Articles Tagged with: COVID-19
Home / Blog Archives
Jul
14

Beyond COVID-19! Learn to live with New Normal Life

Beyond COVID-19! Learn to live with New Normal Life

The world is now several months into the “Coronavirus disease (COVID-19)” global pandemic caused by the SARS-CoV-2 virus. As lockdown restrictions slowly begin to lift in certain regions, the pursuit for a safe and effective vaccine against the virus continues – and more research groups are joining the efforts.

Over the course of 2020, the COVID-19 pandemic has caused an unprecedented global crisis, resulting in a devastating death toll and threatening our economic order and societal structures. It started in late 2019 and now has infected more than 200 countries and territories. On 20th June 2020, WHO has reported globally 8,525,042 confirmed cases (Americas- 4,163,813; Europe- 2,509,750; Eastern Mediterranean 878,428; South-East Asia- 560,825; Africa- 208,535; Western Pacific- 203,490) including 456,973 deaths over time.

The COVID-19 (coronavirus) pandemic has substantial health, social, and economic impacts in all countries, rich and poor. It is a sharp reminder that everyone everywhere should have access to quality and affordable health services. We will be living with COVID-19 and its consequences for a long time to come.

Humans are blessed with the clinical research industry. This industry is working around the clock efficiently to find the treatment or cure for COVID 19. There are so many clinical trials that are ongoing in the whole world to get a permanent treatment for this novel coronavirus.

The World Health Organization recognizes that, as of July 9, there are over 140 vaccines in various stages of development. Some are being fast-tracked by regulatory authorities, whilst others remain at the very early stages of pre-clinical testing.

Clinical research industry has escalated the efforts in the development of vaccines against COVID 19. The pharmaceutical industry and research sectors are working to develop the prophylactic vaccine by using different platforms including mRNA, DNA, adenoviral vector, and recombinant protein. We at ProRelix Research are feeling privileged in supporting some of the industrial efforts through our clinical research services.

Health systems has now been facing the dual challenge of responding to the outbreak and maintaining routine services which we have never thought that we would be facing.

COVID-19 demands that we think about global protection and calls for a renewed and urgent focus on specific public health systems to overcome this critical situation that mankind has been facing now. This includes special attention to disease surveillance, laboratories and diagnosis, health information systems, communications about changing behaviors, engagement of communities, and building public trust in the health system.

COVID-19 is a global crisis requiring sustained international solidarity and action. Strengthening our community and health care system has an important role to play in bringing partners together on a joint vision for resilient health systems and priority actions.

Conclusion:

Hopefully, a new norm is emerging where we share information across countries, collectively coordinate resources, and work jointly for the survival of the human race. And more importantly, live on a planet where we don’t mess with nature. Hopefully, we find the balance and make sure that we don’t overconsume what we have given, we spend more time with our families and take care of our health more.

References:

1. https://pubmed.ncbi.nlm.nih.gov/32365466/
2. https://covid19.who.int/
3. https://pubmed.ncbi.nlm.nih.gov/32295814/
4. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novelcoronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
5. https://www.ayush.gov.in/docs/123.pdf
6. http://apjai-journal.org/wp-content/uploads/2020/03/1.pdf
7. file:///C:/Users/Admin/Downloads/novel-coronavirus-landscape-covid-19-24062020.pdf
8. https://www.who.int/health-topics/international-health-regulations#tab=tab_1
9. https://www.who.int/health-topics/common-goods-for-health#tab=tab_1

Jun
24

Regulatory Guidance For Clinical Trials Conduct in India During COVID-19 – Public Health Emerg …

Regulatory Guidance For Clinical Trials Conduct in India During COVID-19

– Public Health Emergency

The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the healthcare system and broader society, and the impact it may have on clinical trials and subjects. The present situation across the country may affect approved protocol adherence, regulatory provisions/procedures, trial subjects’ recruitment, laboratory testing, and the supply of investigational products, adverse event reporting, visits, assessments, and many other aspects of clinical trial conduct.

To address the present crisis, CDSCO issued a new notification for conducting clinical trials in India. This guidance covers actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority. The below guidance will provide further clarity for all parties involved in clinical trials during this time in India.

Guidance on the Management of Clinical Trials during COVID-19 in India:

• As per the New Drugs and Clinical trials Rules, 2019, the sponsor will conduct any clinical trial as per approved clinical trial protocol and other related documents. The trials must comply with the Good Clinical Trial Practice (GCP) Guidelines and the provision of said rules.
• The Central Drug Authority reiterates patient rights, wellbeing, and safety are of paramount importance even at this hour of crisis.
• In the present situation, the sponsor of all ongoing clinical trials needs to coordinate with investigators and respective Ethics Committee (EC) and decide on whether to continue the trial or otherwise in the interest of trial subjects.
• There may be a necessity, in some cases, of protocol amendment or deviation or modification in the procedures of the clinical trials due to unavoidable circumstances. The sponsor, in consultation with the investigator and EC, should assess any such impact and take appropriate decisions whenever necessary. Such changes should ensure the rights, safety, and wellbeing of trial subjects, and the integrity of clinical data remains uncompromised.
• The sponsor needs to maintain complete records of all changes in the clinical trial, including the reasons for any amendments or deviations in the study.
• The sponsor needs to maintain complete records of all changes in the clinical trial, including the reasons for any amendments or deviations in the study.
• Any submissions or reporting related to the above changes in the conduct of clinical trials can be made to CDSCO by email at [email protected] and with a copy marked to the concerned division of CDSCO (HQ).
CDSCO understands the various challenges in the conduct of clinical trials during the COVID-19 pandemic in India and has come up with the new guidance to help conduct clinical trials at this hour of crisis

Reference:

Gazette notification F. No-DCGI/MISC/2020(104), Government of India, Director General of Health Services, Central Drug Standard Control Organization. Dated 30th March 2020.

About Us

ProRelix Research is the best clinical research organization (CRO) with global service capability supporting Phase 1, 2, 3, & 4 clinical trials for Pharma, Biotech, Biopharma, Medical device, Nutraceutical & Herbal companies in US, India, Australia, & Europe.

Services
Subscribe Blogs & Newsletter
Legal Center
Copyright © 2021 Reserved at ProRelix Services LLP .
Inquire Now
close slider





      Register Now

      All the fields are mandatory