World Patient Safety Day calls for global solidarity and concerted action by all countries and international partners to improve patient safety. 

The Day brings together patients, families, caregivers, communities, health workers, healthcare leaders, and policymakers to show their commitment to patient safety. 

How to Ensure Patient Safety During a Clinical Trial? 

Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. As the first step towards ensuring patient safety, healthcare providers need to be respectful and responsive toward patients’ needs, comfort, and preferences, that is ensuring a patient-centric approach. A proactive methodology nurtures better patient enrollment with an increased retention rate. 

Different conflicts of patient safety across the phases that may affect the Clinical Trial 

  • The issues arising from clinical trials are not always intentional but are frequently due to the complexity of the overall system. 
  • Often patients having comorbidity are randomized to receive a clinical trial, risking this population of patients. 
  • Lack of proper training of medical professionals restricts and hinders a safe and well-organized clinical trial. 

All these together can impose safety issues on the patient populations and risk the clinical research company’s brand value. Thus, sponsors, researchers, CROs, healthcare providers, and sites need to collaborate for better outcomes and patient safety during clinical testing or clinical trial study.  

How to address the most common Patient-Safety issues in a clinical trial?  

  • Foster a responsible organizational culture within the clinical trial study 

It is important to develop an organizational culture where everyone is equally responsible for the safety of their co-workers, patients, and themselves. Clinical research companies, sponsors, and decision-makers must foster a culture of open communication and encourage the resolution of issues related to safety.  

  • Open communication to ensure patient retention during clinical testing 

Open communication between patients, physicians, and caregivers can help improve patient safety. Regular communication, either personally or through integrated clinical trial solutions can improve trust and help in understanding the effects of the clinical trial better. 

A centralized platform for all the data related to the study with multiple access and multi-gadget configurability will also drive open and effective communication, enabling the physicians to provide a well-balanced overview of medical options to the patients for rational decision-making. This way the patients can also make more informed decisions. 

  • Well-trained care providers to conduct patient-centric clinical trials 

Along with fostering open communications, care providers can benefit from additional training programs to ensure patient safety, and another important factor in patient safety is the eConsent. Patients need to be informed about the entire process along with the associated risks, adversities, procedures, and any other required information to facilitate voluntary and rational subject participation. According to a study, e-learning is an effective way to increase patient safety knowledge, which can be combined with face-to-face instructions.  

  • Ensure that qualified, experienced, and licensed Principal investigators (PI) are on board 

PI is responsible for monitoring and doing the needful for patient care and well-being. PI checks for any variations in the readings of clinical testing even if it is a subtle one because they might flare up and create adverse effects. Thus, sponsors should ensure that qualified, experienced, and licensed PIs are onboard. 

  • Using a robust platform to regulate the trials and ensure patient safety 

The success of decentralized trials depends on the robust database and adherence to data safety guidelines. Hence, the software system used to support any clinical trial must be 21 CFR Part 11, ICH-GCP, HIPAA, GDPR, and International Standards Compliant.