SOP's, Protocols and Study Materials Shared with The Global Health Network

Groups across Africa, Asia and Latin America are sharing their approaches in what they are measuring and how - through their SOPs and training resources - to support a faster implementation of research studies during this pandemic. You can read more about this crowdsourcin iniciative and access this material here or click the below direct links to the study profiles.

In an effort to contribute to the global research efforts into COVID-19, a team based at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC) in Lahore, Pakistan are leading the participation of five sites in the WHO-led SOLIDARITY Trial. The team have adapted and modified the protocol to fit the nature and resources of their setting and received ethical approval from their local review boards to conduct the trial across 5 sites.

The team in Pakistan have generously provided access to the SOP's and documentation they have developed to support this trial at their sites.

Click on the topic below to explore this study implementation map

 

KAP COVID

In July 2020, over 3,000 US citizens took part in a survey in order to understand attitudes towards public health intervention methods. This visualisation is designed to inform policy makers and public health officials on their public health messages related to COVID-19.

Protocol Development

Protocol development is an essential first step in turning any research question into a study. Exisiting protocol development tools can be adapted to allow rapid, effective protocol development during the COVID-19 Pandemic.

This Protocol Development Toolkit, developed by The European & Developing Countries Clinical Trials Partnership (EDCTP), aims to support researchers in the protocol development process by providing the tools and guidance to produce a high-quality health research Protocol.

Resources

WHO

Coronavirus disease (COVID-2019) R&D Blueprint
The R&D Blueprint is a global strategy and preparedness plan that allows the rapid activation of R&D activities during epidemics. Its aim is to fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large scale crisis. Below are the latest WHO R&D reports relating to COVID-19 therapeutics. 

International Clinical Trials Registry Platform
The main aim of the WHO ICTRP is to facilitate the prospective registration of the WHO Trial Registration Data Set on all clinical trials, and to allow the public accessibility of that information.

Database of publications on coronavirus disease (COVID-19)
The WHO is gathering the latest scientific findings and knowledge on coronavirus disease (COVID-19) and compiling it in a database. The database is updated daily from searches of bibliographic databases, hand searches of the table of contents of relevant journals, and the addition of other relevant scientific articles.

EMA

Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
Developed by the European Commission and the Head of Medicines Agencies (HMA), the guidance includes specific advice on clinical trials for COVID-19 treatments, including the need for large, multi-national trial protocols. This is line with the CHMP's call urging the EU research community to pritoritise such studies as they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments.

SIDP

Experimental Agent Reviews
Members from the Society of Infectious Diseases Pharmacists have prepared brief, evidence-based reviews of potential pharmacotherapeutic treatment options for COVID-19. These video presentations and handouts will be updated regularly as new data emerge on each of these experimental therapies. 

ASHP

Assessment of Evidence for COVID-19-Related Treatments
The American Society of Health-System Pharmacists provides this evidence table to help practitioners better understand current approaches related to treatment and care. The information contained in this evidence table is emerging and rapidly evolving because of ongoing research and is subject to the professional judgment and interpretation of the practitioner due to the uniqueness of each medical facility’s approach to the care of patients with COVID-19 and the needs of individual patients.

TRC Healthcare

COVID-19 and Pharmacotherapy
These charts provides information or resources on pharmacotherapy of interest for COVID-19, and address common questions about pharmacotherapy as it relates to COVID-19.

University of Liverpool

The Liverpool Drug Interaction Group (based at the University of Liverpool, UK), in collaboration with the University Hospital of Basel (Switzerland) and Radboud UMC (Netherlands), have produced various materials in PDF format to aid the use of experimental agents in the treatment of COVID-19:

Administration in cases of swallowing difficulties

Data

Veridata EDC
On 26/03/2020, Elsevier launched Veridata EDC, a secure, compliant and user-friendly platform to capture patient data for clinical research. To assist researchers working to develop vaccines and other therapies for COVID-19, Elsevier has pledged to make Veridata EDC available for free. Interested clinical researchers can contact Elsevier customer support via e-mail at covid19@elsevier.com and apply for a demo account. Following the necessary compliance training, you will receive a free 12-month license.

Training

Tools

This hub aims to facilitate and provide guidance on several topics related to clinical trials, with resources including a Protocol Development Toolkit, a Data Management Portal and a Data Sharing Toolkit.

This tool packages a wide range of practical information about managing trials in low and middle-income countries into a single software tool. Available in English and Spanish. 

These templates have been shared by other groups, and are free to use and adapt for your research studies. Please ensure that you read and adapt them carefully for your own setting.

The Liverpool Drug Interaction Group provides a freely available drug-drug interaction resource. Read more

  • Webinar on Anaphylaxis to COVID-19 Vaccines

January 18, 2021

Dr. Kathy Edward’s presented on anaphylaxis to COVID-19 vaccines during an meta-DSMB meeting on January 13th, 2021.

For the recording, please click here.