| CTRI Number |
CTRI/2025/10/096700 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
tracking the safety and value of cancer drugs in a specialised hospital |
|
Scientific Title of Study
|
Pharmacovigilance and Pharmacoeconomics of cancer chemotherapy medications in a tertiary care hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohan Motwani |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pharmacology, 2nd floor, JNMC building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8460736039 |
| Fax |
|
| Email |
rohanjmotwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swanad S Pathak |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pharmacology, 2nd floor, JNMC building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9420529850 |
| Fax |
|
| Email |
swanandspathak@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swanad S Pathak |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Pharmacology, 2nd floor, JNMC building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9420529850 |
| Fax |
|
| Email |
swanandspathak@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohan Motwani |
SGM Cancer Hospital |
Dept. of Oncology, 1st Floor, SGM Cancer Hospital building, AVBRH Campus, Sawangi
Wardha
MAHARASHTRA |
8460736039
rohanjmotwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Medical and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Cancer patients on chemotherapy treatment
2. Patients with solid tumors or hematological malignancy |
|
| ExclusionCriteria |
| Details |
1. Patient not consenting for study
2. Patients on Radiation Therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse Drug Reaction, Drug Interaction, cost effectiveness, cost utility and budget impact of chemotherapeutic medication |
Assessment will be done at two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140"
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)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pharmacoeconomics and pharmacovigilance are not separate departments in a tertiary care hospital. Pharmacoeconomic analyses are directly informed by the frequency and severity of adverse drug reactions (ADRs) data collected through pharmacovigilance. A medication that frequently and severely causes side effects, for example, may result in longer hospital stays and the need for additional treatments, raising the overall cost of care.
Tertiary care hospitals can make well-informed decisions about which cancer chemotherapeutic drugs to add to their formularies by combining these two domains, guaranteeing a balance between treatment effectiveness, patient safety, and financial viability. |