Phase IV study and Post marketing Study
CRA
is there any difference in Post Marketing Study and Post marketing
Survillence? Does US FDA/E6 says something on this ?
Looking for your feedback.................
Syed Ehtisham Husain
Hi,
As such, there is no difference between the Phase IV trials and PMS. The fact can be derived while going through the links and write-ups given below carefully. All the write ups are available on the internet, you all can easily access to the sources through the links. Till now, I am not aware that whether PM Study or Surveillance are same or different, as the term Surveillance means strict observation and that is the major purpose of a Phase IV trial. (Kindly send in your comments if this is other way round?).
FDA had, at various incidences given their consideration that they consider Phase IV and PM Studies to be similar. However, I am not sure about anything written about this in E6 guidelines. Kindly share your knowledge on this pertaining to E 6 guidelines.
Phase IIIb/IV Studies. Phase IIIb trials, which often begin before approval, may supplement or complete earlier trials by providing additional safety data or they may test the approved drug for additional conditions for which it may prove useful. Phase IV studies expand testing of a proven drug to broader patient populations and compare the long-term effectiveness and/or cost of the drug to other marketed drugs available to treat the same condition
.
Post-Market Studies. Post-market
studies test a marketed drug in new age groups or patient types. Some studies
focus on previously unknown side effects or related risk factors. As with all
stages of drug development testing, the purpose is to ensure the safety and
effectiveness of marketed drugs.
link--
http://www.ppdi.com/corporate/faq/about_drug_development/home.htm
The term Post marketing Surveillance (PMS) Study implies a scientifically rigorous study of a product that is approved for registration and designed to produce reliable information about drug safety .It is not appropriate to apply the term to clinical trials of registered products or to studies designed primarily for marketing purposes regardless of Scientific validity of study design.
Link—
http://www.ottosen.com/htdocs/uploads//postmarketing_surveillance_studies_guideline.pdf
PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.
http://www.clinicaltrials.gov/ct/info/glossary#double ]
Education and debate
An Ethical Debate: Financial ties as part of informed consent to postmarketing research Attitudes of American doctors and patient
http://bmj.bmjjournals.com/cgi/content/full/310/6995/1660
Phase IV
Studies performed after marketing of the pharmaceutical product. Trials in phase IV are carried out on the basis of the product characteristics on which the marketing authorization was granted and are normally in the form of post-marketing surveillance, assessment of therapeutic value, treatment strategies used and safety profile. Phase IV studies should use the same scientific and ethical standards as applied in pre-marketing studies.
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.
http://www.cdsco.nic.in/html/GCP1.html
Phase IV Study
After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
http://www.centerwatch.com/patient/glossary.html#M
http://www.fda.gov/cber/sba/cfixgen021197-sba.pdf
http://www.fda.gov/cdrh/ode/245.pdf
Hope, this will give some idea about the clarification. Thanks.
Best Regards-
Syed Ehtisham Husain
Clinical Research Associate
Medical Affairs and Clinical Research
Ranbaxy Research Laboratories Ltd.
R&D - IV, 77-B, Sector-18
Gurgaon-122015 (Haryana), INDIA
Phone: 91 124 4012501-10 (Extn:4214)
Fax: 91 124 2342018
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CRA
gathering information from sources about the safety of the product. One
Source could be a Post Marketing Study. Post Marketing Study is a
general term for trials performed after approval, one type is a phase
IV. A phase IV trial can be used for further approvals (eg extended
label, usage) so is sometimes managed like a phase III trial. Other
Post Marketing Studies may be more observational in nature, collect
less data, less SDV performed, less monitoring etc.
In conclusion we can say that Phase IV and PMS are two different things
and PMS comes under Phase IV trial.
Although E6 do not explain anything about the difference but Phase IV
is clearly defined and they are silent on the definition of PMS.
I look forward for the opinion of other members who might not be agree
with.
Thanks