Coastal Research Associates, LLC

Americans spend more money on pharmaceuticals than neighboring Canada and Mexico, more than 20 European countries; and Japan, Korea and New Zealand. Billions of dollars are spent well before your medicine hits the pharmacy shelf – but where does all that money go? Read on to learn more about the drug development process and the work that goes into medicinal therapeutics.  

During this step, researchers focus on finding innovative new therapies through extensive testing and research. They begin with sometimes thousands of different options and whittle their way down to a few final options for further development.   

Once researchers have selected a unique compound mixture, they can begin to analyze the drug’s dosage, potency and side effects. Additionally, they look at the best methods of consuming or injecting the investigational drug, and its effectiveness compared to similar medications.

Before human testing can begin, researchers first must determine the toxicity of an investigational drug. Typically, mice or other small animals are utilized, depending on which animal has the most similar physical characteristics to humans. Once researchers have determined that an investigational drug is non-toxic for humans, they will recruit a small group of volunteers for initial testing.

There are four different phases of clinical research. These phases correspond to the overall length of study, patient volume and complexity of the research plan. As an investigational drug moves through the process, the overall volunteer group size exponentially increases, which is a significant reason why certain phases may take years to complete.  

The key objectives are to: 

1.Establish whether a medical product or device is safe for humans; 

2.Examine the way humans break down the experimental drug; 

3.Investigate the drug’s effectiveness and confirm which dosage is most effective; 

4.Determine which segments of the population experience the highest success rate; 

5.Identify any noted or potential side effects.

Many times, researchers will evaluate the wellbeing of a group of volunteers who receive an experimental medication against a “control group” who received a placebo (an inactive drug or substance that looks like the active drug). This is done to ensure statistically valid data and to help rule out alternative explanations for study results.

The Food and Drug Administration (FDA) has been reviewing drugs for over 100 years and just 10% of all drugs that start clinical trials will result in an approved drug. Their review process for all new medications is comprehensive and rigorous.  The FDA is ultimately the gatekeeper of the approval process. They oversee the drug development process and their policies and regulations impact every pharmaceutical company, clinical research and study volunteer in the industry. 

Post-marketing surveillance occurs after an experimental drug has been approved. These studies provide manufacturer’s with an opportunity to more closely examine the medication’s long-term side effects. Additionally, manufacturer’s may gain further insight into the long-term benefits of the treatment in a much larger patient population size, and the medication’s comparison against other treatments currently on the market.