Investigators financial disclosure

A Form 1572 is used for investigators to summarise their educational qualifications and experience, and to make a required formal declaration as to their commitment to conduct the study according to the protocol, GCP and the regulations. The sponsor should also collect financial disclosure information from the investigators at this stage, although formal declarations on Form 3455 are not required until the submission of a marketing authorisation application. 

Sec. 312.50 General responsibibties of sponsors Protection of Human Subjects Financial Disclosure by Clinical Investigators Institutional Review Boards (IRBs)... 

Before commencing a study, the investigator should make a financial disclosure. Most future products will need to benefit from the potential sales of the US market. Even when there is a considerable financial interest in the success of the product, the financial disclosure will not necessarily rule out the investigator s role in the study totally. Most inspectorates are more interested in what is not declared than what is. 

Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER). Guidance for Industry, Center for Devices and Radiological Health (CDRH). Draft Guidance for Industry Financial Disclosure by Clinical Investigators, Oct. 26, 1999. 

GCP protocols and amendments Clinical investigation and changes Financial disclosure forms and reports Investigator statement... 

Part 54 — Financial Disclosure by Clinical Investigators, http //www.access.gpo.gov/nara/ cfr/waisidx 01/21 cfr54 01. html. 

Food and Drug Administration (FDA). Financial disclosure by clinical investigators. Title 21 Code of Federal Regulations Parts 54, 312, 314, 320, 330, 601, 807. Federal Register 1998 63(21) 5233-54. 

Includes general enforcement regulations, product jurisdiction, enforcement policy, hearings, protection of human subjects, financial disclosure by clinical investigators, institutional review boards, and good laboratory practice for nonclinical laboratory studies. 

The PMA is not accompanied by a statement of either certification or disclosure as required by 21 CFR Part 54 Financial Disclosure by Clinical Investigators. 

In addition, the investigator must complete Financial Disclosure Forms, i.e., FDA Form 3454 (no financial interest) or FDA Form 3455 (financial interest). These forms will confirm any or no financial involvement of the investigator with the company or product they are investigating. 

One of the newest components of a clinical trial is financial disclosure. This regulation initiated in the United States on February 2, 1999, is required on all current or ongoing clinical trials filed in an IND. It is not retroactive to studies completed prior to this date. Financial disclosure is defined by the FDA as compensation related to the outcome of the study, proprietary interest in the product (e.g., patent), significant equity interest in the sponsor of the study, significant payments of other sorts to the investigator or institution... 

F inancial disclosure section under 21 CFR 54. This covers financial disclosure for clinical investigators to ensure that financial interests and arrangements of clinical investigators that could affect reliability of data submitted to the FDA in support of product marketing are identified and disclosed by the sponsor (http //www.fda.govl cder/about/smallbiz/financial disclosure. htm). 

Globally, there is concern that biased results could be produced from studies conducted by investigators who own shares or other financial benefits in the pharmaceutical company sponsoring their trials. The Declaration of Helsinki (2000) requires that sources of fimding, institutional affiliations and possible conflicts of interest should be declared in any publication. All studies conducted on products that are likely to be part of a submission to the US FDA require the sponsor to make a disclosure of financial holdings of the investigators that participate in all studies. Any significant pa)unents (US 25000)... 

Full disclosure of financial liaisons and relationships of investigators. An important aspect is to exclude any conflict of interest between the study participants and the investigator s self-interest (financial, scientific, carrier, etc.)- Only voluntary participation in a study is acceptable, and patients (participants) must have the right to withdraw from a study at any time. 

For each clinical investigator, the NDA should include either a certification that the investigator did not have any financial interests that could be considered to be a conflict of interest, or a disclosure of the financial interests. 

Form FDA 3455 - Disclosure Financial Interests and Arrangements of Clinical Investigators. http //forms.psc.gov/forms/FDA/FDA-3455.pdf. 

---