Guidelines for the conduct of clinical trials during public health emergencies and pandemics In Kenya

Public health emergencies and pandemics cause major disruptions and greatly affect the way the world operates.

There is noticeable disruption of clinical trials conduct due to the public health emergencies and pandemics, majorly owing to the preventive measures put in place which may include Presidential and Ministry of Health directives on. Additionally, there is usually increased demand on health services provision leading to the reallocation of some of the clinical trials staff, coupled with the need of self-isolation by some of the trial participants. These factors are likely to impact on the oversight resulting into a negative impact on the initiation of new trials, difficulties in maintaining a medical oversight of the studies by the investigators, completion of trial assessments, completion of trial follow-up visits and the provision of Investigational Medicinal Products (IMPs).

The impact of public health emergencies and pandemics on ongoing trials, on opening a new trial site in an existing trial, ongoing recruitment, and continued involvement of participants in the trial, or on starting of new trials should be considered. This evaluation should take into consideration the Kenyan Government recommendations and restrictive measures including travel restrictions and confinements of trial participants and trial staff and the availability of trial staff to perform visits, enter data in the Case Report Form (CRF), notify serious adverse events and, more generally, follow the protocol.

Our response to the public health emergencies and pandemics challenge should be in line with several key principles and considerations. These include but are not limited to:

1. Compliance with the WHO and Ministry of Health’s Directives on Public health emergencies and pandemics

2. The safety and well-being of patients, research participants and their families, and health care professionals, researchers and other staff involved in patient care and research are paramount.

2. 3. It is critical that public health systems remain able to respond to the needs of the community, both those impacted by public health emergencies and pandemics and in terms of regular workloads.
3. 4. The conduct of research related to public health emergencies and pandemics is a significant priority; however, the initiation and continuation of other ongoing and proposed research should also be critical for the well-being of patients, participants, communities, and the research sector.
4. 5. Compliance with or adherence to regulations, guidelines, codes, policies, and other standards remains necessary. However, interpretation of research responsibilities in the context of a crisis such as public health emergencies and pandemics should be informed by flexibility, consultation, and good sense to retain the focus on the safety and well-being of those most at risk in our institutions and communities.
5. 6. Possibilities of invalidating outcomes of on-going studies as a result of confounders due to public health emergencies and pandemics and associated factors.
6. 7. Reference to international guidance from e.g., FDA, EMA, MHRA, TGA (but local/national government guidance is supreme)