Published on Oct 02, 2025
The changing regulatory environment for clinical trials requires sponsors and Clinical Research Organisations (CROs) to manage risks and obligations related to intellectual property (IP) rights, transparency, participant consent, and data protection.
Accordingly, clinical trial agreements (CTAs) are crucial for successful research collaborations but contain several legal challenges that need careful consideration. In-house counsel must identify and address key risk areas to safeguard their company's interests.
Clinical trials frequently produce valuable intellectual property, such as patents and know-how relating to new drugs, therapies, medical devices, and treatment methods. Proper drafting and negotiation of IP rights, confidentiality, and publication clauses are vital to safeguard the interests of all parties involved.
Ambiguity over the ownership of study data, inventions, or improvements can lead to expensive disputes. Agreements should clearly define ownership of background IP, foreground IP, and joint discoveries. Companies should consider implementing tiered rights frameworks that address different contribution scenarios and establish clear mechanisms for licensing and commercialisation pathways.
Balancing academic freedom with proprietary interests requires well-crafted publication provisions. Overly restrictive clauses can discourage prestigious institutions, while inadequate controls may lead to competitive disadvantages. Companies should consider implementing review periods instead of approval rights, limiting redactions to confidential information, and setting reasonable publication timelines to protect both scientific integrity and commercial interests.
Transparency is essential for building public trust to support advancing scientific knowledge. Sponsors and CROs must be aware of their transparency obligations when conducting clinical trials. The new Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 in the UK update transparency requirements in clinical trials and aim to streamline and accelerate processes over patient consent to participation in trials.
Trial-related injuries represent both ethical and legal concerns for all parties. Clear compensation provisions can mitigate risks associated with reputational damage and potential litigation. It’s important to detail the scope of covered injuries, compensation mechanisms, claims procedures, and any excluded circumstances. Agreements should also distinguish between immediate medical care and long-term compensation, and ensure consistency with informed consent language to avoid conflicting obligations.
CTAs must navigate an increasingly complex global regulatory landscape. Sponsors must ensure that relevant clinical trial authorisations and ethics committee approvals are in place for each site where the trial will take place. Good Clinical Practice (GCP) guidance allocates regulatory responsibilities to the trial sponsor, investigator, and site, which should be appropriately reflected in the CTA. The CTA should also include robust audit rights and mandatory notification obligations in relation to safety issues. Sponsors should also be aware of the circumstances when mandatory CTA templates must be used for certain trials rather than internal company templates. For example, in the UK, the mCTA or CRO-mCTA must be used for industry-sponsored clinical trials of investigational medicinal products with NHS participants in hospitals throughout the UK Health Services.
Clear payment provisions that detail cost allocations, budget and relevant payment procedures are important for CTAs. Agreements should include clear procedures for budget modifications and should address trial close out costs in the event of early termination of the trial. Sponsors will also need to be mindful of their wider transparency obligations with respect to transfers of value to healthcare institutions and healthcare professionals (as may be required under relevant industry codes of practice), which should be reflected in the CTA.
Ending a clinical trial early can be a complicated process and appropriate terms in the CTA should be included to account for this procedure and safeguard patient safety. The CTA should clearly set out the potential grounds for termination with appropriate notice periods. The parties will also need to ensure that they comply with any continuing obligations after the termination of the CTA. Detailing obligations regarding ongoing patient care and safety reporting, record retention obligations, and investigational product disposition following termination are all important.
Data protection regulations, including the General Data Protection Regulation (GDPR), impose stringent requirements on the use of patient data during and after clinical trials.
Before drafting a CTA, the parties must determine their role under applicable privacy laws in light of the factual circumstances of their collaboration and the stance taken by local data protection regulators. Following this assessment, the parties need to ensure that their obligations for lawful, fair, and transparent processing of personal data as well as international data transfers are properly reflected in the CTA.
Furthermore, informed consent from a medical regulatory perspective may need to be enhanced to also cover any privacy-related consent requirements. This requires a detailed understanding of proposals relating to data processing and sharing activities before drafting informed consent documentation.
Information security breaches carry severe consequences. Hence, the parties must understand the various security breach requirements they are subject to and determine the data security measures appropriate for processing patient data. Following this assessment, the CTA should cover the necessary notification obligations towards the other party and cooperation duties in case of a security breach.
Effective CTA drafting requires balancing multiple stakeholder interests while maintaining sufficient clarity to guide complex research relationships. By focusing attention on these critical risk areas, in-house counsel can draft agreements that not only protect organisational interests but also facilitate successful clinical development programs while minimising the potential of downstream disputes.
To learn more about CTAs in the life sciences sector join our expert trainers on our new Clinical Trial Agreements: Key Legal, Regulatory and IP Considerations for the EU and UK Markets training course. Experts from both Osborne Clarke and Covington & Burling LLP share their wealth of knowledge and will take you through the legal, policy and IP considerations which underpin this highly regulated area.
Published on Oct 02, 2025 by Angela Spall