Interventional Clinical Study

A Interventional Clinical Study is a prospective clinical study that is an intervention study (which attempts to assess the efficacy of a clinical investigational product).

• AKA: Therapeutic Treatment Trial.
• Context:
  • Input: Experimental Therapy.
  • Output: Clinical Research Intervention Study Data; Clinical Intervention Study Report.
  • It can (typically) attempt to determine whether a Clinical Intervention is safe, effective, and beneficial to patients.
  • It can (typically) be be managed by a Clinical Research Intervention Study Process.
  • It can (typically) be associated with a Clinical Trial Status, such as terminated clinical trial.
  • It can (typically) be formally described in a Clinical Research Intervention Study Protocol Document.
  • It can (typically) follow a Clinical Research Intervention Study Design, supported by Clinical Research Intervention Study Design Systems.
  • which typically contains a Clinical Trial Schedule of Actitivies (specified in a protocol SoA section).
  • It can (typically) be managed by a Clinical Intervention Study Operation, which can involve Clinical Intervention Study Recruitment, ...
  • It can (typically) involve Clinical Interventional Study Stages.
  • It can (often) abide by a Medical Association Rules (medical association).
  • It can (often) be monitored by Clinical Intervention Study Monitoring Task, supported by Clinical Intervention Study Monitoring Systems.
  • It can (often) be managed using a Clinical Research Intervention Study Management System.
  • It can range from being a Medical Treatment Clinical Trial, to being a Medical Product Clinical Trial, to being a Behavioral Intervention Clinical Trial.
  • It can range from being a Controlled Clinical Intervention Study (such as an RCT) to being a Uncontrolled Clinical Intervention Study.
  • It can range from being a Single-Arm Interventional Clinical Study to being a Multi-Arm Interventional Clinical Study.
  • It can range from being a Small-Scale Clinical Research Intervention Study to being a Large-Scale Clinical Research Intervention Study.
  • It can range from being a Regional Clinical Intervention Study (such as an India Clinical Trial) to being a Global Clinical Intervention Study.
  • It can range from being a Government-lead Clinical Trial to being an Organizational-led Clinical Trial, such as a Pfizer-led clinical trial.
  • It can range from being a Centralized Clinical Trial (with clinical research intervention site) to being a Decentralized Clinical Trial (with direct to patient assessments).
  • It can range from being a Phase 1 Clinical Study, to being a Phase 2 Clinical Study to being a Phase 3 Clinical Study to being a Phase 4 Clinical Study.
  • It can be associated with Research Intervention Study Sites.
  • …
• Example(s):
  • a Randomized Interventional Clinical Study, such as NCT01720524 trial.
  • a Before-After Clinical Research Study, when subjects are compared to themselves but not randomized.
  • a Nonrandomized Trial with Historical Controls, when intervention subjects are compared with subjects outside of the study.
  • an Interventional Clinical Research Study Without Comparator, when intervention subjects were not compared with other subjects.
  • a Wait-List Control Groups-based Study.
  • a Therapeutic Agent Intervention Study, such as a: cancer drug intervention study.
  • The Women's Health Initiative (WHI) study, which examined the risks and benefits of hormone replacement therapy in postmenopausal women.
  • The Nurse's Health Study (NHS), which has been ongoing since 1976 and has provided important insights into the relationship between lifestyle factors and chronic diseases in women.
  • The Digital Mammographic Imaging Screening Trial (DMIST), which compared the effectiveness of digital mammography to film mammography for breast cancer screening in women.
  • The Prostate Cancer Prevention Trial (PCPT), which evaluated the effectiveness of finasteride in reducing the risk of prostate cancer in men.
  • The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), which compared the effectiveness of different classes of antihypertensive medications in reducing the risk of cardiovascular disease.
  • The Systolic Blood Pressure Intervention Trial (SPRINT), which aimed to determine whether intensive blood pressure control is more effective than standard blood pressure control in reducing the risk of cardiovascular disease and other complications in older adults.
  • …
• Counter-Example(s):
  • an Observational Clinical Study, such as:
    • a Case-Control Clinical Research Study, when subjects followed overtime? Yes No ??
    • a Cross-Sectional Clinical Research Study, when the interventions assigned randomly? No Yes ??
    • a Cohort Study Clinical Research Study, when the investigator make interventions. ??
  • a Descriptive Clinical Trial,
  • a Diagnostic Clinical Trial,
  • an Clinical Observational Study,
  • a Website Interventional Study.
• See: Research Study, Evidence-based Medicine, Randomized Controlled Experiment, Group-Controlled Experiment, Clinical Trial Monitoring.

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References

2022

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-3-20.
  • Investigational
    • In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental. (NCI)

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/clinical_trial Retrieved:2021-4-4.
  • Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are 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 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. 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.

2020

• (Gene Vision, 2020) ⇒ https://gene.vision/knowledge-base/clinical-trials/
  • QUOTE: ... A clinical trial is a research study conducted in human volunteers to assess whether a new intervention is safe and effective for a specific condition. The intervention tested can either be a new drug, a device, a procedure or even changes to a participants’ behaviour (such as dieting). It is normally tested against a current standard treatment, a placebo or no intervention.

    Trials are conducted by research teams led by a principal investigator, who is usually an expert in the condition and the intervention being studied. The trials may be conducted in only one centre (single-centre trial) or in multiple centres (multicentre trials). Credible trials are strictly regulated and have obtained ethical approval. Funding of clinical trials can come from a variety of sources. These include pharmaceutical companies, medical research councils, universities, charities or a combination of these sources. ...

    

2020

• (ClinicalTrial.gov, 2020) ⇒ https://clinicaltrials.gov/ct2/about-studies/learn#ClinicalTrials
  • QUOTE: ... In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. ...

2018

• (Fogel, 2018) ⇒ David B. Fogel. (2018). “Factors Associated with Clinical Trials That Fail and Opportunities for Improving the Likelihood of Success: A Review.” In: Contemporary Clinical Trials Communications, 11.
  • QUOTE: ... Clinical trials are time consuming, expensive, and often burdensome on patients. Clinical trials can fail for many reasons. This survey reviews many of these reasons and offers insights on opportunities for improving the likelihood of creating and executing successful clinical trials. ...

2014

• (Thiese, 2014) ⇒ Matthew S. Thiese. (2014). “Observational and Interventional Study Design Types; An Overview.” In: Biochemia Medica (Zagreb). Journal, 24(2).
  • QUOTE: Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods(...)

     Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on (...)

    Epidemiological and interventional research studies include three elements; 1) definition and measure of exposure in two or more groups, 2) measure of health outcome(s) in these same groups, and 3) statistical comparison made between groups to assess potential relationships between the exposure and outcome, all of which are defined by the researcher (...). The measure of exposure in epidemiologic studies may be tobacco use (“Yes” vs. “No”) to define the two groups and may be the treatment (Active drug vs. placebo) in interventional studies. Health outcome(s) can be the development of a disease or symptom (e.g. lung cancer) or curing a disease or symptom (e.g. reduction of pain)(...)

     Observational study designs, also called epidemiologic study designs, are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

    Interventional study designs, also called experimental study designs, are those where the researcher intervenes at some point throughout the study. The most common and strongest interventional study design is a randomized controlled trial, however, there are other interventional study designs, including pre-post study design, non-randomized controlled trials, and quasi-experiments.

2012

• (Allison, 2012) ⇒ Malorye Allison. (2012). “Reinventing Clinical Trials.” Nature biotechnology 30, no. 1
  • QUOTE: As R&D costs spiral for drug developers, disruptive approaches to clinical trial design and management are gaining traction. Get ready for electronic data capture, precompetitive data sharing, virtual trials and a variety of bold new paradigms.

2010

• (ClinicaTrials.gov, 2010) ⇒ ClinicalTrials.gov. (2009). “Glossary of Clinical Trials Terms." (2010-09-21)
  • QUOTE: CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (See Phase I, II, III, and IV Trials).

2008

• (Brown, Wang, et al., 2008) ⇒ C. Hendricks Brown, Wei Wang, Sheppard G Kellam, Bengt O. Muthén, Hanno Petras, Peter Toyinbo, Jeanne Poduska, Nicholas Ialongo, Peter A Wyman, Patricia Chamberlain, and The Prevention Science and Methodology Group. (2008). “Methods for Testing Theory and Evaluating Impact in Randomized Field Trials: Intent-to-treat Analyses for Integrating the Perspectives of Person, Place, and Time.” In: Drug and Alcohol Dependence Journal, 95. doi:10.1016/j.drugalcdep.2007.11.013
  • QUOTE: ... This question is centrally concerned with assessing intervention impact across a range of individual, group, and context level characteristics. We note first that population-based randomized preventive field trials have the flexibility of addressing this question much more broadly than do traditional clinicbased randomized trials where selection into the clinic makes it hard to study variation in impact. With classic pharmaceutical randomized clinical trials (P-RCT’s), the most common type of controlled experiment in humans, there is a well accepted methodology for evaluating impact that began with the early pharmacotherapy trials conducted by A. B. Hill starting in the 1940s (Hill, 1962) and is now routinely used by pharmaceutical licensing agencies such as the U.S. Food and Drug Administration and similar agencies in Europe and elsewhere. The most important impact analysis for P-RCTs has been the so-called “intent-to-treat” (ITT) analysis, a set of rigid rules that determine (1) who is included in the analyses — the denominator — (2) how to classify subjects into intervention conditions, and (3) how to handle attrition. …

2004

• (Murray et al., 2004) ⇒ David M Murray, Sherri P Varnell, and Jonathan L Blitstein. (2004). “Design and Analysis of Group-randomized Trials: A Review of Recent Methodological Developments."
  • QUOTE: ... Group-randomized trials (GRTs) are comparative studies designed to evaluate interventions that operate at a group level, manipulate the physical or social environment, or cannot be delivered to individuals.1 Examples include school-, worksite-, and community-based studies designed to improve the health of students, employees, and residents, respectively. Just as the randomized clinical trial (RCT) is the gold standard in public health and medicine when allocation of individual participants is possible, the GRT is the gold standard when allocation of identifiable groups is necessary. ...

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