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While preclinical research answers basic questions about a drug's safety, it is not a substitute for studies of ways the drug will interact with the human body. 'Clinical research' refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.

On this page you will find information on:

• Designing Clinical Trials

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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 https://saildownload.mystrikingly.com/blog/usb-not-working-macbook-air.

• 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

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

Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

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.

Phase 1 studies are closely monitored and gather information about how a drug interacts with the human body. Researchers adjust dosing schemes based on animal data to find out how much of a drug the body can tolerate and what its acute side effects are.

As a Phase 1 trial continues, researchers answer research questions related to how it works in the body, the side effects associated with increased dosage, and early information about how effective it is to determine how best to administer the drug to limit risks and maximize possible benefits. https://findagoo.weebly.com/connecting-hp-wireless-printer-to-macbook-pro.html. This is important to the design of Phase 2 studies.

Approximately 70% of drugs move to the next phase

Study Participants:Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. Typically involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial.

Instead, Phase 2 studies provide researchers with additional safety data. Researchers use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.

Approximately 33% of drugs move to the next phase

Study Participants:300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Affinity photo beta 1 7 0 116. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.

Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects

Approximately 25-30% of drugs move to the next phase

Study Participants: Several thousand volunteers who have the disease/condition

Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring

Learn more about Clinical Trials.

The Investigational New Drug Process

Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.

In the IND application, developers must include:

• Animal study data and toxicity (side effects that cause great harm) data

• Manufacturing information

• Clinical protocols (study plans) for studies to be conducted

• Data from any prior human research

• Information about the investigator

Asking for FDA Assistance

How to change profile picture on ao3. Drug developers are free to ask for help from FDA at any point in the drug development process, including:

• Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research

• After Phase 2, to obtain guidance on the design of large Phase 3 studies

• Any time during the process, to obtain an assessment of the IND application

Even though FDA offers extensive technical assistance, drug developers are not required to take FDA's suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.

FDA IND Review Team

The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.

• Project Manager: Coordinates the team's activities throughout the review process, and is the primary contact for the sponsor.

• Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.

• Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.

• Pharmacologist: Reviews preclinical studies.

• Pharmakineticist: Focuses on the drug's absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.

• Chemist: Evaluates a drug's chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.

• Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.

Approval

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

• Approval to begin clinical trials.

• Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:

  • Participants are exposed to unreasonable or significant risk.

  • Investigators are not qualified.

  • Materials for the volunteer participants are misleading.

  • The IND application does not include enough information about the trial's risks.

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.

The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.

This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

Studies 1 5 3 Commentary

Definitions

Major depression is one of the most common mental disorders in the United States. For some individuals, major depression can result in severe impairments that interfere with or limit one's ability to carry out major life activities.

Additional information can be found on the NIMH Health Topics page on Depression.

The past year prevalence data presented here for major depressive episode are from the 2017 National Survey on Drug Use and Health (NSDUH). The NSDUH study definition of major depressive episode is based mainly on the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5):

• A period of at least two weeks when a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration, or self-worth.
• No exclusions were made for a major depressive episode symptoms caused by medical illness, substance use disorders, or medication.

Prevalence of Major Depressive Episode Among Adults

• Figure 1 shows the past year prevalence of major depressive episode among U.S. adults aged 18 or older in 2017.
  • An estimated 17.3 million adults in the United States had at least one major depressive episode. This number represented 7.1% of all U.S. adults.
  • The prevalence of major depressive episode was higher among adult females (8.7%) compared to males (5.3%).
  • The prevalence of adults with a major depressive episode was highest among individuals aged 18-25 (13.1%).
  • The prevalence of major depressive episode was highest among adults reporting two or races (11.3%).

Figure 1

*All other groups are non-Hispanic or Latino | **NH/OPI = Native Hawaiian / Other Pacific Islander | ***AI/AN = American Indian / Alaskan Native

Major Depressive Episode with Impairment Among Adults

• In 2017, an estimated 11 million U.S. adults aged 18 or older had at least one major depressive episode with severe impairment. This number represented 4.5% of all U.S. adults.
• Figure 2 shows overall past year prevalence of major depressive episode with and without severe impairment. Of adults with major depressive episode, 63.8% had severe impairment.

Figure 2

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

• Approval to begin clinical trials.

• Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:

  • Participants are exposed to unreasonable or significant risk.

  • Investigators are not qualified.

  • Materials for the volunteer participants are misleading.

  • The IND application does not include enough information about the trial's risks.

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.

The developer is responsible for informing the review team about new protocols, as well as serious side effects seen during the trial. This information ensures that the team can monitor the trials carefully for signs of any problems. After the trial ends, researchers must submit study reports.

This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

Studies 1 5 3 Commentary

Definitions

Major depression is one of the most common mental disorders in the United States. For some individuals, major depression can result in severe impairments that interfere with or limit one's ability to carry out major life activities.

Additional information can be found on the NIMH Health Topics page on Depression.

The past year prevalence data presented here for major depressive episode are from the 2017 National Survey on Drug Use and Health (NSDUH). The NSDUH study definition of major depressive episode is based mainly on the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5):

• A period of at least two weeks when a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration, or self-worth.
• No exclusions were made for a major depressive episode symptoms caused by medical illness, substance use disorders, or medication.

Prevalence of Major Depressive Episode Among Adults

• Figure 1 shows the past year prevalence of major depressive episode among U.S. adults aged 18 or older in 2017.
  • An estimated 17.3 million adults in the United States had at least one major depressive episode. This number represented 7.1% of all U.S. adults.
  • The prevalence of major depressive episode was higher among adult females (8.7%) compared to males (5.3%).
  • The prevalence of adults with a major depressive episode was highest among individuals aged 18-25 (13.1%).
  • The prevalence of major depressive episode was highest among adults reporting two or races (11.3%).

Figure 1

*All other groups are non-Hispanic or Latino | **NH/OPI = Native Hawaiian / Other Pacific Islander | ***AI/AN = American Indian / Alaskan Native

Major Depressive Episode with Impairment Among Adults

• In 2017, an estimated 11 million U.S. adults aged 18 or older had at least one major depressive episode with severe impairment. This number represented 4.5% of all U.S. adults.
• Figure 2 shows overall past year prevalence of major depressive episode with and without severe impairment. Of adults with major depressive episode, 63.8% had severe impairment.

Figure 2

Treatment of Major Depressive Episode Among Adults

• Figure 3 shows data on treatment received within the past year by U.S. adults aged 18 or older with major depressive episode. Treatment types include health professional only, medication only, and health professional and medication combined.
  • An estimated 65% received combined care by a health professional and medication treatment.
  • Treatment with medication alone was least common (6%).
  • Approximately 35% of adults with major depressive episode did not receive treatment.

Figure 3

Prevalence of Major Depressive Episode Among Adolescents

• Figure 4 shows the past year prevalence of major depressive episode among U.S. adolescents in 2017.
  • An estimated 3.2 million adolescents aged 12 to 17 in the United States had at least one major depressive episode. This number represented 13.3% of the U.S. population aged 12 to 17.
  • The prevalence of major depressive episode was higher among adolescent females (20.0%) compared to males (6.8%).
  • The prevalence of major depressive episode was highest among adolescents reporting two or more races (16.9%).

Figure 4

*All other groups are non-Hispanic or Latino / **AI/AN = American Indian/Alaska Native

Studies 1 5 3 0

Major Depressive Episode with Impairment Among Adolescents

• In 2017, an estimated 2.3 million adolescents aged 12 to 17 in the United States had at least one major depressive episode with severe impairment. This number represented 9.4% of the U.S. population aged 12 to 17.
• Figure 5 shows overall past year prevalence of major depressive episode with and without severe impairment among U.S. adolescents. Of adolescents with major depressive episode, approximately 70.77% had severe impairment.

Figure 5

Treatment of Major Depressive Episode Among Adolescents

• Figure 6 shows data on treatment received within the past year by U.S. adolescents aged 12-17 with major depressive episode in 2017. Treatment types included health professional only, medication only, and combined health professional and medication.
  • An estimated 19.6% received care by a health professional alone, and another 17.9% received combined care by a health professional and medication treatment.
  • Treatment with medication alone was least common (2.4%).
  • Approximately 60.1% of adolescents with major depressive episode did not receive treatment.

Figure 6

Data Sources

Statistical Methods and Measurement Caveats

Diagnostic Assessment:

• For the NSDUH survey — no exclusions were made for a major depressive episode symptoms caused by medical illness, substance use disorders, or medication.
• For the NSDUH survey, methodology developed prior to the 2013 publication of the current DSM-5 was used to facilitate year-to-year comparisons.
• The adult and adolescent questions were adapted from the depression module in the National Comorbidity Survey Replication (NCS-R). Revisions to the questions in the modules were made primarily to reduce their length and to modify the NCS-R questions, which are interviewer-administered, to the audio computer-assisted self-interviewing (ACASI) format used in NSDUH. In addition, some revisions, based on cognitive testing, were made to improve comprehension. Furthermore, even though titles similar to those used in the NCS-R were used for the NSDUH modules, the results of these items may not be directly comparable. This is mainly due to differing modes of administration in each survey (ACASI in NSDUH vs. computer-assisted personal interviewing in NCS-R), revisions to wording necessary to maintain the logical processes of the ACASI environment, and possible context effects resulting from deleting questions not explicitly pertinent to major depression.
• Some questions in the adult depression module differ slightly from questions in the adolescent depression module; as such, major depressive episode data for adults aged 18 or older should not be compared to or combined with major depressive episode data for youths aged 12 to 17.
• The Sheehan Disability Scale (SDS) was used to assess the impact of major depressive episode on a person's life. The SDS is a brief self-report tool with ratings from 0 to 10 (with 10 being the highest) for the level of impairment caused by the disorder in each of four role domains: home management, work, close relationships with others, and social life. A rating of ≥7 in at least one domain is considered to be severe impairment. Respondents were excluded if SDS role impairment severity was unknown, or if particular activities listed in the SDS were not applicable. For SDS level of impairment, the role domains for adolescents aged 12 to 17 were slightly modified from those for adults to be made age appropriate.

Population:

• The entirety of NSDUH respondents for the major depressive episode estimates is the civilian, non-institutionalized population aged 12-17 (adolescents) and 18 years old or older (adults) residing within the United States.
• The survey covers residents of households (persons living in houses/townhouses, apartments, condominiums; civilians living in housing on military bases, etc.) and persons in non-institutional group quarters (e.g., shelters, rooming/boarding houses, college dormitories, migratory workers' camps, and halfway houses).
• The survey does not cover persons who, for the entire year, had no fixed address (e.g., homeless and/or transient persons not in shelters); were on active military duty; or who resided in institutional group quarters (e.g., correctional facilities, nursing homes, mental institutions, long-term hospitals).
• Some adults and adolescents in these excluded categories may have had a major depressive episode in the past year, but they are not accounted for in the NSDUH major depressive episode estimates.

Survey Non-response:

• In 2017, 32.9% of the selected NSDUH sample did not complete the interview.
• Reasons for non-response to interviewing include: refusal to participate (23.1%); respondent unavailable or no one at home (5.0%); and other reasons such as physical/mental incompetence or language barriers (4.8%).
• Adults and adolescents with major depressive episode may disproportionately fall into these non-response categories. While NSDUH weighting includes non-response adjustments to reduce bias, these adjustments may not fully account for differential non-response by mental illness status.

Please see the 2017 National Survey on Drug Use and Health Methodological Summary and Definitions report for further information on how these data were collected and calculated.

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