Ad Hoc Data Sources

Shreya P Gudur
 The term ad hoc refers to the billion of bytes of non-standard and continuously revolving data
spread across all computer systems.
 Such data includes server logs, distributed system performance, telephone records, financial
data.
 An ad hoc data source is any semi-structured data source for which useful data analysis and
transformation tools are not readily available
 The data sources available for Pharmacoepidemiological studies as Ad hoc sources are those
that are collected during post marketing surveillance studies.
 Ad hoc is something which is for or concerned with one specific purpose i.e. providing data
regarding drug safety in long term use or which concerns about the drug aspects in a large
population which is seen in post marketing studies compared to pre marketing studies.
 Limitations of Premarketing Clinical Trials
 Size of the Patient Population Studied
 Narrow Population - often not providing for special groups:
 Elderly, children, women, ethnicity, use in pregnancy, co-morbidities
 Narrow Indications Studied
 Short Duration
 Not reflective of chronic use

 Objectives of post marketing surveillance studies:

---Rare adverse effect
--- AEs in patients different from the study subjects
--- Long-term effects
--- Effectiveness of the drug for the original indications
--- Other beneficial effects of the drugs
 DIFFERENT Ad hoc DATA SOURCES:
 Spontaneous reporting

 Global drug Surveillance : The WHO programme for International Drug Monitoring

 Case-Control Surveillance

 Prescription-Event Monitoring
 Global drug Surveillance - the WHO programme for
International Drug Monitoring

 WHO headquarters in Geneva is responsible for the WHO drug monitoring programme.
Operational aspects are managed by a Swedish foundation named the WHO Collaborating
Centre for International Drug Monitoring in Uppsala (now known as the Uppsala Monitoring
Centre, UMC) according to an agreement signed between WHO and Sweden in 1978. The only
regular budget contribution to the Centre is provided by the Swedish government.
 In each country participating in the WHO programme there is a national centre, appointed by
the government, responsible for collecting spontaneously reported suspicions of ADRs,
originating from health professionals. National centres transform their case reports into a
specific WHO format and submit them to the UMC on a regular basis.
 Functions
 Identification and analysis of new adverse reaction signals from the case report information
submitted to the National Centres, and sent from them to the WHO ICSR database. A data-mining
approach (BCPNN) is used at the UMC to support the clinical analysis made by a panel of signal
reviewers
 Provision of the WHO database as a reference source for signal strengthening and ad hoc
investigations.
 Information exchange between WHO and National Centres, mainly through 'Vigimed', an e-mail
information exchange system
 Publication of periodical newsletters, (WHO Pharmaceuticals Newsletter and Uppsala Reports),
guidelines and books in the Pharmacovigilance and risk management area
 Supply of tools for management of clinical information including adverse drug reaction case
reports. The main products are the WHO Drug Dictionary and the WHO Adverse Reaction
Terminology
 Functions Cont..
 Provision of training and consultancy support to National Centres and countries establishing
Pharmacovigilance systems
 Computer software for case report management designed to suit the needs of National Centres
(VigiFlow)
 Annual meetings for representatives of National Centres at which scientific and organizational
matters are discussed
 Methodological research for the development of Pharmacovigilance as a science.
 The dissemination of information about the ADE’s to the health professionals is done by
Uppsala Reports
The UMC Internet home page. This can be found at http://www.who.pharmasoft.se
An e-mail discussion group called ‘vigimed’.
 Ad Hoc Case-Control Studies
 Case-control studies can be performed as ad hoc studies. Cases can be recruited from whatever
source is appropriate for that disease, whether hospitals, outpatient practices, or some other
source.
 Investigators in some geographic areas maintain ongoing relationships with a number of
hospitals, to permit case finding for case-control studies.
 Case definitions must be clear. Cases should be “incident cases,” that is, individuals who have
recently developed the disease, so one can inquire about exposures that precede the onset of the
disease.
 All individuals who meet the case definition should be enrolled, if possible, to decrease the risk
of a selection bias. Finally, if all cases can be identified in a defined population, then the
incidence of the disease in the population can be determined.
 Controls can then be recruited from either the site of medical care for the cases or from the
community where the cases come from.
 Community controls can be recruited from friends of the cases, from neighbours of the cases,
from a reverse telephone directory, by using random digit dialling, or from some comprehensive
listing of the target population.
 Ad Hoc studies can be whatever size the researcher desires for the study at hand.