Last week Cytel launched a COVID-19 Trial Tracker, an Open Access tool to track the global response to the coronavirus pandemic. This central repository of clinical trials will be updated daily to ensure that all new scientific findings can be easily identified on a single website.
While early results are still coming in, there are already important insights we can glean about the current state of research from the COVID-19 Trial Tracker. Delving deeper into these insights results in important new questions about global cooperation for clinical development.
The following details are based on an updated data search up until April 8th
Total Registered Trials
There are currently over 535 registered interventional trials worldwide which include 94 for either chloroquine or hydroxychloroquine (though only 42 are currently enrolling), 48 for lopinavir/ritonavir, 28 using stem cell therapies, 23 for interferon therapies, 21 for plasma based therapies and 21 for tocilizumab.
The Clinical Trial Tracker shows that 12 trials have completed thus far (though not all have shared results):
- 9 in China
- 2 in Iran
- 1 in France
Two of these were double-blinded.
Trials Recruiting and Non-Recruiting
Across all trials, recruiting and non-recruiting, 324,000 participants are anticipated to be recruited into COVID-19 interventional studies. An additional 275 trials have begun to recruit participants. About 130,000 participants would have to be recruited to complete these trials. As of April 8, 1.5 million patients have been tested positive for COVID-19 so 130,000 patients accounts for about 10% of the entire population.
Trials in the United States
Currently, 22 out of 52 trials including participants in the USA have begun to enroll. These will need to enroll an estimated 18,900 participants to complete all of the trials. A central question then becomes how to enroll this number of participants without affecting an already over-burdened healthcare system. A separate but equally important question is how to determine whether to prioritize the most promising therapies, and ensure that patients enroll into those first.
Trials for Chloroquine and Hydroxychloroquine
Currently there are 42 trials actively enrolling participants to be treated with either chloroquine or hydroxychloroquine as part of a therapeutic arm either alone or in combination. Completing all of these trials will require the recruitment of over 47,300 individuals.
Challenge 1: Reaching Recruitment Targets through Advanced AnalyticsHow can countries cooperate to ensure that patients are not being unnecessarily tested and that meta-analysis is performed quickly and correctly?
Clearly one of the main challenges in finding a cure to the COVID-19 pandemic involves reaching recruitment targets, given that tens of thousands of patients will have to enroll before trials complete. This would be a singular achievement even if the healthcare system was not overburdened. In the current climate a number of strategies using advanced analytics capabilities will need to be employed.
A variety of strategies can be used to achieve recruitment targets specifically, or even to alleviate the need for such recruitment. For example, given that there are currently 42 trials actively enrolling for chloroquine or hydroxychloroquine, there might be opportunities to aggregate data across these trials to determine safety and effectiveness.
As data increases, simulation and forecasting techniques can be implemented to create external arms across datasets, leading to lower recruitment targets. Master protocols have already been designed and implemented to ensure that the most is made from every data point collected by scientists.
Challenge 2: Expedited Trials Using Complex Innovative Designs & Real World Evidence
The rising number of COVID-19 cases also makes clinical development in this space ripe candidates for the use of real world evidence. Single arm trials with high statistical rigor are possible in such situations. Dynamic borrowing from previous trials using validated Bayesian methods can simulate enrollment without need to use scarce patients. Large national and international registries are emerging, and data on important prognostic factors are developing on a daily basis.
Perhaps the most important element in finding a solution to the pandemic is achieving effective treatment while accounting for the slow speed of most clinical trials. Unplanned adaptations with countless interim looks might expedite the process of finding the cure.
Cytel’s COVID-19 Trial Tracker aims to help scientists, policy-makers and philanthropists identify promising treatments quickly, to ensure that patients available for testing are channeled towards the right trials. The trials currently enrolling are early phase trials for the most part. Larger Phase 2 and 3 trials will be necessary before a therapy becomes trustworthy.
Cytel believes that data scientists have an important role to play in ensuring that every element of data collected is put to good use to build models, make reasonable predictions, and seek out the research questions that will guide enquiry. Cytel is fully committed to helping make this possible.