10 ways pharmaceuticals can connect consent across clinical development

In the dynamic world of pharmaceutical research and development, the journey from the inception of a novel drug or therapy to its final approval and market availability is a complex and highly regulated process.

Central to this process is the vital concept of informed consent, a cornerstone of ethical research.

As pharmaceutical companies venture into innovative clinical development models and technologies, the question arises: how can they effectively connect consent across the entire spectrum of clinical trials and research phases?

With countless technology systems and different platforms collecting consent data at different stages of the consumer journey, the risk increases for mistaken communications, incorrect attribution of consent and conflicting profiles.

Consider this: a study published in the Journal of Medical Ethics found that only 31% of clinical trials fully disclosed the risk of serious adverse events to study participants in their informed consent forms. This glaring gap in ethical disclosure underscores the pressing need for a more holistic approach to consent management in clinical development.

Furthermore, according to the Center for Information and Study on Clinical Research Participation (CISCRP), nearly 85% of clinical trial participants feel inadequately informed about their roles and the potential risks and benefits of participation. These statistics paint a stark picture, highlighting the critical imperative for pharmaceutical companies to bridge the consent gap effectively.

Whilst disruptive technologies and transformative research paradigms have become the norm, the importance of informed consent cannot be overstated. It isn’t just a matter of meeting regulatory requirements; it’s about adhering to the highest ethical standards, promoting transparency, and empowering participants to make informed decisions about their involvement in clinical trials.

Download: A guide to centralized consent in clinical development

In this article, we will explore 10 actionable ways in which pharmaceutical companies can bridge the gap and ensure seamless, ethical consent management throughout clinical development.

1. Unified consent platforms

To streamline the consent process, consider implementing unified consent platforms that span all phases of clinical development. This central hub can ensure that the consent forms, language, and procedures remain consistent, improving efficiency and maintaining a high standard of ethical practice.

2. Early engagement and education

Engage with potential participants early in the process. Provide them with accessible information about the study, its goals, and the importance of informed consent. Educated participants are more likely to understand and provide consent willingly.

3. Digital consent tools

Leverage digital tools to facilitate consent, such as e-consent platforms and mobile apps. These user-friendly solutions can improve the efficiency of the consent process while allowing for detailed explanations and a straightforward way for participants to consent electronically.

4. Multilingual and accessible materials

Ensure that consent materials are available in multiple languages and designed for accessibility. This approach caters to diverse participant populations and helps bridge language and accessibility barriers.

5. Dynamic informed consent

Consider implementing dynamic informed consent processes that adapt to individual participant needs. Such a system allows for personalized explanations and interactive discussions to ensure that participants fully comprehend the study and can provide informed consent.

6. Continuous communication

Maintain ongoing communication with participants throughout the study, providing regular updates, answering questions, and seeking feedback. This approach fosters trust and transparency, reinforcing the importance of consent at every stage.

7. Consent reiteration

While it may seem repetitive, reiterate the consent process at key milestones or changes in the study. Revisiting and reconfirming consent ensures that participants remain engaged and informed throughout the clinical development journey.

8. Data privacy and security measures

Implement stringent data privacy and security measures to protect participants’ sensitive information. Participants need to trust that their data is secure and used only for the study’s intended purposes.

9. Ethical review committees

Establish internal ethical review committees that monitor the consent process and ensure compliance with ethical standards. These committees can help identify and address any ethical concerns that may arise during clinical development.

10. Continuous training

Invest in ongoing training for all staff involved in the consent process. This includes researchers, clinicians, and administrators. Well-informed and well-trained staff are better equipped to handle consent-related challenges effectively.

Connecting consent in clinical development

Connecting consent across all phases of pharmaceutical clinical development is essential. It ensures that research is conducted ethically, participants are well-informed, and regulatory requirements are met.

As pharmaceutical companies embrace innovative models and technologies, these actionable strategies can help bridge the gap and create a seamless, ethical consent management process throughout the journey from drug discovery to market approval.