DOH Steering Committee for the Clinical Trials for COVID-19

The National Steering Committee for the conduct of clinical trials for investigational therapies for COVID-19 is a body that was created by virtue of DPO 2020-1377 to ensure the necessary oversight in the screening and administration of the investigational therapies for COVID-19 patients and ensure their safety and well-being.

Frequently asked questions

  1. Provide oversight functions on the conduct of clinical trials in investigational therapies for COVID-19;
  2. Develop strategic plans, policy guidelines and mechanisms for the conduct of clinical trials for investigational treatment for COVID-19 infection in the participating hospitals;
  3. Ensure that clinical trial investigators and participating hospitals are following the approved protocols of Single Joint Research Ethics Board (SJREB) and the FDA;
  4. Review and decide on requests for DOH sponsorship of clinical trials; and
  5. Decide on reported issues and other technical and administrative concerns of the trials.

The DOH Steering Committee is currently headed by the following DOH officials as follows:

 

Chairperson:      DR. MARIA ROSARIO S. VERGEIRE, MPH, CESO IV

                                OIC – Undersecretary of Health

                                Health Regulation Team

 

Vice – Chair:       DR. NESTOR F. SANTIAGO, JR., MPHC, MHSA, CESO II

                                Assistant Secretary of Health

                                Public Health Services Team

                       

On the other hand, the members of the Steering Committee consist of the offices of the Department of Health are as follows:

 

  1. Health Regulation Team (HRT)
  2. Bureau of International Health Cooperation (BIHC)
  3. Disease Prevention and Control Bureau (DPCB) – Emerging and Re-emerging Infectious Disease Program (EREID)
  4. Epidemiology Bureau (EB)
  5. Health Facilities and Services Regulatory Bureau (HFSRB)
  6. Health Policy Development and Planning Bureau (HPDPB) – Health Research Division (HRD)
  7. Health Technology Assessment Unit (HTAU)
  8. Legal Service (LS)
  9. Procurement and Supply Chain Management Team (PSCMT) – Logistics Management Division (LMD)

 

The functions of each office are provided in the DPO No. 2020-1377.

 

Moreover, the World Health Organization (WHO), Food and Drug Administration (FDA), SJREB, and participating hospitals can be invited by the Steering Committee as resource persons.

The Steering Committee has already convened three (3) times and shall regularly have meetings until completion of its tasks regarding the conduct of clinical trials related to COVID-19. It shall be automatically terminated immediately upon completion of the clinical trials.

  1. Obligations of the DOH being a clinical trial sponsor
  2. Deployment of investigational drugs
  3. WHO Solidarity Trial on therapeutics and vaccines
  4. Favipiravir (Avigan) Trial
  5. Other clinical trials for COVID-19
  6. Organization and SOP for the Drug Safety Monitoring Committee (DSMC)
  7. Draft issuances regarding clinical trial sponsorship by the DOH

The Steering Committee regularly meets to discuss updates on clinical trials for COVID-19 including the vaccines Solidarity Trial. Among the updates was the participation of the DOH in the Solidarity Trial as follows:

    • The DOST is the chair and the DOH is the co-chair of the IATF Sub-TWG for vaccines and the focal of the conduct of Phase 3 clinical trial in the country by vaccine developers.
    • DOH – Public Health Services Team (PHST) was identified as the focal for the vaccine developers who will express interest to sell.
    • The DOH – Procurement and Supply Chain Management Team (PSCMT) is designated as the team for the readiness of the cold chain capacity of DOH.

No. They perform their roles pro bono.

Related Issuances

News and updates regarding on the DOH Steering Committee for the Clinical Trials for COVID-19

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