About

Drug Development Process

Clinical research trials are essential to the drug development process, which in and of itself is a lengthy, expensive, and complex undertaking.On average, bringing a new drug or medical device to market can take 15 years and cost as much as $1.2 billion.

The drug development process—involving discovery, pre-clinical research, clinical trials, and regulatory approval—requires a collaborative effort among the sponsor’s staff, regulators, physicians, academic researchers, and patients.

ACRO member companies contribute to all aspects of drug development with an emphasis on Phase I-IV clinical trials and related laboratory services. The drug development process is broken into several stages as outlined in the graphic below.

 

Pre-Clinical Research


1-3 years

Objective: Testing the drug on animals. Once these tests indicate the product is safe, human clinical trials begin.

PHASE 1 Initial Human Trials
6 months – 1 year

Objective: Testing the drug on 20 – 80 healthy individuals to determine the drug’s basic safety and pharmacological data.

PHASE 2 Expanded Human Trials
1 – 2 years
Objective: Testing the drug on around 100 – 200 patients who suffer from the disease or condition the drug is meant to address.

PHASE 3 a
2 – 3 years

Objective: Test the drug with several hundred to several thousand participants at a variety of sites to verify efficacy and safety on a larger scale, with a focus on regulatory issues.

Once complete, the drug’s sponsor submits all relevant data as well as plans for producing, packaging, and labeling to local regulatory agencies for review—which can take up to 30 months or more.

PHASE 3 b
6 months – 1 year

Objective: Testing the drug on large groups of patients for cost-effectiveness and efficacy compared with similar, approved drugs.

PHASE 4
Once a drug has received regulatory approval; ongoing

Objective: Address the safety and efficacy of uses beyond the drug’s original application, test different dosage strengths and formulations, and confirm extra-clinical benefits, such as cost-effectiveness or improved quality of life.