Clinical Data Collaboration in search of COVID-19 Treatments

& The CTI Use-Case

Collation and collaboration of clinical trial data underpins the strategy to find effective and safe COVID-19 treatments. In this strategy, the importance of sharing data, and deriving timely insights from this data is clear. The world is seeing an unprecedented number of research efforts to help combat the global COVID-19 pandemic. Understanding the biology, epidemiology, transmission, and evolution of the virus puts the scientific community one step closer to creating diagnostics, therapeutics, and effective vaccines. One of the greatest challenges at this stage is finding ways to rapidly access and share data and results, which we are now seeing at an unprecedented level.

ClinTex welcomes this new paradigm of collaboration to speed up the development of COVID-19 treatments, and strongly believes that this collaboration should be at the heart of all medicines development in the future.

For example, “Solidarity” is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners. The Solidarity trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.

The treatment options under study include:

Remdesivir was previously tested as an Ebola treatment. It has generated promising results in animal studies for Middle East Respiratory Syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS), which are also caused by coronaviruses, suggesting it may have some effect in patients with COVID-19.

Lopinavir/Ritonavir is a licensed treatment for HIV. Evidence for COVID-19, MERS and SARS is yet to show it can improve clinical outcomes or prevent infection. This trial aims to identify and confirm any benefit for COVID-19 patients. While there are indications from laboratory experiments that this combination may be effective against COVID-19, studies done so far in COVID-19 patients have been inconclusive.

Interferon beta-1a is used to treat multiple sclerosis.

Chloroquine and hydroxychloroquine are very closely related and used to treat malaria and rheumatology conditions respectively. In China and France, small studies provided some indications of possible benefit of chloroquine phosphate against pneumonia caused by COVID-19 but need confirmation through randomized trials.

Another example of new efforts in collaboration is the European COVID-19 Data Platform aims to address data sharing challenges by providing an open, trusted, and scalable platform where researchers can store and share relevant datasets. It will also create a shared computational space where scientists and public health workers can collaborate. The data platform will be connected to the European Open Science Cloud (EOSC).

The European COVID-19 Data Platform consists of two connected components:

SARS-CoV-2 Data Hubs, which will organise the flow of sequence data from the outbreak and provide comprehensive open data sharing for the European and global research communities.

The COVID-19 Portal, which will bring together and continuously update relevant COVID-19 datasets and tools.

These short term fixes will certainly improve the collaboration and data sharing required for the current pandemic. ClinTex CTi aims to bring this level of collaboration to all medicines development in the future for all disease areas, and believes co-operation across the pharmaceutical industry should be the norm, and not just in response to emergencies.

“There is only one way the world can exit this pandemic — and that is through science. We need diagnostics to detect and limit the spread of this virus, vaccines to provide long-term protection, treatments to save lives in the shorter-term and social science to understand the behavioural and societal implications. It’s critical that the global research effort is rapid, robust and is conducted at scale and co-ordinated across multiple countries” — Dr Jeremy Farrar, Director of Wellcome and Chair of the WHO R&D Blueprint Scientific Advisory Group