| CTRI Number |
CTRI/2024/03/063441 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Post trial access related in-depth interviews (IDIs) with key informants and focus group discussion (FGDs) with patients |
|
Scientific Title of Study
|
To explore the experience, roles, responsibilities, perceptions, challenges and expectations of stakeholders on Post-Trial Access (PTA) during epidemic/pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya Gogtay |
| Designation |
Professor and Head Department of Clinical Pharmacology |
| Affiliation |
Seth GSMC and KEMH Mumbai |
| Address |
Department of Clinical Pharmacology 1st Floor Multi storeyed Building Seth GSMC and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820495836 |
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Parida |
| Designation |
DM Resident Department of Clinical Pharmacology |
| Affiliation |
Seth GSMC and KEMH Mumbai |
| Address |
Department of Clinical Pharmacology 1st Floor Multi storeyed Building Seth GSMC and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8743907794 |
| Fax |
|
| Email |
dr.roopaparida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Parida |
| Designation |
DM Resident Department of Clinical Pharmacology |
| Affiliation |
Seth GSMC and KEMH Mumbai |
| Address |
Department of Clinical Pharmacology 1st Floor Multi storeyed Building Seth GSMC and KEM Hospital Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8743907794 |
| Fax |
|
| Email |
dr.roopaparida@gmail.com |
|
|
Source of Monetary or Material Support
|
| University of Oslo The Research Council of Norway |
|
|
Primary Sponsor
|
| Name |
University of Oslo The Research Council of Norway |
| Address |
University of Oslo PO Box 1130 Blindern 971 035 854, OSLO, Norway |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
Brazil
India
Kenya
Nepal
Norway
Philippines
Tanzania |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nithya Gogtay |
Seth GS Medical College and KEM Hospital Mumbai |
201, Department of Clinical Pharmacology, 1st Floor, New MS building, Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA |
9820495836
njgogtay@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC 3 Seth GS Medical College and KEM Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Willing to give written informed consent or verbal consent in case the interviews are conducted online [for example with sponsors and regulators]
Pharmaceutical Sponsors /CROs, researchers, regulators and ethics committee members who are willing to give consent for the interview and who were involved in any manner with at least one study during the COVID -19 pandemic.
Covid-19 patients/ vaccine/ investigational product recipients.
|
|
| ExclusionCriteria |
| Details |
Stakeholders in Non COVID -19 studies conducted during the pandemic |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Understanding perceptions, challenges, benefits of PTA amongst the various stakeholders |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding experiences of PTA beneficiaries in terms of benefits, challenges and expectations |
1 year |
|
|
Target Sample Size
|
Total Sample Size="840"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-trial arrangement [PTA] or post-trial access [PTA] refers to making the intervention that has been
studied in the clinical trial/s especially by the pharmaceutical industry available to those who took part
in the study or a wider population from which the study participants were drawn. PTA includes many stakeholders and they are - Pharmaceutical Sponsors, investigators and
researchers, policy makers, governments, and even trade associations. to include communities, policy
makers, governments, and trade associations. Guidelines on PTA are limited especially in LMICs and
this study hopes to address this gap. It has been envisaged with the broad aim of understanding how
PTA works [or otherwise] in LMICs through qualitative research.
The study essentially will use questionnaires to interview the multiple stakeholders listed now either
as one on one discussions or focused group discussions. Whatever comes out from these interviews
will be “coded†to find “themes†meaning what really do all these stakeholders feel about PTA. |