Making history together – 2022
Patient Safety Awareness Week
Maximizing patients’ safety and care in research is vital when preparing and conducting your study. In the following article we are tackling four important points you should consider during this process.
In the framework of Patient Safety Awareness Week, we believe that preventing harm in a health care setting is a public health concern. What is more, patient safety should be addressed from a holistic point of view and not just from a public health framework, the private industry plays a big role as well. As the Institute for Healthcare Improvement states:
“Everyone interacts with the health care system at some point in life. Therefore, everyone has a role to play in advancing safe health care.”
At HEMEX, we take this seriously, and patient benefit and safety are at the heart of everything we do. Our team works every day to enable better patient outcomes and provide innovative solutions to patient needs worldwide. How do we protect patient safety? By identifying, assessing, managing, and reporting any product-related risks on time. Furthermore, our work at HEMEX is to ensure that the proper documentation and regulations are implemented in the clinical development journey of the startups we work with. That’s why, today, we want to talk about four criteria that need to be considered to ensure patient safety:
1. Informed Consent
Study participants should have enough information before making a decision to join the study. That’s why it is necessary to prepare a document where the information about the key characteristics of the study are explained in a manner that the patient can understand. Here is important to include:
- Clear description of the clinical investigation.
- Any potential risks and discomforts that may or will come up.
- Explanation of alternative procedures and treatments.
- Benefits, showing the bigger picture of performing such a clinical study.
- Confidentiality and extent of information identifying the study participant.
2. Site Selection: Feasibility & Screening
Assessing the feasibility of a clinical site to conduct clinical trials is crucial to determine if the proposed clinical site can conduct the trial within the budget and the timeline while maintaining data integrity and patient safety. As a CRO (Contract Research Organisation), our work is to ensure that the trial can be conducted at the proposed site from an ethical and regulatory perspective. Selecting the right site is of utmost importance, and here there are some aspects you’ll need to consider:
- Clinical aspects
- Site demographics
- Recruitment and retention
- Ethical aspects
- Site infrastructure
- Quality
3. Patient Insurance
Persons participating in clinical trials are entitled to receive compensation for any damage suffered because of the research project. As a sponsor, you are required to cover liability through insurance or in some other manner. How can you do this? Depending on the country where you are conducting the clinical trial, you need to follow the General Insurance Conditions, which usually contain information about the contract data, insured interest & indemnification, territorial limits and trigger, limitations of cover, etc.
4. Safety Management
As mentioned, patient safety should be central for any clinical study since the preparation stages. These safety guidelines are established with a safety management plan where appropriate reporting lines, in case of an adverse event, are also defined. This plan is executed during the study with medical monitoring and a safety database is maintained according to the study-specific protocol.
As a healthcare company, our primary responsibility at HEMEX is to discover new ways to improve people’s lives. Therefore, in all our research activities, we strive to ensure participants’ rights, safety, and well-being. We are committed to a global set of core ethical principles based on the Declaration of Helsinki and the principles of Good Clinical Practice.
Want to learn more? We would love to discuss with you the best option to optimize patient safety and care coordination in your clinical trial.
Sources: IHI- Institute for Healthcare Improvement, Patient Safety Awareness Week; IHI- Institute for Healthcare Innovation, Call_to_Action; Journal of Patient Safety, A New, evidence-based Estimate of Patient Harms; The Joint Commission Journal on Quality and Patient Safety, Optimizing Patient Safety in Clinical Trials by Improving Transitions of Care; NIH, Conducting Feasibilities in Clinical Trials: An Investment to Ensure a Good Study ;Swissethics, General Insurance Conditions (GIC); ICH, Guideline for Good Clinical Practice
About HEMEX
HEMEX is committed to changing the future of healthcare by guiding the most promising European startups through each and every step to bring innovative pharmaceuticals, medical devices, and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure startups have access to a wide range of tailored products, practical solutions, and fundraising support. This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare. For more information, visit https://hemex.ch/