July 21, 2022
TABLE OF CONTENTS
Ethical collaboration between practitioners and industry is essential to advances in medicine. However, laws and institutional policies sharply circumscribe the ways in which these two groups can interact.
Real-world studies represent an important medium through which such interaction can properly and effectively occur. As is the case with traditional RCT’s, industry can support investigators who are conducting independent and properly designed studies through study fees, honoraria and product discounts.
RegenMed provides the clinical grade yet cost-effective tools and processes intermediating the funding and execution of real-world studies.
An Investigator Initiated Trial (“IIT”) is a common example of real-world study ethically accommodating the objectives of the independent provider, as well as a third party with related objectives which can provide financial support.
An IIT is a study where the study investigator is also the study sponsor. In other words, the Investigator is not only responsible for execution of the study, but also for its design and oversight. In an IIT, the investigator is therefore called the Sponsor-Investigator.
Many medical product manufacturers, foundations, governmental and non-governmental organizations have programs to help fund IIT’s.
The Sponsor-Investigator may be an individual clinician, small clinic, medical society, or a hospital department.
Although each category differs markedly in its capacity to design and manage an ITT, it is unlikely any will be able properly to do so without third-party support. (The only exception is a large academic/medical center, which has in place a Clinical Trial Unit or similar infrastructure.)
Although real-world studies can be executed efficiently even by individual clinicians, the expectations of IIT funding sources usually demand a more robust study design and management infrastructure. Typical elements are described in the following section.
An IIT usually involves the following important elements:
An IIT Sponsor-Investigator will apply to a suitable funding source. This process typically begins with a “concept note” which, if approved, will be fleshed out into a more thorough study design. Many IIT funding sources articulate their IIT criteria and evaluation processes on their websites. The concept note of course should be drafted in accordance with these guidelines.
It is important to distinguish between two types of “audiences”: clinical/ scientific and business. Usually, both groups will be involved in evaluating an IIT application. Sometimes, however, the evaluation may be made solely by the clinical/scientific group. This factor obviously dictates the emphasis of certain elements of the application.
Important components of an IIT application include:
These are the parameters pursuant to which the study will be carried out. Key components include:
Important items here include:
This element includes medical writing, diagrams and tables, citations, journal selection. Some funding sources may look for publication in peer-reviewed print journals; others may be satisfied with publication through on-line journals or presentations of abstracts at conferences
Important F.D.A. links relating to ITT’s include:
Copyright © 2022 Regenerative Medicine LLC
July 21, 2022
TABLE OF CONTENTS
Ethical collaboration between practitioners and industry is essential to advances in medicine. However, laws and institutional policies sharply circumscribe the ways in which these two groups can interact.
Real-world studies represent an important medium through which such interaction can properly and effectively occur. As is the case with traditional RCT’s, industry can support investigators who are conducting independent and properly designed studies through study fees, honoraria and product discounts.
RegenMed provides the clinical grade yet cost-effective tools and processes intermediating the funding and execution of real-world studies.
An Investigator Initiated Trial (“IIT”) is a common example of real-world study ethically accommodating the objectives of the independent provider, as well as a third party with related objectives which can provide financial support.
An IIT is a study where the study investigator is also the study sponsor. In other words, the Investigator is not only responsible for execution of the study, but also for its design and oversight. In an IIT, the investigator is therefore called the Sponsor-Investigator.
Many medical product manufacturers, foundations, governmental and non-governmental organizations have programs to help fund IIT’s.
The Sponsor-Investigator may be an individual clinician, small clinic, medical society, or a hospital department.
Although each category differs markedly in its capacity to design and manage an ITT, it is unlikely any will be able properly to do so without third-party support. (The only exception is a large academic/medical center, which has in place a Clinical Trial Unit or similar infrastructure.)
Although real-world studies can be executed efficiently even by individual clinicians, the expectations of IIT funding sources usually demand a more robust study design and management infrastructure. Typical elements are described in the following section.
An IIT usually involves the following important elements:
An IIT Sponsor-Investigator will apply to a suitable funding source. This process typically begins with a “concept note” which, if approved, will be fleshed out into a more thorough study design. Many IIT funding sources articulate their IIT criteria and evaluation processes on their websites. The concept note of course should be drafted in accordance with these guidelines.
It is important to distinguish between two types of “audiences”: clinical/ scientific and business. Usually, both groups will be involved in evaluating an IIT application. Sometimes, however, the evaluation may be made solely by the clinical/scientific group. This factor obviously dictates the emphasis of certain elements of the application.
Important components of an IIT application include:
These are the parameters pursuant to which the study will be carried out. Key components include:
Important items here include:
This element includes medical writing, diagrams and tables, citations, journal selection. Some funding sources may look for publication in peer-reviewed print journals; others may be satisfied with publication through on-line journals or presentations of abstracts at conferences
Important F.D.A. links relating to ITT’s include:
Copyright © 2022 Regenerative Medicine LLC