Clinical trials are a critical stage in vaccine development, and during the Covid-19 pandemic we watched vaccines hurtle through the process at remarkable speed. However, vaccine development traditionally lasts a lot longer. So, what takes them so long?
In the European Union the EMA, a decentralised agency of the European Union operating since 1995, sees approximately 4,000 clinical trials. Of this figure, 60% are sponsored by the pharmaceutical industry and 40% non-industry sponsors, such as academia.
The EMA’s American sibling is the FDA, an agency within the Department of Health and Human Services. Even before a vaccine enters the clinical trial stages with the FDA an Investigational New Drug (IND) application must be submitted. In this application developers must present:
- Animal study data and toxicity
- Manufacturing information
- Clinical protocols
- Data from prior human research
- Information about the investigator
Once this initial stage has been achieved, a drug can enter the Phase stage. The rigorous trial process follows a similar pattern on both sides of the pond.
Clinical trials are an expensive process. Public health funding for clinical trials decreases every year, resulting in greater investment from the pharmaceutical industry. For example, in 2012 the NIH paid $31 billion for trials, whereas pharmaceutical companies contributed $8 billion more. Although reported to demonstrate systematic bias, trials that receive funding from the pharmaceutical industry are said to generate greater levels of evidence through higher numbers of patients. They are also published more easily in free-access journals, which increases the visibility of these trials.
After the success and efficiency of the Covid-19 vaccine trials, a false sense of optimism might be felt among the public, perhaps previously ignorant of the process. Of the 70% that proceed from Phase 1 to 2 in the United States only 33% move to Phase 3. From there, only 25-30% are launched into Phase 4. As more diseases appear or reappear, will we be able to respond with such a collective and collaborative approach that tests the limits of scientific efficiency, and what did we do during the pandemic to get things done?
