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Assortment of Pills

ClinicalTrials.gov Registration Data Element(s)

World Health Organization (WHO)/International Committee of Medical Journal Editors (ICMJE) –
ClinicalTrials.gov Cross Reference

 

1 WHO Trial Registration Data Set: http://www.who.int/ictrp/network/trds/en/index.html 
2 ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies:
http://prsinfo.clinicaltrials.gov/definitions.html
 

Clinical study protocols

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines for the development of clinical study protocols. The ICH website provides access to all ICH guidelines, including those related to clinical study protocols.

The specific guideline related to clinical study protocols is ICH E6(R2) Good Clinical Practice (GCP), which outlines the ethical and scientific standards for designing, conducting, recording, and reporting clinical studies involving human subjects.

You can access this guideline on the ICH website through the following link:

Investigator's Brochure (IB)

An Investigator's Brochure (IB) is a document that provides essential information about an investigational drug or medical device to clinical trial investigators and other medical professionals involved in the study. It serves as a comprehensive reference guide for the investigators, enabling them to understand the characteristics, properties, and potential risks associated with the investigational product.

The purpose of the Investigator's Brochure is to provide a detailed overview of the product under investigation and its development history. It typically includes the following information:

  1. Introduction: Provides background information about the investigational product, including its generic name, chemical structure, and pharmacological class.

  2. Investigational Product Description: Describes the composition, formulation, and dosage forms of the product, as well as any available information on its stability, manufacturing, and quality control procedures.

  3. Pharmacology and Mechanism of Action: Explains how the investigational product works in the body, including its mode of action, pharmacokinetics (absorption, distribution, metabolism, and excretion), and pharmacodynamics (effects on the body).

  4. Preclinical Data: Summarizes the results of non-clinical studies conducted in animals or in vitro, including information on pharmacology, toxicology, and any relevant safety findings.

  5. Clinical Data: Provides an overview of previous clinical trials conducted with the investigational product, including data on safety, efficacy, and dosing regimens. It may also include information on any adverse events, drug interactions, or special precautions identified during previous studies.

  6. Safety Profile: Presents a comprehensive assessment of the safety profile of the investigational product, including known and potential risks, side effects, and adverse reactions. This section may also include information on contraindications, warnings, and precautions.

  7. Regulatory Information: Provides details on the regulatory status of the product, including any approvals or authorizations obtained from regulatory agencies and any ongoing regulatory commitments.

  8. References: Lists the scientific literature, published studies, or other relevant sources of information used to compile the Investigator's Brochure.

The Investigator's Brochure serves as a valuable resource for investigators to ensure they have a thorough understanding of the investigational product before conducting clinical trials. It helps them make informed decisions and ensures the safety and well-being of study participants.

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Clinical study reports

The clinical study report (CSR) is a comprehensive document that summarizes the results and findings of a clinical study. The following are the steps involved in the preparation of a CSR:

  1. Introduction: This section provides a brief background of the study and its objectives.

  2. Study design and methods: This section describes the study design, methodology, and procedures that were followed during the study, including the inclusion and exclusion criteria, study population, interventions, and endpoints.

  3. Results: This section presents the results of the study, including the primary and secondary endpoints, efficacy and safety data, and any relevant statistical analyses.

  4. Discussion: This section provides an interpretation of the study results, including any limitations or weaknesses of the study and implications for future research.

  5. Conclusions: This section summarizes the main findings of the study and draws conclusions regarding the safety and efficacy of the study intervention.

  6. Appendices: This section includes any additional information that may be relevant to the study, such as study protocols, data collection forms, and statistical analyses.

ICH E3 guideline provides guidance on the content and format of clinical study reports. This guideline outlines the general structure and content of the CSR, as well as specific requirements for different types of clinical studies, such as pharmacokinetic and pharmacodynamic studies.

You can access the ICH E3 guideline on the ICH website through the following link:

02

Clinical development plans

Clinical development plans (CDPs) are comprehensive documents that outline the strategic approach to the development of a new drug or medical product. The following are the steps involved in the preparation of a CDP:

  1. Pre-clinical research: This stage involves laboratory and animal studies to evaluate the safety and efficacy of the drug and to identify potential risks or adverse effects.

  2. Phase 1 clinical trials: This stage involves small-scale clinical trials to evaluate the safety and tolerability of the drug in healthy volunteers.

  3. Phase 2 clinical trials: This stage involves larger-scale clinical trials to evaluate the safety and efficacy of the drug in a patient population.

  4. Phase 3 clinical trials: This stage involves large-scale clinical trials to confirm the safety and efficacy of the drug and to evaluate its effectiveness in comparison to existing treatments.

  5. Regulatory approval: This stage involves submitting the results of the clinical trials to regulatory agencies for approval of the drug for marketing and distribution.

  6. Post-marketing surveillance: This stage involves ongoing monitoring of the safety and effectiveness of the drug after it has been approved for use.

ICH E6(R2) Good Clinical Practice (GCP) provides guidance on the design, conduct, and reporting of clinical trials, including the development of clinical development plans. The guideline emphasizes the importance of a systematic and well-planned approach to the development of new drugs and medical products, and provides recommendations for the different stages of clinical development.

You can access the ICH E6(R2) guideline on the ICH website through the following link:

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IND submissions and annual reports

Preparing an investigational new drug (IND) submission and annual report involves a comprehensive process that requires adherence to various regulatory guidelines and requirements. The following are the general steps involved in the preparation of IND submissions and annual reports:

  1. Pre-IND meeting: This step involves meeting with regulatory authorities to discuss the proposed clinical trial and to obtain guidance on the content and format of the IND submission.

  2. Investigational new drug application (IND): This step involves the preparation and submission of an IND to regulatory authorities, which includes information on the drug substance, manufacturing processes, preclinical studies, and clinical trial protocols.

  3. Clinical trials: This step involves conducting the clinical trials according to the protocols and guidelines outlined in the IND submission.

  4. Annual reports: This step involves the preparation and submission of annual reports to regulatory authorities, which includes updated information on the drug substance, clinical trial results, adverse events, and any changes to the manufacturing or clinical trial protocols.

ICH M4 guidance provides recommendations for the preparation of IND submissions, including the content and format of the submission. ICH E2F guidance provides recommendations for the preparation of annual reports, including the content and format of the report.

You can access the ICH M4 guidance on the ICH website through the following link: 

 

 

 

 

You can access the ICH E2F guidance on the ICH website through the following link:​

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Investigator brochures

An investigator brochure (IB) is a comprehensive document that provides information on an investigational drug or medical product to investigators participating in clinical trials. The following are the steps involved in the preparation of an IB according to ICH guidelines:

  1. Introduction: This section provides an overview of the drug or medical product, including its composition, mechanism of action, and intended use.

  2. Non-clinical data: This section describes the results of non-clinical studies, including pharmacology, toxicology, and safety data.

  3. Clinical data: This section describes the results of previous clinical trials, including pharmacokinetics, pharmacodynamics, and safety data.

  4. Investigational plan: This section describes the objectives, design, and methodology of the proposed clinical trial, including inclusion and exclusion criteria, dosing, and endpoints.

  5. Safety information: This section provides information on the safety of the investigational drug or medical product, including potential risks and adverse events, and instructions for reporting adverse events.

  6. Manufacturing information: This section provides information on the manufacturing process, quality control, and stability of the investigational drug or medical product.

ICH E6(R2) Good Clinical Practice (GCP) provides guidance on the preparation of IBs for clinical trials. The guideline emphasizes the importance of providing clear and accurate information on the investigational drug or medical product, as well as potential risks and safety concerns.

You can access the ICH E6(R2) guideline on the ICH website through the following link:

 

 

 

 

What is the interventional and non-interventional clinical study? 

Interventional clinical studies are research studies that involve actively intervening in the participants' health status by administering a specific treatment or intervention, such as a drug, therapy, or procedure. These studies are also called interventional trials or clinical trials and aim to evaluate the safety and effectiveness of the intervention being tested.

Non-interventional clinical studies, also known as observational studies, do not involve administering any specific treatment or intervention to the participants. Instead, researchers observe and collect data on the participant's health status, behaviors, or outcomes over a certain period. These studies aim to explore associations or relationships between variables, such as risk factors and disease outcomes, without intervening in the participants' health.

Some common types of interventional clinical studies include:

  1. Randomized controlled trials (RCTs): These studies randomly assign participants to receive either the experimental intervention or a control intervention, such as a placebo and then compare the outcomes between the two groups.

  2. Phase I-IV trials: These trials test the safety, dosage, and effectiveness of new drugs or interventions in different stages of development.

  3. Non-randomized trials: These studies do not use randomization but instead assign participants to groups based on certain criteria, such as age, gender, or health status.

Some common types of non-interventional clinical studies include:

  1. Cohort studies: These studies follow a group of individuals over a certain period to observe and record specific outcomes.

  2. Case-control studies: These studies compare individuals with a particular health outcome (cases) to those without (controls) to identify potential risk factors or causes.

  3. Cross-sectional studies: These studies measure variables of interest at a single point in time to identify associations or relationships.

  4. Ecological studies: These studies examine associations between health outcomes and environmental or social factors at the population level.

  5. Case series and case reports: These studies describe the medical history, symptoms, and outcomes of individual patients or a small group of patients with a particular condition.

  6. Meta-analyses and systematic reviews: These studies analyze and summarize the findings from multiple studies on a particular topic to provide an overall assessment of the evidence.

Both interventional and non-interventional clinical studies play important roles in advancing medical knowledge and improving patient care. Interventional studies are particularly valuable in evaluating the safety and efficacy of new treatments, while non-interventional studies can provide valuable insights into disease patterns, risk factors, and patient outcomes. Ultimately, the choice between interventional and non-interventional studies depends on the research question being asked and the type of evidence needed to answer it.

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