How to Ensure Patient Safety During a Clinical Trial

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Monitoring patient safety during a clinical trial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinical trial phases. This enables a better ecosystem for patient safety for improved outcomes.  Further, a collaborative approach promotes informed decision-making among the patients with better trust in the on-going clinical trial procedure and enthusiastic participation.

As the first step towards ensuring patient safety, healthcare providers need to be respectful and responsive towards patient’s needs, comfort, and preferences i.e. ensuring a patient-centric approach.  A proactive methodology nurtures better patient enrollment with an increased retention rate.

Regulatory bodies governing clinical trials

Further, as mentioned in NCBI, all clinical trials need to be conducted following established standards like International Conference on Harmonization Good Clinical Practice (ICH-GCP) Guidelines, International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations Medical Sciences (CIOMS), and the ethical principles outlined in the Declaration of Helsinki.

What are the different conflicts across the clinical trial phases?

  • The issues that arise from clinical trials are not always intentional but are often due to the complexity of the overall system.
  • Often patients who have a problem are randomized to receive a clinical trial. This population of patients is always at risk.
  • 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 a better outcome and patient safety during clinical testing or clinical trial study. Here is a quick guide for CROs and sponsors to help sites to be more efficient.

How to address the 5 most common  patient safety issues in a clinical trial:

  1. 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. Needless to say, that safety should be prioritized over financial/budgetary goals or operational goals.

The clinical trial budgets should always be created in consideration of patient safety and risk assessments. This can be achieved when clinical research companies, sponsors, and decision-makers foster a culture of open communication and encourage the resolution of issues related to safety.

  1. Open communication to ensure patient retention during clinical testing

Open communications between patients and physicians can help improve patient safety. Regular communication (either personally or through integrated CTMS 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. This will also enable 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.

  1. Well trained care providers to conduct the patient-centric clinical trial

Along with fostering open communications, care providers can benefit from additional training programs to ensure patient safety. For example, simulation-based training helps care providers to a great extent. Animated stories of real patient stories and patient problems are not only engaging but help the young care providers to understand real-life scenarios and how to respond to such problems across the clinical trial phases.

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. 

  1. The role of Principal Investigator (PI) oversight and patient safety in a clinical trial services

PI is usually a licensed and experienced doctor who monitors the trial volunteers closely during phase 1 of the study. Despite being enrolled as a healthy patient, the volunteer might have borderline hypertension or high BMI (full form), that were not on records.

Later during the clinical trial, if the volunteer develops complications from the drug administered, the onus lies with the PI to monitor and do the needful for patient care and well-being. It is the PI’s responsibility to check for any variations in the readings of clinical testing even if it is a subtle one, considering the fact that they might flare up and create adverse effects. Thus, sponsors should ensure that qualified, experienced, and licensed PIs are onboard.

  1. The role of the Institutional Review Board (IRB) in ensuring patient safety

 IRB is an independent board of physicians and other appropriate parties. The IRB monitors every clinical trial service that undergoes in the US to ensure the clinical trial is conducted ethically. Even if the clinical trial study is conducted outside the US, there are similar review boards that ensure patient safety through the vigilant administration of guidelines during clinical research. The main responsibilities of IRB include:

  • Review and approval for study protocols prepared by study sites
  • Ensures any amendments in the clinical study protocol is duly listed and conveyed across by the site
  • Ensure proper informed consent from patients regarding research study and proposed side effects, if any
  • Minimization of risk for patients
  • Ensuring ration risk vs benefit ratio

Patient safety and clinical trial solutions in the times of COVID-19

A recent update from the US Food and Drug Administration (FDA) mentions that new drug investigators need to report all adverse events to their respective review boards, taking into consideration the COVID-19 pandemic.


Ensuring patient safety should be a collaborative approach between sponsors and healthcare providers. It should have a patient-centric approach, and every stakeholder should do their bit to ensure that the health and safety of patients are not compromised at any time. Only then, more patients can rely on the clinical testing and participate in new clinical trial studies enthusiastically.

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