Investigational Clinical Product
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An Investigational Clinical Product is a clinical product that can be analyzed in a clinical study.
- Example(s):
- Counter-Example(s):
- See: Clinical Intervention, Therapeutic.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Good_clinical_practice Retrieved:2021-11-19.
- QUOTE: ... Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. ...
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_study_design Retrieved:2021-11-21.
- Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. [1] The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. ...
- ↑ Miquel Porta (2014) "A dictionary of epidemiology", 6th edn, New York: Oxford University Press. .
2020
- https://www.niaid.nih.gov/research/dmid-investigational-product
- QUOTE: An investigational product refers to a preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial. An investigational product may be an unlicensed product or a licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
The following links provide Division of Microbiology and Infectious Diseases (DMID) staff and DMID clinical investigators with information on DMID procedures for handling and administering investigational products in DMID-funded clinical trials. The DMID Office for Regulatory Affairs (ORA) should be contacted for specific questions.
- QUOTE: An investigational product refers to a preventative (vaccine), a therapeutic (drug or biologic), device, diagnostic, or palliative used in a clinical trial. An investigational product may be an unlicensed product or a licensed product when used or assembled (formulated or packaged) differently from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.
2019
- https://michr.umich.edu/resources/2019/2/20/investigational-product-ip-standard-practice-guidelines
- QUOTE: ... The management of an Investigational Product (IP) is a complex and highly regulated activity. The IP may be a drug, biologic, medical device, or combination product; each of which may have unique regulatory and accountability requirements. ...
2009
- (Gracia et al., 2009) ⇒ Jose L. Perez-Gracia, Pedro Berraondo, Ivan Martinez-Forero, Carlos Alfaro, Natalia Suarez, Alfonso Gurpide, Bruno Sangro et al. (2009). “Clinical Development of Combination Strategies in Immunotherapy: Are We Ready for More Than One Investigational Product in An Early Clinical Trial?. ” Immunotherapy 1, no. 5
- ABSTRACT: ... In cancer immunotherapy, two agents that have minor or no therapeutic effects as single agents can be powerful when combined. Mouse experimentation provides multiple examples of synergistic combinations. Elements to be combined include chiefly: tumor vaccines, adoptive T-cell therapies, cytokines, costimulatory molecules, molecular deactivation of immunosuppressive or tolerogenic pathways and immunostimulatory monoclonal antibodies. These novel therapies, even as single agents, are extremely complex products to be developed owing to the associated biomolecules, cell therapies or gene therapies. At present, drug-development programs are run individually for each immunotherapeutic agent and combinations are considered only at a later stage in clinical development, even in the absence of formal compulsory regulations to prevent clinical trials with combinations. As a result, instead of the search for maximal efficacy, ease of combination with standard treatments, intellectual property management, regulations and business-based decisions often guide the way. Even though the maximal effort must be made in order to prevent adverse effects in patients, it seems reasonable that combination pilot trials should be performed at an early stage, following safe completion of Phase I trials. These trials should be performed based on evidence for synergy in animal models and be simplified in terms of regulatory requirements. Such ‘short-cut’ combination immunotherapy trials can bring much needed efficacy earlier to the bedside.