South Africa's NHLS Cyberattack: Overcoming Clinical Trial Challenges

The recent ransomware attack on South Africa's National Health Laboratory Service (NHLS) has sent shockwaves through the healthcare industry, significantly impacting clinical trial operations. This cyberattack, initiated in June 2024, has crippled the NHLS's ability to communicate lab results, posing a substantial hurdle for clinical trial teams.

Impact on Clinical Trials

The disruption caused by the NHLS cyberattack presents a major challenge for clinical trial operations. Lab results are crucial for participant screening and eligibility. The current system outage has led to delays in participant enrollment and disrupted study timelines. While challenging, it's essential to remember that the NHLS system will eventually be restored.

Overcoming Obstacles

Effective communication with protocol teams and sponsors is vital for developing contingency plans. Collaborating can minimize the NHLS cyberattack's impact on clinical trial progress. One potential solution is utilizing verbal lab results as a temporary measure. This approach can expedite screening and enrollment while maintaining data accuracy and patient safety through strict protocols.

Ensuring Good Clinical Practice with Verbal Lab Results

To maintain data integrity and patient safety when relying on verbal lab results, adhere to ICH GCP guidelines (ICH GCP Guideline, 2018):

• Carefully document all verbal lab results on a standardized form.

• Have two people independently record the information.

• Document the name of the person providing the lab results over the phone.

• Quickly enter the results into the study's electronic data capture system.

• Check the entered data for errors.

• Compare verbal results to electronic records once the NHLS system is back online.

By following these steps, you can maintain data integrity and comply with GCP guidelines.

Your Path Forward

Navigating the complexities of the NHLS cyberattack demands strategic planning and expert support. By maintaining open communication and adhering to GCP guidelines, clinical trial teams can mitigate this crisis's impact. Partnering with a clinical trial consulting firm can provide essential expertise for tailored solutions and research continuity.

Remember, you're not alone in facing these challenges. By sharing experiences and best practices, the clinical trial community can collectively overcome this obstacle.