The Drug Development Process

A treatment only becomes available to the community after a long and complex process involving several steps. The potential treatment must be identified and tested in cell or animal models prior to testing in humans through clinical trials. Regulatory agencies review the potential treatment at several steps along the process. On average, this process takes 12 to 15 years. You can learn more about this process by clicking the button below.

Stages of Drug Development
diagram to illustrate clinical trial stages

Phases of Clinical Trials

There are typically three phases of clinical trials that differ in specific goals and number of participants.  All phases of clinical trials aim to investigate the safety of a potential treatment in humans and phase 2 and 3 trials evaluate the effectiveness of a therapeutic. After approval by a regulatory agency, data on long term efficacy and safety is collected in post-marketing studies, sometimes called phase 4 clinical trials. Click below to learn about currently enrolling trials or to access the glossary to help you understand clinical trial terms.

diagram of clinical trials phases

Clinical Trial Safety

There are several groups involved in monitoring the safety of a clinical trial through different processes. These include protocols set in place by the study sponsor as well as outside review agencies. The Clinical Trials 101 Guide for Participants contains an in-depth view of the ways safety is monitored in clinical trials.

Clinical Trials Participant Guide
people sitting around in hospital waiting room

Frequently Asked Questions and Clinical Trial Etiquette

Here are some other questions and topics to consider about clinical trials including what may be expected of you as a clinical trial participant.

A clinical trial investigates the safety and efficacy of a medical intervention, such as a drug or medical device, in humans. Typically, you cannot participate in more than one clinical trial at a time. A clinical study aims to make observations about a disease and does not test an experimental drug or device. Clinical studies often observe the natural history of a disease or investigate potential biomarkers. Usually, you can be involved in multiple clinical studies at the same time.

No. The clinical trial team is not able to provide clinical care such as starting the process for a new wheelchair during a clinical trial visit.

It’s okay to tell your friends and family that you’ve enrolled in a clinical trial. But, if the trial is blinded, don’t share how you think the drug or treatment is making you feel – even with the study site team. This can jeopardize the integrity of the research.

Each clinical trial will have a protocol that participants must adhere to – a list of rules to follow while enrolled in the study. You should make sure you understand these rules beforehand, including how many visits you must attend, tests that will be done, and other requirements you’ll be asked to fulfill. If you have a question about how to meet these requirements, call the study site.

Don’t be discouraged by logistical bumps in the road, and keep in mind that this is research. It might be the first time a specific test or other element of the study is being conducted, and your participation and patience contributes to the knowledge gained by the clinical trial. However, if something is not as you expected, it is always important to share your concerns with a member of the study team.