The Wheeler Institute supports Professor Chang’s new research: The COVID-19 Pandemic and Clinical Trial Disruptions
Saving Lives and Accelerating Innovation: Implications of the Expanded Access Programme in the Pharmaceutical Industry
Among many areas where the COVID-19 pandemic is having an effect, this research focuses on the effect of the pandemic on medical resource allocation. Due to the urgency and the pandemic’s immediate impact on patients, most medical resources are being reallocated toward Covid-19. While the eventual development of vaccines and treatment modalities will be universally impactful across the globe, the compromises being made for this resource allocation can affect people in developing countries, where people lack access to basic health system and drugs.
The pandemic is skewing the already uneven distribution of medical resources, with a disproportionate amount of drug development occurring in developed countries; this research will shed light on the status quo of the landscape of medical resources. This will include investigating the types of drugs and clinical trials being terminated or suspended due to the outbreak.
According to research, 440 clinical studies have been suspended or terminated due to the outbreak since 1st March 2020. This is also due to the slow accrual of patients, but it reflects the resource constraints faced by most pharmaceutical companies. Another example is Remdesivir, which is being developed by Gilead Sciences. Remdesivir was originally being developed for the Ebola virus, a disease that disproportionately affects the population in developing countries. However, Remdesivir is now being considered as a potential treatment option for Covid-19. As financial prospect is higher in developed countries, the fortune of Remdesivir may now reside through Covid-19 instead of the Ebola virus.
This research will scrutinize the effect of Covid-19 on the development paths of existing investigational products intended for people in developing countries. This will include investigating the drugs and clinical trials that have been terminated or suspended due to the outbreak. Through this research, we will be able to shed light on the effect of the pandemic across the globe and the subsequent implications.
The project will document evidence on the impact of Covid-19 on the development paths of existing investigational products and investigate:
- Are drugs that target diseases more prevalent in developing countries being affected to a greater extent;
- Are certain types of drug development more affected by the pandemic.
For instance, it would be reasonable to predict that the drugs that are preventive in nature (such as vaccines or cancer prevention) are more likely to be affected since it is not the pharma’s first priority. In addition, early-stage clinical trials such as Phase 1 and 2 are more likely to be affected for a similar reason. These affected areas can have large and significant long-term costs to the social welfare of developing countries.
inequality in terms of medical access is becoming stark. The Extended Access Programme means that pharmaceutical companies share their investigational drugs to patients in life-threatening situations, thereby using innovation to save lives. However, not many companies are using this programme. The lack of effective treatment is a huge social challenge for the world, especially in developing countries; we want to increase the extent to which pharmaceutical companies work with social entrepreneurs to increase the reach of drugs where they are needed in developing markets. We also want to use this research to help Governments and policymakers understand the constraints pharmaceutical companies are facing, as this will help create better public policy, business opportunities and save lives in developing countries.Professor Chang
Who is involved?
The “The Covid-19 Pandemic and Clinical Trial Disruptions: How Does the Covid-19 Pandemic Affect the Development of Drugs for the Lives in Developing Countries?” project is part of the Wheeler Institute COVID-19 Research Support. Please see here to learn more about our research support.
The Wheeler Institute is seeking to understand, illuminate and offer solutions to the challenges created by COVID-19. With an aim to identify the role of business in addressing these challenges and a focus on the implications and actions for those in developing countries. We are now offering a number of grants to members of the LBS academic community for new research on issues related to the current crisis.