Post Authorization Studies for Clinical Research Purposes - Pepgra
                     Post Authorization Studies for Clinical Research Purposes 
 
 
Dr. Nancy Agnes, Head, 
Technical Operations, Pepgra 
[email protected] 
 
 
 
In-Brief The purpose of the PASS is to evaluate the 
 safety and benefit-risk profile of a medicinal 
Have a look at post-authorization safety product and to support regulatory decision-
studies and important making.The protocols and results of PASS's 
pharmacoepidemiological and access is with the Pharmacovigilance Risk 
pharmacovigilance aspects in clinical Assessment Committee (PRAC) 
research in this Pepgra blog.PASS covers  
different types and limitations of II. AIMS OF PASS 
surveillance programs, such as the use of  
large databases and disparate data sources Identify, characterize, or quantify a safety 
for rapid signal detection, as well as novel hazard; Confirm the safety profile of a 
and advanced design and analysis medicine; or, Measure the effectiveness of 
approach for causal interference from risk-management measures. PASSs can 
observational information. either be clinical trials or non-interventional 
studies. Under the EU legislation, a post-
 
authorization study is classified as a PASS 
Keywords: 
when the main aims for initiating the study 
Clinical research organization, Clinical 
include: Quantification of risks or providing 
trial Monitoring Services, Clinical 
evidence about the absence of risks 
Biostatistics services, pharmaceutical 
Evaluation of risks in populations with 
regulatory consulting services, healthcare 
limited or missing safety data. Assessment 
data analytics services, pharmacovigilance 
of patterns of drug utilization that gives 
literature search services, clinical study 
information on the safety profile. 
design, Biomedical research, clinical study 
Measurement of the effectiveness of a risk 
protocol, clinical trial protocol, 
minimization activity. The British Journal of 
therapeutics clinical research 
Pharmacology analysis showed that 74% of 
 
PASS had a focus on investigating safety 
I. INTRODUCING POST-
concerns, while 34% focused on drug 
AUTHORIZATION SAFETY STUDIES 
utilization, and 25% on the effectiveness of 
(PASS) 
risk minimization. In one-third of the PASS, 
 
more than one of these objectives present in 
A PASS, an authorization of a study carried 
the protocol. Some 35% of the PASS had 
out after a medicinal product, to obtain 
effectiveness endpoints as well as safety 
further information on a medicinal product's 
ones. It may reflect the facts that PASS is 
safety or to measure the effectiveness of 
expensive and long-term commitments for 
risk-management measures 
sponsors, with the result that it is desirable 
to capture routine effectiveness data in the 
Copyright © 2021 pepgra. All rights reserved  1 
 
real world. Concerning the study population, the need for improved study design, based 
12% of the overall PASS is of pregnancy on current guidelines and 
registries, and 18% included pediatric pharmacoepidemiological principles. 
patients only. Also, 22% of PASS targeted Looking ahead, it will be vital to building 
healthcare professionals, with the great cooperation between PASS stakeholders to 
majority of these (94%) aimed at assessing support transparent and methodologically 
the effectiveness of risk minimization efforts sound studies that align with other risk 
and drug utilization.  management approaches. This collaborative 
 generation of knowledge will be integral to 
 strengthening the capacity of the EU to 
deliver better and safer therapies.  
 
IV. CHANGES IN PASS 
 
Transparency:  
The EMA is working on new mechanisms to 
increase data transparency and compliance 
by sponsors with ENCePP standards and 
requirements (code of conduct, checklists, 
EU-PAS registration). Key will be better 
promotion of ENCePP Study Seal, a quality 
mark designed to recognize high standards 
throughout the research process based on the 
principles of robust methodologies, 
 
 transparency and scientific independence. 
  
 Methodology: 
III. ACTIONS TO FOSTER PASS A considerable number of PRAC comments 
COLLABORATION AND BRIDGE related to methodological issues and 
PHARMACOVIGILANCE AND feasibility concerns should raise awareness 
PHARMACOEPIDEMIOLOGY among PASS stakeholders of the need to 
 design more thoughtful studies, according to 
The currently available information on pharmacoepidemiological principles and 
PASS offers critical insights into design and existing guidelines. Currently, most PASS is 
conduct of PASS under the new European detailed studies, involving a simple, long-
pharmacovigilance legislation. The new term, descriptive analysis of patients who 
analysis indicates that there is scope for have taken the drug, with no comparator. 
further improvements in transparency from Hybrid studies involving both primary and 
both regulators and MAH. The EMA could secondary data collection present more 
increase the availability of protocol frequently in future. Today's 
assessments within the EU-PAS, while pharmacoepidemiological toolbox offers 
PASS sponsors could improve access to and many additional options, such as the ability 
documents in the register. The large number to model links between exposure and 
of PRAC comments involving in the outcomes. Such approaches could improve 
methodological issues and feasibility the design of PASS. Also, new guidelines 
concerns should alert PASS stakeholders for for post-authorization efficacy studies 
Copyright © 2021 pepgra. All rights reserved  2 
 
(PAES) 8 have just been released, with a  
final version expected in 2017; this is likely REFERENCES 
to lead to increasing numbers of requests by  
regulatory authorities for PAES in addition 1. Cohet, C., Rosillon, D., Willame, C., Haguinet, F., 
Marenne, M. N., Fontaine, S., ... & Baril, L. (2017). 
to PASS. Clinical trial design options for Challenges in conducting post-authorization safety 
designing of PAES include explanatory and studies (PASS): A vaccine manufacturer's 
pragmatic trials. view. Vaccine, 35(23), 3041-3049. 
2. Huberlant, B., KWADE, Z., & VAN RIEL, A. N. N. I. 
 C. K. (2011). Post authorization safety studies 
Definitions: (PASS); Updated EU regulations. LIFE SCIENCE I 
In the EU Clinical Trial Regulation, the new TECHNICAL BULLETIN. ISSUE N, 42. 
 
description of PASS will rise into effect, 
impacting classification of it. It results in, 
and some studies classification will be 
observational studies, resulting in a different 
review process and pose a challenge for 
study sponsors in the coming year. Also, 
when the new clinical trial regulation comes 
into force, it will become essential to 
scrutinize possible rules in the ethics 
committee decision-making across Europe 
and their impact on the conduct and the 
implementation of PASS. 
 
Governance: 
In future, there will be more joint studies 
involving multiple products, sponsors, 
academics and CROs within a therapeutic 
category. Such tasks will need new 
governance structures. EU initiatives, such 
as the IMI accelerates the development of 
vaccine benefit-risk collaboration in Europe 
(ADVANCE) project. The EMA initiative 
for patient registries represents promising 
opportunities to expand joint efforts using 
new governance models, with the potential 
to deliver robust results with statistical 
significance. 
 
V. CONCLUSION 
 
These are the few important topics that 
every clinical researcher should possess 
knowledge of post-authorization services. 
Pepgra has stated many essential aspects and 
changes in the clinical research field to help 
healthcare data analytics services. 
Copyright © 2021 pepgra. All rights reserved  2