The Drug Development Process

The Coronavirus crisis has affected almost every country on the planet, and there has never been more interest in the processes of developing drugs and vaccines. As case numbers continue to rise, and teams of dedicated scientists work around the clock to develop new treatments and create a vaccine, it’s fascinating to take a closer look at what is involved in the global effort to identify effective, safe remedies and preventative solutions. 

Image credit: https://pixabay.com/illustrations/corona-coronavirus-virus-blood-5174671/

COVID-19 drug development

In the last six months, millions of people have been affected by COVID-19. As reports of the virus emerged, and the number of infections grew exponentially, researchers all over the world set about trying to establish ways to treat the symptoms of the virus, reduce fatalities and shield populations in the future. Developing drugs is often a complex process, which involves taking a novel treatment and moving through rigorous evaluation and testing stages to reach a point where the drug is accessible to health professionals and patients. There is no set time frame, but in most cases, it takes 10-15 years to turn a new drug into a treatment that is widely available. 

 

Typically, the drug development process involves 5 key stages, including:

  1. Drug discovery
  2. Preclinical research
  3. Investigations into new drug application
  4. Clinical trials
  5. Regulation, approval and ongoing safety evaluation

 

To succeed in getting a drug to market, researchers must complete every phase. This is vital to ensure efficacy, but also to protect populations from side-effects, complications and risks. 

 

COVID-19 presents unique challenges for scientists and manufacturers, due to its prevalence, its impact and the risk of severe complications. 

The race to develop the first COVID-19 vaccine

As news headlines continue to be dominated by the COVID-19 crisis, audiences are waiting for news about a vaccine with bated breath. Since the genetic sequence for SARS-CoV-2 was published at the beginning of 2020, multiple research teams have been working tirelessly to develop a vaccine. There has been fervent activity, and already, we are seeing positive signs emerging. Usually, it takes several years to develop a vaccine, but unprecedented financial investment and scientific enterprise and expertise have contributed to the development of multiple vaccines, some of which are now undergoing human trials. 

 

The latest updates in the UK revealed positive signs in terms of efficacy, safety and side-effects, and it is hoped that progress will continue at lightning speed. The problem with vaccine development is that the road is often fraught with obstacles, and there is never a guarantee that a vaccine will work, even when countries are poised to benefit from the work of the world’s leading scientists. Teams across the globe are growing in confidence, but there is still a degree of uncertainty and only time will tell if the vaccines that are currently showing promise will pass the tests still to come. 

Barriers to vaccine and drug development

Every novel drug and vaccine presents challenges, and there are barriers to overcome. In the case of COVID-19 drug development and the search for a safe, effective vaccine that can be rolled out on a global scale, the most significant obstacle is time. Every day, the number of cases and deaths is rising, and it’s a race against the clock to find solutions that will halt the progress of the virus. COVID-19 hasn’t just claimed lives. It has also shattered economies and increased the risk of knock-on effects on mental and physical health crises in the months and years ahead. Time is of the essence, but unfortunately, there is no way of developing drugs or vaccines in a matter of days. Every stage of the process has to be completed to provide safe treatments. Vaccine development is a very complex science, and this particular mission is made all the more difficult by the fact that we are dealing with a novel and unpredictable enemy. 

Approval

Any drug or vaccine that is provided for patients must be approved for use by regulatory bodies, such as the FDA (US Food and Drug Administration) and the MHRA (Medicines and Healthcare Regulatory Agency). Approval indicates that treatments are safe to use and they meet the rigorous criteria set out by the authorities in the relevant country. If new treatments are developed for COVID-19, they will be approved by regulatory agencies before they are made available to patients. 

Clinical trials

Clinical trials are a vital element of the drug and vaccine development process. Trials are designed to answer specific, targeted questions raised by researchers. Trials must be planned meticulously to ensure that participants are protected and that data is accurate and reliable. There are various stages involved in clinical trials. Initially, trials usually involve a small number of people. During the latter stages of the trial, numbers will increase significantly and the pool of participants will become more diverse. In the case of a COVID-19 vaccine, for example, teams working on vaccines that are showing promise will start by trialling their vaccine on a small group of healthy individuals. As the vaccine progresses through key stages of the clinical trial, numbers will rise steeply. Clinical trials are essential for evaluating responses to the vaccine and ensuring safety in the general population. 

Image from https://www.pexels.com/photo/person-holding-injection-3825529/

 

Summary

Drug development involves years of clinical research and trials before medicines are even considered for approval. As teams of the world’s leading scientists work flat out to develop a vaccine for COVID-19, the spotlight is firmly on research and development. With positive signs emerging, ministers, researchers, patients and healthcare professionals are eagerly awaiting news of a vaccine that works and is safe to use. The race is on, but there are challenges to overcome. Time is a monumental barrier, with case numbers growing by the day, and it’s not possible to take short-cuts. The vaccine and drug development process is complex and long-winded, and there’s no guarantee of a successful outcome.