In these unprecedented times, with the world gripped by the Covid-19 pandemic, all eyes are on Big Pharma to find vaccines and therapeutics.
In her presentation for last week’s virtual OCT West Coast conference, GlobalData’s global director for databases and analytics Revati Tatake broke down pharma’s response to the Covid-19 pandemic and the impact the virus had on the industry and clinical trials over the past year.
New trials: pharma’s response to Covid-19
Pharma companies have been working tirelessly to develop vaccines and medicines to treat Covid-19, a virus that has spread to 194 countries and killed almost 2.5 million people.
As can be seen in the infographic below, the United States has suffered the most confirmed cases worldwide, followed by India and Brazil.
Several Covid-19 vaccines have been approved for emergency use by various regulatory authorities, and the clinical pipeline is crowded with over 1,000 vaccines and drugs in development for this new indication.
There are currently 397 therapeutics for Covid-19 in the discovery phase and 573 in the preclinical phase.
The same is true for Covid-19 vaccine candidates. While the first generation of vaccines is now rolling out under emergency use authorisations, a huge number of vaccine candidates are still in the discovery or preclinical stages, with 95 in the discovery phase and 274 in the preclinical phase.
With so many drugs in the pipeline, the clinical investigations continue to increase. There are over 4,000 Covid-19 trials that are either planned, ongoing or completed, of which over 1,800 have industry involvement.
Covid-19 trials are taking place worldwide but some countries are leading the way. The number of trials in the US and India have been growing at a much faster rate than anywhere else.
China started with the most trials at the the pandemic’s outset but the number of trials in the US surpassed China in June and continued to rise quickly, reaching 793 as of 8 February 2021. Since May 2020, clinical trials in India have increased dramatically with the country looking like it will soon surpass China in total number of trials conducted.
The increased clinical trial activity in the USA and India is consistent with the high number of Covid-19 infections in these two countries.
Impact of Covid-19 on trials
The Covid-19 pandemic has created a massive global effort centred around finding effective therapeutics and vaccines but because of these shifted priorities, non-Covid drug development programmes have had to take a temporary backseat or have been significantly impacted.
To understand the factors impacting the overall pharmaceutical value chain, GlobalData conducted a survey gauging the opinions of 198 respondents.
Impact on drug development and clinical trials was the top concern and the supply chain was ranked second.
Sales and marketing and manufacturing were seen as the least concerning factors impacted by Covid-19.
With clinical trials and supply chains being the top concerns, GlobalData analysed the survey data for supply chain concerns specifically for clinical trials material.
The company carried out two additional surveys to understand the issue better. The first was conducted in Q1 soon after Covid-19 was declared a pandemic in March 2020 and the second was conducted in Q3.
Logistics and transport issues were the largest concern in Q1, but dropped to one of the lowest concerns in the Q3 survey. The same was the case for non-API raw material which was of relatively high concern in the Q1 survey but significantly dropped in Q3. By contrast, API intermediates represented the lowest concern in Q1 but concern significantly shot up in the Q3 survey.
From GlobalData’s extensive surveys, clinical trial disruption came out as the primary business concern at 26%. This was followed by concerns regarding the safety of patients recruited in trials and employees involved in them, at 19 percent%. These concerns may have been driven by social distancing requirements and the initial global shortage of personal protective equipment.
Looking at concerns around clinical trials specifically, the inability to initiate clinical trials (or delays in trial initiation) was the highest at 30%, followed by the impact on trial participants at 26%. This could be due to the impact on sites or investigators’ ability to recruit participants. The safety of patients was the third most pressing concern, which could be down to the perceived risk of contracting the virus at trial sites.
GlobalData has been tracking trials that have been disrupted due to Covid-19. The chart below shows the ongoing disruption of clinical trials where several ongoing and planned trials were disrupted.
The most intense disruption was between April and mid-May 2020. Trial disruption peaked around June 2020 and since then there has been a slow but progressive decline in Covid-19’s impact. However over 1,000 trials continue to be disrupted due to the pandemic, according to Tatake.
Reasons for the disruption of clinical trials include delays in initiation of planned trials, as well as temporary suspension of recruitment, and overall slow recruitment, in ongoing trials.
Although initially the majority of trials were disrupted due to temporary suspension of recruitment, the suspended trials began to recruit more participants in mid-2020 as reflected by the downward trajectory in the pandemic’s impact.
However, delays to trial initiation and slow recruitment continues. In fact, trials experiencing slow recruitment continue to rise.
By therapy area, oncology trials continue to suffer the most as a result of Covid-19 disruption, followed by trials in central nervous system diseases. This could be down to the fact that there are significantly more ongoing trials in these therapeutic areas than any other indications.
In terms of trial disruptions relative to the overall recruiting and planned trials, haematological disorders had the highest proportion of disrupted trials, closely followed by gastrointestinal trials. Relatively speaking, oncology trials are proportionately less affected, and the infectious disease area had the least disrupted trials, as many trials in this area are for Covid-19 vaccines and therapies.
Regionally, North America had the lion’s share of trial disruption at 60 percent, followed by Europe at 42 percent and the Asia Pacific region at 21 percent. At a country level, the US had the most trials disrupted, followed by the UK and Spain.
With all of this disruption, how is this going to impact the regulatory approval of some drugs? As can be seen in the chart below, 18% of the currently disrupted trials are pivotal or those for registration of the drugs being investigated. This may indicate a substantial negative impact on non-Covid-19 regulatory approvals that are dependent on these trials. Among these the most affected trials are for oncology indications followed by those for cardiovascular diseases.
There is also some good news. Trial activity has started to resume after a period of disruption due to Covid-19. Many trials have started recruiting subjects while some have completed recruitment and are still ongoing for the trial readout. The most trials that have resumed are for oncology and central nervous system diseases.
Click here to find out more about the post-pandemic outlook for clinical trials from Revati Tatake’s presentation at OCT West Coast.