COPHARIX

Observational and Epidemiologic Studies

 

Copharix Phase IV Post-Marketing Observational and Epidemiologic Studies will be provided in response to the growing demand for these resources.  This demand is generated in part by requirements of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)) and by reference Section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).   Global pressures for cost control have insurers demanding real-world evidence about pharmaceutical product quality and effectiveness.  Gradually replacing or reducing dependence on Phase 3 trials with smaller, faster adaptive trials combined with post-market surveillance will have a positive impact on accelerating medical innovations.  Search for new indications and uses of approved pharmaceuticals depends on the real world effectiveness of a drug as evaluated in observational, non-interventional trials in a naturalistic setting which complements the efficacy data that emanates from a pre-marketing randomized controlled trials. Surveillance of spontaneously reported adverse events continues as long as a product is marketed, as a result Phase IV studies are required over the long term.

 

Copharix Phase IV Observational and Epidemiologic Services will address these market opportunities by providing resources under provisions of the “Guidance for Industry – Postmarketing Studies and Clinical Trials – Implementation of Section 505(o)(3) of the Federal Food, Drugs and Cosmetics Act, U. S. Department of Health and Human Services – Food and Drug Administration – Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), April 2011”.  Section 505(o)(3) sets forth requirements for postmarketing studies for prescription drugs approved under section 505(b) of the FDAAA.  In the past, FDA has used the term Post Marketing Commitment (PMC) to refer to certain studies (including clinical trials), conducted by an applicant after FDA has approved a drug for marketing or licensing, that were intended to further refine the safety, efficacy, or optimal use of a product or to ensure consistency and reliability of product quality.  For the purposes of implementing section 901 of FDAAA, Observational and Epidemiologic Studies are investigations, such as investigations with humans that are not clinical trials (e.g., observational epidemiologic studies), animal studies, and laboratory experiments.  Examples of observational studies include pharmacoepidemiologic studies designed to:  Estimate the risk of a serious adverse event or toxicity associated with use of a drug; Provide estimates of absolute risk (e.g., incidence rates) for a serious adverse event or toxicity; Obtain long-term clinical outcome data, including information about potentially rare serious adverse events, in patients taking the drug compared to patients not exposed to the drug; Identify risk factors (e.g., patient characteristics, duration of drug use) associated with the occurrence of adverse events among patients exposed to specified drugs; Compare pregnancy incidence, pregnancy outcomes, and/or child outcomes after patient drug exposure compared to patients who did not receive the drug.  Data sources for observational studies include administrative health care claims data, electronic medical records, prescription records, registries, collected observational data, or other sources of observational information.