Lecture 6 Patient Centricity and Legalities

Patient Centricity

A healthcare approach that prioritizes the needs, preferences, and values of patients in care decisions and practices, emphasizing active patient engagement and collaboration.

Five Cs

Co-design, communication, convenience, compensation, continuous feedback

Why is diversity in clinical trials important

Diversity in clinical trials is crucial because it ensures that research findings are applicable to a broader population, addressing variations in responses to treatments due to genetic, environmental, health condition, and social factors. This inclusivity helps improve the safety and efficacy of therapies across different demographic groups.

decentralized clinical trials

A method that leverages technology to conduct clinical trials remotely, allowing participants to engage from their homes while maintaining rigorous data integrity and compliance.

PAGs

patient Advocacy groups

ICH

An international organization that sets ethical and scientific standards for clinical trials, facilitating the harmonization of regulatory requirements across different regions.

EMA

The European Medicines Agency, responsible for evaluating and supervising medicinal products in the European Union.

PFDD

A patient-focused drug development initiative by the FDA that emphasizes collecting patient insights on their experiences with a disease and its treatment.

ESG

An investment strategy that considers environmental, social, and governance factors in evaluating companies and their impact on society.

Technology Transfer

the process of transferring scientific findings from one organization to another for the purpose of further development and commercialization

What are the benefits of technology transfer

increase funding for research (more interest, more money in the field),return on public investment, provides incentive for excellence and innovation, powerful engine for economic development, and direct benefit to the public

what are the cons to technological transfer

change in organizational culture, blocks to scientific research (more limited in scope to maximize end result) may influence researcher’s agenda and scientific findings

Bayh-Dol act

A US legislation that facilitated technology transfer from federally funded research to the private sector, promoting commercialization and innovation.

TTOs

Technology Transfer Offices, which facilitate the commercialization of research innovations by licensing technologies developed in academic and research institutions.

In israel, employee invention is owned by the institution per:

law, or in a hospital/lab owned by the government, it is owned by the government

In the US, employee invention is owned by the institution per:

agreement

IP

intellectual property

MTA

material transfer agreement that governs the transfer of tangible research materials between organizations. It outlines the rights and responsibilities of both parties involved in the transfer.

indemnity

protection against legal liability or claims for damages.

What are the three Rs?

replacement, refinement, reduction. These terms apply to avoiding use of animals in trials wherever possible

ICF

Informed Consent Form that ensures patients understand the details of a clinical trial and voluntarily agree to participate.

Compassionate use

refers to the use of an investigational drug or treatment outside of clinical trials to treat patients with serious conditions when no other options are available.

What are the three elements required for an ICF

information, consent, and privacy + insurance/indemnication

GDPR

General Data Protection Regulation, which is a comprehensive data privacy law in the European Union that governs the processing of personal data for individuals.

CCPA

California Consumer Privacy Act, a law that enhances privacy rights and consumer protection for residents of California.

HIPAA

Health Insurance Portability and Accountability Act, a U.S. law that establishes standards for the protection of sensitive patient health information.

What rights shoudl be protected for trial sites (for the sponsor of the research/ CRO) ?

Confidentiality, IP, Publication, Insurance, Liability and Indemnication, Audit rights

EHDS

European Health Data Space, an initiative aimed at enabling secure access to health data across Europe to promote better healthcare services and research.

eCOA

electronic Clinical Outcome Assessment, a method of collecting patient-reported outcomes using digital platforms to improve data accuracy and patient engagement.