Clinical Trials

• LOVE FOR SELF AND FAMILY

  Giving your “Yes” is crucial in our rapid search for COVID-19 vaccine. The information generated from your participation is valuable in order for the research to move forward. Successful or not the information is helpful in showing what didn’t work and pushing research in a different direction.

• LOVE FOR COUNTRY

  When you participate in the trial, you are helping our country to have access to potential vaccine candidates.

• SOLIDARITY WITH THE WORLD

  By joining the trial, we help in the rapid worldwide search for COVID-19 vaccine. You are becoming part of the solution to end the pandemic.

Benefits

What benefits will we get from participating in vaccine clinical trials?

Clinical trials are important  for discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing the disease. They also show researchers what does and doesn’t work in humans that cannot be learned in the laboratory or in animals.

Here are the benefits that we can get from participating in vaccine clinical trials:

• We may get a new vaccine for a disease before it is available to everyone.
• We will have the chance to help others get a better vaccine for existing health problems in the country.
• Volunteers of clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others.

Risks

What are the risks to consider?

Clinical trials are ongoing research, which means that we are not sure of the outcomes and that they may come with risks:

• Clinical trials are experimental, so there is always a possibility that the vaccine may not work.
• There is a possibility that the new vaccine may cause some side effects and in extreme cases, adverse effects.
• You may NOT be part of the treatment group that gets the new treatment. Inste

Emergency Use Authorization is not the same with an approval for product registration. 

All Vaccines undergo clinical trials before they are introduced. Under the Bayanihan Act II, we have allowed the entry of vaccines which have undergone Clinical Trial Phase III (normally up to Clinical Trial Phase IV). In the published results of clinical trials conducted for COVID-19 vaccines, a lower risk of symptomatic COVID-19 was observed with vaccination compared to placebo and the incidence of serious adverse events was low.

An example is the most recently approved vaccine for emergency use authorization (EUA) by the US FDA, the BNT162b2 mRNA COVID-19 vaccine (Pfizer and Moderna) which was characterised by short term, mild-to-moderate pain at the injection site, fatigue, and headache. However, there were reported deaths but none of these was considered by the investigators to be related to the vaccine or placebo, and no COVID-19 associated deaths were observed.

Vaccines shortlisted for evaluation were scored and weighted following the WHO Criteria for COVID-19 Vaccine Prioritization and WHO Target Product Profiles for COVID-19 Vaccines with additional criteria and  considerations suited for local needs.

The following are the criteria that were used by the Task Group:

1.Potential Efficacy and Safety based on Published Phase III Interim Result and/or with  EUA
2.Technology Platform  (Reliability  and Stability Related to Storage Requirement)
3.Safety based on Phase 1 and 2 clinical trials
4.Immunogenicity  (Potential efficacy based on Phase II CT )
5.Vaccine Implementation (i.e Dosing Schedule)
6.Track record of company in developing and/or manufacturing other vaccines

For the WHO Solidarity Vaccine Trials, part of the protocol of the trial is the monitoring of the volunteers itself. All activities will be undertaken by clinical experts from various institutions and team of trialists with Good Clinical Practice (GCP)  training. Active surveillance will be done wherein weekly phone calls from the study team to monitor for COVID symptoms and potential adverse events. Follow-up monitoring will be done six (6) months up to 1.5 years after the last vaccination has been done. Specifically, monitoring will be as follows:

• Case monitoring:   Will be conducted for each individual from 14 days after the final vaccination and the cases collected 14 days after the final vaccination will be considered as valid cases.
• Efficacy follow-up will include weekly contacts to reduce loss of trial participants and to increase likelihood of detecting COVID-19 disease. Blinded study follow-up, including for adverse events, will be planned for at least one year, although for vaccines found to be substantially protective, vaccine and placebo recipients may be unblinded sooner.

• Different vaccines may possibly have different effects on different races. Hence, the conduct of local clinical trials in the Philippines will provide the vaccine developers efficacy and safety data that is directly attributed to the Filipino population.
• An EUA allows only limited use of vaccines for a certain priority group or sector. Vaccines under EUA cannot be used yet for mass vaccinations or for populations not covered by the current trials (e.g. pregnant women, those below 18 years of age, etc.).
• Long-term follow up data on safety and efficacy which can be achieved by continuing Phase III clinical trials for at least another 12 months even while there is already an EUA are still necessary to generate the evidence needed for full market authorization.
• Targeted trials on specific groups will still need to be done as well to be able to provide basis on the use of a vaccine on such groups or a specific population.
• Considering that most vaccines being procured under EUA right now have not been studied in Filipinos, local trials can generate the necessary long-term data on safety and efficacy of vaccines.

It is too early to know if COVID-19 vaccines will provide long-term protection. Additional research is needed for us to determine the long-term effect of the COVID-19 vaccines. However, it’s encouraging that available data suggest that most people who recover from COVID-19 develop an immune response that provides at least some period of protection against reinfection – although we’re still learning how strong this protection is, and how long it lasts.

The holder of the EUA shall have a comprehensive pharmacovigilance system for their product following the system or protocol for a registered drug and biological product. They shall ensure compliance to the Risk Management Plan (RMP), which contains information on product safety profile and explains the measures to characterize the risk including ongoing, new studies or additional activities. The summary of the RMP shall be published in the FDA website. Any deviation from or changes to the manufacture and changes in label of the product must be notified with the FDA. The pharmacovigilance obligations and post-authorization commitments of the holder of the EUA shall be shared by the national procurer and health program implementers to the fullest extent possible and applicable.

The following are some of the other vaccines developed and/or commercialized by some of the vaccine developers with a COVID-19 vaccine in advance stage of development:

1. Pfizer: Pneumococcal (conjugate) Prevenar 13; 10 others vaccines in the pipeline
2. Moderna: Cancer and Prophylactic vaccines (both mRNA)
3. AstraZeneca: FluMist Quadrivalent flu vaccine
4. Gamaleya: Ebola
5. Janssen: Vaccines for bacterial infections
6. Novavax: Seasonal Influenza, RSV, Ebola, MERS, SARS
7. Clover: In the pipeline: HIV, RSV, Influenza
8. Anhui: 17 clinical trials were registered on vaccines for PTB, BCG, Norovirus
9. Sinovac: Healive (Hep A), Bilive (Combined Hep A and Hep B), Anflu (Seasonal Influenza), Panflu (Pandemic Influenza H5N1), and Panflu.1 (Pandemic Influenza A H1N1)
10. Bharat Biotech: 14 vaccines including for Hib, polio, A(H1N1), rabies, rotavirus, typhoid
11. Sinopharm: No info found for other vaccines but they have therapeutic products and medical devices and equipment

Clinical trials have several stages:

Phase 1: The candidate  vaccine is given to a small number (10-100) of healthy adults with the primary aim of assessing safety

Phase 2: If the the candidates vaccine is found safe in Phase 1, it will be given to  100-1000 participants to determine how effectively it stimulates immune response and if there are any side effects;

Phase 3: If the vaccine is found to be safe and effective in Phase 2, it will be given to thousands of people (as much as ~30K) to determine if it protects a large population from the disease and whether there are any uncommon or serious side effects.

Even for vaccines that will eventually be given approval, monitoring of people who are vaccinated will still be done as there are very rare (i.e. 1 in 100,000 or 1 in 500,000 people) side effects that  large clinical trials may not capture, or  the clinical trials may not have included groups who may have higher risk of side effects than those who participated in the trials (e.g. pregnant women, older population

Vaccines are some of the most rigorously tested medical products today, and the COVID-19 vaccines are no different. The fact that the COVID-19 vaccines are available for use less than a year since the virus was discovered was not because corners were cut in the conduct of the clinical trials. Instead, the technology used to make the vaccines are the result of years of basic science research and experience with other outbreaks, as well as the continuous advancement in science and technology. All the vaccines which underwent Phase 3 clinical trials have undergone rigorous evaluation and examination by independent safety monitoring boards and have been scrutinized by the strictest regulatory agencies in the world. The vaccines with published Phase 3 trials show remarkable efficacy and impressive safety profiles. Most side effects are mild and self-limiting and very rare reports of severe adverse events. It must be noted that the results of these Phase 3 trials are “interim” because these safety and efficacy data are short term. The Phase 3 studies will continue on to completion in 1-2 years and it’s only then when we will have the full picture of its long term capability to provide protection. Having said this, in the setting of a raging pandemic where people at highest risk for contracting the disease must be protected immediately, the interim Phase 3 results and the resulting Emergency Use Authorizations from the various regulatory agencies worldwide are reliable markers that should rebalance the risk-benefit assessment towards receiving the vaccines.

Safety monitoring. The sponsor or the local CRO will be responsible for monitoring the progress of independent clinical trials. They are required to submit a monthly study progress report to the FDA. On top of that, FDA has an established process for reporting suspected adverse reactions, FDA AO No. 2016-026 which details the timelines and actions to be taken should an adverse event occur.

As we gear for the conduct of these clinical trials, we are also counting on the support of our local chief executives to generate successful outcomes.

To summarize the crucial role of our local chief executives, we would like to share with you this acronym, Lingkod TAPAT:

• Tumulong sa pangangasiwa ng clinical trials kasama ang SVT team (Assist in facilitating the clinical trials in partnership with the WHO SVT team)
• Alamin at ipagbigay alam sa WHO SVT Team ang 3 klase ng lugar na kailangan para sa trial: may mataas na kaso ng COVID-19, may mga potensyal na boluntaryo sa trial, may pasilidad sa pangangasiwa ng trial (Identify 3 key locations for the clinical trial – places with high number of COVID-19 cases, places where we can recruit volunteers, places with the facility to conduct the clinical trial)
• Pamunuan ang preparasyon sa pamayanan para sa clinical trials (Lead the preparations needed in the selected trial sites)
• Asikasuhin ang pagbuo ng Community Advisory Board (CAB) (Form the Community Advisory Board)
• Transportasyon ng mga kalahok (Facilitate and arrange the transportation needed for appointments, follow-ups, etc.)

• Assisting in conduct of Vaccine Trial in various sites identified
• Educating respective barangays on the role of clinical trials in vaccine development and safeguards in place (i.e. informed consent process, management of potential adverse events)
• Supporting info dissemination on difference of vaccine clinical trials and regular immunization programs

For independent clinical trials, discussions are ongoing with 25 biotech and pharmaceutical companies from different countries. To date, approved independent clinical trials will be conducted by:

• Sinovac
• Janssen Pharmaceuticals
• Clover Biopharmaceuticals
• WestVac Biopharma Co., Ltd.
• Inovio Pharmaceuticals, Inc.
• Shenzhen Kangtai Biological Products Co., Ltd. and Beijing Minhai Biotechnology Co., Ltd.
• Livzon Mabpharm Inc.

These clinical trials will be handled by private CROs, and will follow the protocols of the FDA. Every application undergoes a rigorous review process by the FDA, SJREB and partner evaluators, before they are approved.

You may access the approved clinical-trial applications uploaded on the Philippine Health Research Registry.

DISCLAIMER

PATNUBAY SA MGA KALAHOK NG GOOD CLINICAL PRACTICE FLIPPED CLASSROOM

Bilang paghahanda sa COVID-19 vaccine clinical trials sa Pilipinas, naglunsad ng Basic Good Clinical Practice (GCP) Training para sa Community Health Workers ang Task Group on Vaccine Evaluation and Selection, na pinamunuan ng Department of Science and Technology (DOST) kasama ang Department of Health (DOH).

Ang pamamaraan ng pagtuturo na gagamitin sa training na ito ay “flipped classroom” kung saan ang mga CHWs ay maaaring mag-aral ng mga nakatalagang paksa sa bahay batay sa kanilang sariling oras at bilis. Ang pamamaraang ito ay nakikitang mabisa sa mga mag-aaral na may limitadong oras upang dumalo sa mahabang sesyon o panayam.

Layon ng online training na bigyan ang CHWs ng tamang kaalaman sa kung paano pangangalagaan ang karapatan ng mga kalahok sa clinical trials. Ang aktibidad na ito ay siya ring magsisilbing pagkakataon upang tugunan ang mga tanong ng CHWs tungkol sa clinical trials.

Ang Basic GCP Training na ito ay libre para sa Community Health Workers.

Sino ang maaaring sumali sa online GCP Training?

Ang lahat ng Community Health Workers gaya ng City Health Worker, Municipal Health Worker, Barangay health worker, mga lisensiyadong doctor, nurse, midwife at pharmacists na nagsisilbi sa mga pampublikong health centers at ospital, at ang iba pang lisensiyadong health professionals na nagtatrabaho sa mga pang pribadong klinik o ospital ay maaaring sumali sa online GCP Training.

Ano ang kailangan para sa pagsali? 

• Kailangan ng gadget gaya ng laptop, mobile phone, tablet na may internet connection at kayang manuod ng video gamit ang YouTube at mag-access ng website
• Kailangang may email account
• Facebook account (optional)

MGA ABISO:

MGA ARALIN PARA SA GOOD CLINICAL PRACTICE FLIPPED CLASSROOM

PAALALA: Ang lahat ng materyal sa website, Youtube page at Facebook group ng DOST-PCHRD para sa Good Clinical Practice Training ay protektado ng copyright sa ilalim ng Copyright Act. Hindi maaaring kopyahin, ipamahagi, i-publish, ipakita, baguhin, lumikha ng mga gawaing hango, magpadala, ibenta, o sa anumang paraan ay pagsamantalahan ang anumang naturang nilalaman. Ang pagkopya o pag-iimbak ng anumang nilalaman ay malinaw na ipinagbabawal nang walang paunang pahintulot ng DOST-PCHRD at ng may-ari ng copyright. Para sa pahintulot na magamit ang mga lectures, mangyaring makipag-ugnay sa ricud-comm@pchrd.dost.gov.ph.

Ang nilalaman ng Facebook group at website ay ibinibigay lamang para sa mga hangaring pang-edukasyon at impormasyon. Ang PCHRD ay maaaring magdagdag, mag-ayos o magtanggal ng anumang nilalaman, patakaran, pamamaraan o regulasyon ng GCP Training.

Ipapaliwanag sa araling ito ang papel na ginagampanan ng mga Community Health Workers sa pagsasagawa ng clinical trials. Nilalayon nitong ipaunawa ang wastong mga kasanayan na dapat sundin ng mga CHWs upang matiyak na ang mga clinical trials ay sumunod sa mga ethical standards.

Pagkatapos ng pag-aaral, dapat matutunan ng kalahok ang mga sumusunod:

1.     Ano ano ang mga dapat tandaan ng Community Health Workers sa pagsasagwa ng clinical trials?
2.     Ano ano ang mga hindi dapat gawin sa pagsasagawa ng clinical trials?
3.     Ano ang responsibilidad ng Community Health Workers sa pagsasagawa ng clinical trials?

Lecturer:
Dr. Cristina Torres
Coordinator
Forum for Ethical Review Committees in the Asia and Western Pacific Region

Estimated duration:
45  minutes

Ang araling ito ay magbibigay ng gabay sa kung ano ano ang mga dapat tandaan sa pag-rekrut ng mga kalahok at nagbibigay-diin sa kahalagahan ng pagkuha ng informed consent o pahintulot ng mga lalahok sa clinical trials na batay sa itinakdang etikal na pamantayan.

Pagkatapos ng pag-aaral, dapat matutunan ng kalahok ang mga sumusunod:

1. Ano ang informed consent? Bakit ito mahalaga?
2. Ano ano ang mga dapat tandaan sa pagkuha ng consent o pahintulot ng kalahok na pagsali sa clinical trials?

Lecturer:
Ms. Edlyn B. Jimenez
Coordinator
University of the Philippines Manila Research Ethics Board

Estimated duration:
22 minutes

Ang pagsubaybay sa mga clinical trials ay isang mahalagang hakbang sa pananaliksik. Sa araling ito, tuturuan ang mga CHWs kung ano ang kahalagahan ng diary card at paano ito ginagamit para sa safety reporting and documentation sa clinical trials.

Pagkatapos ng pag-aaral, dapat matutunan ng kalahok ang mga sumusunod:

1. Ano ang Serious Adverse Events (SAE)?
2. Ano ang diary card?
3. Ano ang dapat malaman ng CHW sa paggamit ng the diary card?
4. Bakit mahalaga ang diary card sa mga lalahok sa clinical trials?

Lecturer:
Mr. Al Ryan Baniqued
Country Head, Parexel Clinical Research Philippines Ltd. Corp

Estimated duration:
22 minutes

LIST OF GCP CERTIFICATE RECIPIENTS

The names listed here belong to trainees who have satisfied all the requirements of the GCP Training Program, which include the completion of: 1) enrollment 2) pre-assessment quiz, 3) attendance to the live Q&A session, and 4) post-assessment quiz, with a score of 60% and above. The DOST and DOH certify that the following community health workers have met the minimum requirements for Basic Good Clinical Practice during community engagement.