The global Clinical Trial Tracker was designed to help stakeholders make informed decisions regarding how to allocate resources, better understand the dynamics of the global response to the pandemic and support discovery of therapies. Its dashboard provides an overview of all COVID-19 trials taking place around the world.
Edward Mills (EM), vice president of real-world evidence and senior principal scientist at Cytel, spoke with Outsourcing-Pharma (OSP) about the Clinical Trial Tracker and how it might help accelerate development of therapies.
OSP: Could you please tell me how and why you decided to create the Clinical Trial Tracker?
EM: This terrible pandemic has inspired a lot of goodwill and collaboration within the pharmaceutical industry, an industry known for its harsh competitive drive. As we work with colleagues all over the world, we saw this humanitarian effort as a paradigm shift, but one which needed new tools.
We quickly realized that scientists in different parts of the world were commencing similar investigational studies because they were not aware of the work being conducted in other countries. Similarly, philanthropists and policymakers had no idea which the most promising studies were, so could not identify the groups that should receive the scarce funding available.
Finally, what information there was, was not trickling out fast enough. For example, a local politician might need to know what studies are going on in his or her area so that those who have coronavirus can access those clinical trials. All of this information needed to be located in a central repository.
It is these challenges that inspired the development of the COVID-19 Trial Tracker — the Tracker aimed to facilitate more informed and transparent decision-making amongst scientists, philanthropists and policymakers.
OSP: Please describe the tracker itself — what it does, who might make use of it, and what kinds of information are found and shared.
EM: The COVID-19 Trial Tracker lists registered trials, the countries in which they are operating, whether they are recruiting and what the results are. For each trial there are details about therapy, outcome and findings.
There is also a Cumulative Registration tab that enables you to see how many trials have been started and when and where they began. So, for example, you see clearly that across April 2020, over 100 trials began in the United States, which is an extraordinary number.
A Cumulative Recruitment tab shows you what current and expected recruitment looks like per therapeutic. You can see, for instance, when a trial is projected to end, and how many people those conducting the trial expect to recruit in a given month.
OSP: How did the Gates Foundation come into play — did you approach them, or vice versa?
EM: Cytel scientists have a standing relationship with the Gates Foundation due to the work that we do in the global health arena, particularly in low- and middle-income countries. The COVID-19 Trial Tracker was built quickly because we already had a relationship with them.
OSP: Why is collaboration on COVID-19-related work in the industry important?
The reasons are endless, but here are three.
First, COVID-19 presents challenges that no one individual or organization is positioned to solve. We still have so little knowledge about this strain of coronavirus.
Only six weeks ago the majority of people still believed that it would only affect those over the age of 60, or those with pre-existing conditions. This meant that there was a lot of initial guesswork being done by scientists, so the more knowledge that is aggregated the better.
Secondly, data is being collected all over the world. Without collaboration, efforts will be replicated, which means that patients will possibly be exposed to therapies that have already been tested and been found to be subpar; we can expedite drug discovery by aggregating collected data.
Third, we need to identify the most promising results quickly, and find ways to deploy them across the world. There is a real urgency here; we need to be very honest about the fact that a very expensive therapy will not be accessible to everyone, and fund research for those therapies that can benefit the most people.
The only way to identify these therapies is greater transparency, easy comparisons, and open dialogue. Given the absence of publications about what is being discovered, collaboration is absolutely essential.
OSP: Does Cytel have any previous such tools they’ve created or collaborated on in the past?
EM: Cytel has several software products that have been used for trial design, and our flagship software, called East, is currently being used to design trials for some COVID-19 therapies. We also have a new communications platform that will be released later this year, which uses simulations to help decision-makers understand the wide terrain of trial design options that they have.
Currently, we also have a trial reforecasting tool called Enforesys. These are not for trials investigating COVID-19 therapies, but rather for those that have been disrupted by the coronavirus pandemic.
OSP: Have you or any colleagues been touched by COVID-19 personally?
EM: Our headquarters is right outside of Boston, which is a bit of a hotspot right now, and we also have offices in Geneva, Paris, Barcelona and a number of cities experiencing difficulties. As people in biomedicine, we also know lots of doctors and clinicians on the front lines of the epidemic. It is certainly very intense and worrying.
OSP: Is there anything you would like to add?
EM: The humanitarian work being done by medical practitioners, scientists and policymakers to coordinate a COVID-19 response is awe-inspiring, and we as data scientists are happy to be able to support those on the front-lines.
However, data scientists can only help if we have access to data that is often considered proprietary. Given the current drive for collaboration, we wonder whether industry norms on data sharing will change after this pandemic.
We also believe it is absolutely vital to engage low- and middle-income countries when thinking about therapies. A lot of the coverage in the media has been directed at North America, Europe and China. We have a responsibility to create therapies that are accessible to everyone.
To that end we also hosted a virtual panel on May 7 with Nobel prize winner James Orbinski; Derek Angus of the University of Pittsburgh; and Trevor Mundel, who is currently President of the Bill & Melinda Gates Foundation; to discuss how the private sector can build partnerships in emerging economies. To view the recorded webinar, please visit https://bit.ly/2zeQq89.