities increasingly demonstrate that PPPs can be instrumental in obtaining maximum benefit for the patients they serve. Moreover, these foundations can offer the necessary clinical network and access to patients. (Zaratin 2014, de Vrueh 2017).
Numerous health foundations were originally founded by patients (or their caretaker/representatives) with a key objective: Both find treatments and a cure for a specific disease or group of diseases. In Europe, a relevant example of such a multi stakeholder initiative is the Innovative Medicines Initiative 2 (IMI2) (https://www.imi.europa.eu/about-imi).
An even wider network of investigator-driven research is the European Clinical Research Infrastructure Network (ECRIN). It was established in 2004 to become an organization that could facilitate multinational clinical trials in Europe. ECRIN’s first project (2004 ‑ 2005) focused on strategy, the second (2006 ‑ 2008) on tools, and the third (2008 ‑ 2012) on infrastructure development. These projects were followed by additional projects, such as ECRIN Integrating Activity or ECRIN-IA (2012 ‑ 2017) and, most recently, the Paediatric Clinical Research Infrastructure Network or PedCRIN (2017 ‑ 2020) (https://www.ecrin.org ).
Finally, regulatory and health technology assessment agencies, such as the EMA and the Dutch Medicines Evaluation Board, also see the PPP model as a platform that allows them to share data, expertise, resources, and to enhance their understanding of other stakeholders’ perspectives (https://www.ema.europa.eu/en).