What is Required of Drug Safety During the COVID-19 Pandemic?


Applied Clinical Trials

While research and development across the world rushes to provide treatments and vaccines for COVID-19, the industry has a responsibility to ensure they are both safe and effective, writes Andrew Rut.

The COVID-19 pandemic represents one of the most significant global healthcare challenges of our generation. Within the pharma industry we are privileged to be in a position to be part of the solution. However, while R&D across the world rushes to provide treatments and vaccines for COVID-19, we have a responsibility to ensure they are both safe and effective. It is essential to ensure the safety profiles of these potential therapies are supported by robust data, so that healthcare providers and physicians can make appropriate, evidence-based decisions for their patients.

As the industry moves from small formal clinical trial phases rapidly into real world evidence programs, I believe that Large Simple Trials will be utilized increasingly to provide evidence in a robust way across large populations. These trials are particularly suited when the population exposed to the risk is heterogeneous, and when several risks of differing magnitude need to be assessed in the same trial,all of which apply to COVID-19 populations. With a new disease such as COVID-19, we lack understanding of both the intrinsic (genetic) and extrinsic (lifestyle, medicines etc.) factors that impact an individual’s immune response to the pathogen as well as their response to treatments.  

The timescales to develop novel medicines or vaccines are lengthy (even with the current laser-focus), so industry is repurposing existing medicines to speed the process. The good news is we are already seeing recruitment of large numbers of patients into trials to assess potential impact of existing medications in COVID-19. For example, the RECOVERY trialis currently assessing four different treatment options initially, with an adaptive design that enables inclusion of additional treatments as required. It has recruited over 1,000 patients across more than 130 hospitals in the UK within just 15 days.  

Of course, assessing the benefit-risk profiles of COVID-19 specific treatments in isolation will not provide the breadth of information necessary to make truly informed clinical decisions. A large percentage of the global population are taking regular medication for chronic diseases such as diabetes, hypertension, or asthma. The question that we need to answer is “does this disease population and the associated medicines carry a different risk profile when exposed to COVID-19 compared to a healthy cohort?” The population impact of differential risk could be huge given that around 15% of people in just the UK take anti-hypertensive medicines. Some in the medical community believe that patients on angiotensin receptor antagonists or angiotensin receptor blockers have a higher risk of progression to severe and fatal COVID-19.Others consider the benefits outweigh the risk, so patients should continue their usual treatment.Right now, we need sufficient data across populations with these chronic conditions to understand the variation in risk profile of both COVID-19 itself, and any associated treatments. 

Adding to this, evidence is now emerging that genetics plays a role in the susceptibility, progression and the impact of intervention on COVID-19.Research programs aim to compare the genetic profiles of individuals who have suffered serious cases of COVID-19 with no other risk factors-with those with mild or no disease. One such study is GenOMICC,that originally focused on other emerging infections (SARS/MERS/Flu) and has now been adapted to include COVID-19 patients. 

It is imperative that our evidence base enables researchers to account for risk and confounding factors accurately. Failure to do this leads to three potential issues: providing ineffective medicines to a large population, providing effective medicines that also cause significant harm when given to large populations, or-in the worst scenario-providing ineffective medicines that also cause significant harm to populations. It is only through systematic capture of large appropriately powered, standardized data sets that we will build the body of evidence required to make informed clinical decisions on the appropriate medicines to prevent and treat the different stages of COVID-19.

This is where Large Simple Trials can assist the research community. They benefit from a study design and a study protocol to provide large datasets in an intelligent, structured way for robust analysis while also facilitating speed through virtual conduct. This enables physicians and other healthcare professionals to enroll patients under their care and manage subject participation without a bureaucratic overhead. Large Simple Trials also offer the flexibility to allow researchers to apply adaptive designs and update protocols to include new treatment options as they begin to show promise elsewhere.  

One of the challenges of capturing data on the safety of all medicines during a pandemic is that it must be captured in a way that ensures robust, accurate data and rapid transmission to the safety teams conducting analysis. Previously, capturing data posed many challenges due to reliance on manual processes, with call centers, emails, and even faxes coming into them. Now, with digital technology, the reliance on human processing can be removed and structured data can be collected direct from source. Physicians, patients, or caregivers can utilize applications at the bedside and send reports direct to pharmacovigilance teams. This is key as empowering patient reporting, particularly during large post-approval surveillance programs provides pharma the opportunity to gather a valuable perspective on the safety profile of its medicines.

Not only does technology streamline the process, it can also elicit truer responses from patients, particularly regarding sensitive aspects of their lifestyle which could include use of recreational drugs that may well influence susceptibility to COVID-19. Indeed, a study by USC suggests patients are more willing to disclose personal information to virtual humans than actual ones, in large part because computers lack the proclivity to look down on people the way another human might.7

As an industry, we’re privileged to be in a position where we can make a material difference to the spread of COVID-19 and impact the lives of millions of people around the world. Our contract with patients is to act with honesty, transparency, and integrity and provide their healthcare professionals with medicines that are supported by real evidence. It is only then that the healthcare system we serve can trust what we do, believe in the treatments we deliver, and make the best possible decisions for their patients.


Andrew Rut, MD is the  Founder and CEO of MyMeds&Me



  1. http://www.encepp.eu/standards_and_guidances/methodologicalGuide4_4_2.shtml
  2. https://www.recoverytrial.net/
  3. https://www.thelancet.com/pdfs/journals/lanres/PIIS2213-2600(20)30116-8.pdf
  4. https://jamanetwork.com/journals/jama/fullarticle/2763803
  5. https://www.sciencemag.org/news/2020/03/how-sick-will-coronavirus-make-you-answer-may-be-your-genes
  6. https://genomicc.org/
  7. https://news.usc.edu/65051/patients-are-more-willing-to-confide-in-computers-not-doctors-usc-study-suggests/
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