LS&HC Horizons 2023 - Flipbook - Page 11
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Clinical Trials
11
11
Collaborative research is blurring boundaries
between sponsored studies and IIS
Industry is revising its models in clinical
development: new collaborative research
between the industry and investigators is
becoming more important, resulting in an inbetween approach between industry sponsored
studies and investigator initiated studies
(IIS). In this model, industry does not want
to incur the sole-sponsor or co-sponsor role,
or wishes to limit its responsibility as a (co-)
sponsor. At the same time, it may intervene
or extend control on a number of aspects
beyond the limited involvement in IIS, for
instance, initiation of the project, input to
study design, arranging supply of products and
funding, stronger rights on ownership and use
of study results, more control in relationship
with authorities and third party stakeholders,
extensive collaboration on elaborating the
study report and publications, etc.
Compared to the typical IIS approach,
collaborative work allows industry to ensure
better alignment of the project with its clinical
development strategy. Key points need
to be borne in mind for structuring these
relationships, including:
• regulatory role allocation must be clear from
the outset in all relevant documentation;
• tasks described under the contract and
related documentation must be consistent;
• if the collaborating institution is still
intended to be the sole sponsor, it needs to
retain decision-making power. This requires
a subtle balance in governance to secure
oversight and protection and desired control
for the industry. In case of co-sponsoring,
the allocation of responsibilities is even
more important;
• IP ownership and use must take into account
industry contribution, with further rights
granted vs. IIS;
• the hybrid nature of these studies will require
amending contract provisions deriving from
both sponsored and ISS studies;
• key documentation must be legally
reviewed to spot inconsistencies and
risk of reclassification as sponsor or cosponsor (e.g., contract must be explicit on
subcontracting of regulatory tasks); and
• civil law liability and indemnification to be
specified in close alignment with roles and
actual activities.
Mikael Salmela
Partner, Paris
Dr. Jörg Schickert
Partner, Munich
