Clinical Trial Timelines

Extracted Attributes

• Estimated Cost

  Billions of dollars (measures total investment per approved drug)

• Phase 1 Duration

  Several months (measures initial safety and dosage testing)

• Phase 2 Duration

  Several months to 2 years (measures effectiveness and safety in larger groups)

• Phase 3 Duration

  1-4 years (measures efficacy and comparative safety)

• Approval Success Rate

  10 percent (measures the percentage of drugs entering human trials that receive approval)

• Average Total Duration

  7-15 years (measures time from discovery to drug approval)

• Discovery Phase Duration

  3-6 years (measures pre-clinical investigation and animal trials)

• Phase 1 Participant Count

  20 to 100 volunteers (measures sample size for safety trials)

• Phase 2 Participant Count

  100 to 300 volunteers (measures sample size for effectiveness trials)

• Phase 3 Participant Count

  300 to 3,000+ volunteers (measures sample size for large-scale efficacy trials)

Timeline

• The FDA (participant) updates clinical research guidelines to standardize drug development (cause), establishing typical durations and participant counts for Phase 1, 2, and 3 trials (consequence). (Source: Web Search Result: Step 3: Clinical Research - FDA)

  2018-04-03

• Marty Makary (participant) announces FDA reforms at the JP Morgan Healthcare Conference in San Francisco to counter Chinese biotech competition (cause), proposing to reduce pivotal trials and adopt computational modeling to shorten timelines (consequence). (Source: Document 065d2e96-4d40-49bd-8511-d8d35f8b01f4)

  2025-01-13

Clinical trial

Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results. Costs for clinical trials can range into the billions of dollars per approved drug, and the complete trial process to approval may require 7–15 years. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical-device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. Only 10 percent of all drugs started in human clinical trials become approved drugs.

Web Search Results

• How long do clinical trial phases take? - Antidote.me

  Even before reaching the clinical trial stage, there are other types of medical research that go into discovering new therapies. All research begins in the discovery phase, which is the three to six years that involves investigating new ideas, followed by animal trials. After these two phases are done, a potential treatment is able to enter the first phase of clinical trials with human participants. ### How long do clinical trial phases take? Different phases of clinical trials fulfill different purposes, but all are designed to test potential treatments in groups of individuals until they are deemed both safe and effective. The typical clinical trials timeline is as follows: [...] Phase 1: Phase 1 of a clinical trial will typically be open to 20 and 100 participants, and will last for several months. This phase is not intended to evaluate whether the treatment in question is effective — instead, the purpose of this phase is to measure safety by checking for adverse side effects. Phase 1 trials typically look for healthy volunteers, but may seek people with the condition being studied depending on the type of research in question. Phase 2: Once a drug has been deemed safe from the Phase 1 results, it is able to progress to Phase 2. Around 70% of drugs progress to the second phase, which is designed to measure safety in a larger group of volunteers (typically several hundred), while also measuring the effectiveness of the treatment on the participants. [...] Phase 3: About 33% of drugs will make it past the second phase and go on to Phase 3. The third phase of a clinical trial recruits the largest number of participants, with enrollment goals typically in the thousands. Phase 3 is intended to measure both safety and efficacy for a longer duration, usually lasting between one and four years. FDA Approval: After a treatment has passed Phase 3, the sponsor of the study will submit a New Drug Application (NDA) or a biologics license application (BLA) to the Food and Drug Administration (FDA). The FDA will review all the information the researchers gathered during each stage of the trial to determine if the drug will be approved.

• Phases of Clinical Trials - MD Anderson Cancer Center

  Patients can usually stay on a Phase I clinical trial as long as they benefit. A traditional Phase I clinical trial lasts about two years (from the time we start enrolling to the time that we actually close out a study). What happens if a patient’s condition doesn’t improve? [...] Share this article Via social media: Or copy the link: # Phases of Clinical Trials A new treatment goes through several phases. Each phase has a different purpose: Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment. Phase II trials test if one type of cancer responds to the new treatment. Phase III trials test if a new treatment is better than a standard treatment. Phase IV trials find more information about long-term benefits and side effects. Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not. [...] Phase I trials usually include 15 to 50 patients who are divided into small groups. These groups are called cohorts. The first cohort receives a dose of the new drug. Doctors may collect blood or urine samples to measure drug levels in the patients. If the first cohort does not have any severe side effects, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the doctors find the best dose for future testing. With each increasing dose, doctors test each patient to see if he or she is responding to the treatment. If the doctors find that the treatment is safe, then it will move forward to be studied in a Phase II trial.

• Step 3: Clinical Research - FDA

  Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies. What are the Clinical Trial Phases? Watch this video to learn about the three phases of clinical trials. Clinical Research Phase Studies Phase 1 Image 5 Study Participants:20 to 100 healthy volunteers or people with the disease/condition. Length of Study:Several months Purpose:Safety and dosage During Phase 1 studies, researchers test a new drug in normal volunteers (healthy people). In most cases, 20 to 80 healthy volunteers or people with the disease/condition participate in Phase 1. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer. [...] Designing Clinical Trials Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide: Who qualifies to participate (selection criteria) How many people will be part of the study How long the study will last Whether there will be a control group and other ways to limit research bias How the drug will be given to patients and at what dosage What assessments will be conducted, when, and what data will be collected How the data will be reviewed and analyzed

• How long do clinical trials take?

  ### How Long Does a Phase 3 Clinical Trial Take? The length of study for phase 3 clinical trials is usually 1 to 4 years. This phase involves 300 to 3,000 patients, with tests designed to determine the drug's longer-term effects. ### How Long Does a Phase 4 Clinical Trial Take? The length of study for phase 4 clinical trials can be the same as that for a phase 3 clinical trial or even longer. Read more about the phases of clinical trials. ## THE RIGHT TO WITHDRAW AT ANY TIME Participation in a clinical trial is completely voluntary, so you have the right to withdraw from the clinical trial at any time, for any reason. [...] ## HOW FAST DO CLINICAL TRIALS WORK? Clinical trials are not a guaranteed solution to disease. The length of a clinical trial generally increases with each clinical trial phase; phase 3 clinical trials are typically longer than phase 2 clinical trials. ### How Long Does a Phase 1 Clinical Trial Take? The length of a phase 1 study is typically several months. ### How Long Does a Phase 2 Clinical Trial Take? The length of a phase 2 study can span several months to 2 years. This phase involves up to several hundred people, with researchers looking for the effectiveness and safety of the drug over a relatively short period of time. ### How Long Does a Phase 3 Clinical Trial Take? [...] If you do stop your participation for any reason, you will continue to receive care and advice on your treatment options. You will be asked to return for a final evaluation by the trial doctor, which may include a physical examination and/or laboratory tests. References: Step 3: Clinical Research. U.S. Food & Drug Administration website: Accessed April 3, 2018. ### SEARCH ACTIVE TRIALS To read about clinical research for a specific health condition, or to search by disease area, please view the list of active clinical trials. abbvie-logo AbbVie Clinical Trials is designed to support, inform, and help patients in a clinical study or those who are interested in participating.

• The Basics | National Institutes of Health (NIH)

  Phase I trials: Researchers test a drug or treatment in a small group of people (20–80) for the first time. The purpose is to study the drug or treatment to learn about safety and identify side effects. Phase II trials: The new drug or treatment is given to a larger group of people (100–300) to determine its effectiveness and to further study its safety. Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments, and collect information that will allow the new drug or treatment to be used safely. [...] #### Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions.