Clinical Research Performance Data Summary 2006–2008
|
2008 |
2007 |
2006 |
| Phase II–V clinical trials initiated in number of countries*†‡ |
36 studies conducted in 62 countries
|
45 studies conducted in 54 countries
|
43 studies conducted in 49 countries
|
|
Number of GCP/PV audits by Regulatory Agencies of Merck or clinical trial investigators
|
42
|
35
|
36
|
* Prior year data have been adjusted due to a change in methodology.
† Phase V trials are conducted to etermine new uses for existing products and / or broader health and economic outcomes.
‡ We have modified this KPI from las year to report clinical trials initiated vs. clinical trials conducted.
- Merck developed a procedure for compassionate use programs. Programs may be conducted under the following circumstances: the disease is life-threatening or severely debilitating: not alternative treatments are available for patients: a patient is not eligible for a clinical trial; and a marketing authorization is planned in the future.
- Merck has finalized a set of Guiding Principles for Business Practices Involving the Medical and Scientific Community.
- MRL implemented a procedure in November 2008 that describes the types of engagement opportunities during which MRL staff may seek input from external scientists to inform the development of MRL scientific strategy or operations from discovery through late stage development. This procedure provides a consistent approach that ensures compliance with applicable laws, regulatory requirements and Merck policies.
Of 42 inspections conducted by regulatory agencies worldwide in 2008, none resulted in critical observations and none resulted in the rejection of any clinical study or regulatory filing.
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