Challenges of sharing individual participant data for secondary research on neglected tropical diseases: the experience of Drugs for Neglected Diseases initiative and a call for action.

Introduction: The Drugs for Neglected Diseases initiative (DNDi) is committed to maximising the scientific value of the individual participant data (IPD) it has collected during its 20 years of activity and the IPD it will collect in the future, while safeguarding research participants' privacy and their right to know how their data will be processed.

Objective: The objective of this article is to share what DNDi has learnt while working on its commitment to data sharing. It also aims to advance the debate about best practice in the research community to avoid 'IPD sharing paralysis', with a focus on multistakeholder projects involving patients and researchers based in countries with various levels of data privacy regulations and measures.

Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study.

Background: The COVID-19 pandemic brought global disruption to health, society and economy, including to the conduct of clinical research. In the European Union (EU), the legal and ethical framework for research is complex and divergent. Many challenges exist in relation to the interplay of the various applicable rules, particularly with respect to compliance with the General Data Protection Regulation (GDPR).

Rethinking informed consent in the time of COVID-19: An exploratory survey.

Background: Owing to the infectious nature of COVID-19, alternative solutions, such as electronic informed consent (eIC), needed to be implemented to inform research participants about study-related information and to obtain their consent. This study aimed to investigate stakeholders' experiences with alternative consenting methods as well as their views on any regulatory or legal guidelines for eIC implementation in clinical research. Results may serve as the cornerstone to rethink the informed consent process in clinical research.

Conducting Non-COVID-19 Clinical Trials during the Pandemic: Can Today's Learning Impact Framework Efficiency?

The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of ongoing studies were issued; however, national coordination is still lacking.

Cross-Border Access to Clinical Trials in the EU: Exploratory Study on Needs and Reality.

To analyze the current situation of cross-border access to clinical trials in the EU with an overview of stakeholders' real-life experience, and to identify the needs, challenges, and potential for facilitation of cross-border access. We employed a mixed methods design. Semi-structured interviews and an online survey were conducted with a wide range of stakeholders: patient representatives, investigators/physicians, policy and regulatory experts, academic and commercial sponsor representatives, ethics committee members.