Deenanath Mangeshkar Hospital & Research Centre

Research Division, 6th Floor, C4, Erandawane, Pune 411004.

Tel No: 20 4015 1149/50

Email:research@dmhospital.org

1

Abbreviations

DMHRC Deenanath Mangeshkar Hospital and Research Centre

IEC Institutional Ethics Committee

SIRO Scientific & Industrial Research Organization

DSIR Dept. of Scientific & Industrial Research

CCPR Core Committee for Promotion of Research

SOP Standard Operating Procedure

SAC Scientific Advisory Committee

SACIR Scientific Advisory Committee for Integrated Research

CRO Contract Research Organization

Preface

Research your idea. See

if there's a demand. A lot

of people have great

ideas, but they don't

know if there's a need for

it. You also have to

research your

competition.

Magic Johnson

Message by Medical Director A great treatment offers benefit to an individual

patient and a good hospital should provide such

good treatment to multitude of patients. A good

research offers solutions to millions of patients

across the globe and is a far more powerful tool

for serving patients than just good treatment

alone. A great hospital must offer quality

research and hence contribute towards

improvements in treatment options. Deenanath

Mangeshkar Hospital is committed to make this

transition to a great hospital by undertaking

Clinical Research. As a part of management of

Deenanath Mangeshkar Hospital we are firmly

committed to this research endeavor .

Medical Director

Deenanath Mangeshkar Hospital and

Research Centre.

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Scientific & Industrial Research Organization (SIRO) &

Dept. of Scientific & Industrial Research

(DSIR), Government of India, New Delhi.

Research division started in 2002. Research @ DMHRC provides admin support to

Institutional Ethics Committee (IEC) and makes sure that the Regulatory

requirements are met by the principal Investigator of the Sponsored Clinical Trials

& In-house research studies.

Promotes and encourages in-house research in one pathy as well as more than one

pathy.

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Recognition by

IERC- 2004

Research co-ordination department in 2002

SAC - 2005

SOP-May2007

CCPR-2008

Dept of Research-2009 SIRO accreditation - 2009

Regulation and Facilitation Dept- 2010

Renewal of SIRO Accreditation -2011

Growth of Research Department

Regular Training started from 2011

January 2012: Quarterly News letter

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Partnership with Quintiles for Sponsored Clinical Trials (2012).

Research Infrastructure

(1) State of Art Laboratory and diagnostic facilities – Our Pathology and Microbiology

laboratory is accredited in accordance with ISO 15189:2007 standard by National Accreditation

Board for Testing and Calibration Laboratories (NABL), Dept. of Science & Technology, Govt. of

India. Other diagnostic facilities include imaging (1.5 Tesla MRI, 64 slice CT scan, USG, digital

radiology etc.) and imaging for cardiovascular purposes viz. Color Doppler, 2 D Echo and cardiac

cathlab. 12-lead ECG is available.

(2) Telecommunication - Dedicated high speed telecommunication facilities including internet

and videoconferencing in addition to conventional telephonic and fascimile (fax) transmission.

Medical Records - Facility to Archive Medical Records. Striving towards making the medical

record system paperless (electronic).

(3) Good Human Resource Development & Administrative Set Up - ‘Green channel’ for

clinical trial participants - Express registration, check-in, check-out and utilization of diagnostic

facilities.

(4) Strong patient referral network-

Primary source - Clientele of DMHRC from Pune city and adjoining town and districts

Secondary source - Referral via network of associates (physicians & general practitioners).

(5) Excellent Service provider - By maintaining high standards through recruitment and retention

of excellent staff, physicians, dentists and volunteers.

(6) SPSS software and expert guidance from Senior statisticians

(7) End note soft ware

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Contact information

Assistant Director, Research

(020 6602300 Extn 1150)

Sponsored Clinical

Trials

CCPR

(For Promotion of Basic

In house Research)

SAC –IR

(For Promotion of

Integrated Research,

In house projects)

Research officer

Admin Assistant

(020 6602300 Extn 1671)

Research Associate

(020 6602300 Extn 1652)

Research Associate

(020 6602300 Extn 1149)

E mail: research@dmhospital.org

In House studies

Department of Research: Functions

DEPARTMENT OF RESEARCH

Facilitation Regulation Research services

Assistant director & HOD of research

department

Receive all

study related

documents

Communicate

with PI and

CRCs and

Sponsors

Review and evaluate

documents ensuring regulatory

compliance as per ICH-GCP,

WHO, Schedule Y and ICMR

guidelines.

Conducts sub committee and

ethics committee meetings.

Encourages In-House research

Help in writing protocols

Designing of Questionnaire

Sample size

Data Analysis

Interpretation of results

provide help with writing

manuscripts, case studies

Training

Monitor ongoing sponsored and In-house

trials / studies

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2 18

19

34

64

7772

6152

0

20

40

60

80

100

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

An overview of Sponsored Clinical Trials

1

8

3

6

4

6

1

7

3

2

3

8

0

1

2

3

4

5

6

7

8

9

May

June

July

Aug

ust

Sep

tmbe

r

Octobe

r

Nove

mbe

r

Dece

mbe

r

Janu

ary

Febru

ary

Mar

chApr

il

Figure 2a: Percent of Trials from year 2002 – 2012

Figure 1a: No of Trials per month

333344455

55

6

7

10

1113

51

CHILTERN INTERNATIONAL PVT.LTD. CLINIVENT RESEARCH PRIVATE LIMITED

Parexel International GMBH. PHARM-OLAM INTERNATIONAL

CLINIRX I 3 Research

IGate Clinical research international Icon clinical research

PHARMANET PPD INTERNATIONAL

PRA International SIRO CLINPHARM PVT.LTD

Covance India pharmaceutical services private ltd. LAMBDA THERAPEUTIC RESEARCH LTD.

RELIANCE CLINICAL RESEARCH SERVICES Max Neeman Medical International

Quintiles Research India Pvt.Ltd.

Figure 2b: No. of Trials by CROs from 2002 to 2012

Figure 1b: No. of sponsored Clinical Trials by Specialty

22

5

8

45

8

0

5

10

15

20

25

Onco

logy

Endocrin

ology

Psych

eatry

Neurolo

gy

Cardio

logy

Oth

ers

Ma

y 2

011

to

Ap

ril

20

12

(Yea

r 20

02

– 2

01

2)

In-house studies @ DMHRC May 2011 to April 2012

Figure 3: % of completed and ongoing In-house studies from 2008 to 2012.

Figure 4: Number of In house studies Ongoing and started from May2011 to April 2012

Out of 57% of

ongoing studies, 43%

were approved &

started during April

2011 – May2012.

(Out of these 2

studies are complete).

Complete - 44

Ongoing (Approved 5/11-

4/12) - 43%

Ongoing (before

5/11) - 57% Ongoing

1 11

1

1

1

1

11111

2

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Dentistry Endoscopy Genitics ICU Medicine Memory Clinic Microbiology

Oncology Opthalmology Pathology Rhumatology SAC_IR Research Orthopedic

Laparoscopic anterior colpopexy for vaginal vault prolapse. Dr. Ameya Sameer Kanakiya, Dr. Vasanti

Doctor, Dr. Asha Gokhale.

A first attempt at doing an anterior colpopexy forvaginal vault prolapse with the use of mersilene tape

under laparoscopic guidance. This surgery can be performed with minimum laparoscopic skills. It has the

advantages of being comparatively easy to perform, being less invasive and having a faster recovery.

Presentation at the 27th Annual Conference of AICC RCOG March 2012

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'First Trimester Bleeding in Singleton Pregnancy - Correlation with Obstetric & Perinatal Outcome Dr.

Priyanka Sara, Guide: Dr. Anuradha Wakankar

OBJECTIVES: To find the prognostic factors in patients with first trimester bleeding with singleton pregnancy.

To compare the impact of light bleeding against heavy bleeding on the outcome of pregnancy.

To evaluate significance of intrauterine hematoma in threatened miscarriage. METHODOLOGY: Antenatal

patients with symptoms of first trimester vaginal bleeding at Deenanath Mangeshkar Hospital, from Feb 2009 to

Oct 2010 were enrolled for study. These patients were divided into light bleeders and heavy bleeders after

quantifying their blood loss. The outcome of pregnancy was divided into 2 groups- Miscarriage and Continuation

of pregnancy. RESULTS: The adverse prognostic factors associated with miscarriage were heavy bleeding and

pain while demonstration of cardiac activity was a favorable prognostic factor. There was no correlation between

the maternal age, parity, the gestational age, H/O PCOS, hypothyroidism, intrauterine hematoma and the

miscarriage rates. For the pregnancies which continued, heavy bleeding in the first trimester was associated with

increased risk of preterm delivery, APH, LBW and babies requiring NICU as compared to the light bleeding.

Conclusion: Heavy bleeding in the first trimester of pregnancy significantly increases the risk of miscarriage and

is associated with suboptimal outcome in the pregnancies which continue beyond the period of viability. The

presence of small intrauterine hematoma does not worsen the outcome of the pregnancy.

Presentation at Critical Care Conference,

Pune, (2012)

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Nonhematological organ dysfunction and positive fluid balance are important determinants of outcome in adults with severe dengue infection: a multicenter study from India. Schmitz L, Prayag Sm Varghese S Jog S, Bhargav-Patil P, Yadav Am Salunke D, Vincent JL. Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Belgium. PURPOSE: The purpose of the study was to explore determinants of outcome in adults with dengue hemorrhagic fever or dengue shock syndrome. METHODS: We performed a multicenter, retrospective, observational study over a 2-year period in 3 intensive care units (ICUs) in Pune (India). RESULTS: One hundred eighty-four adult patients were admitted to the ICU with a positive dengue immunoglobulin M test result; 43 met the World Health Organization criteria for dengue hemorrhagic fever or dengue shock syndrome. One patient who was transferred to another hospital and whose outcome was unknown was not included in the analysis. Of the 42 patients, 20 (48%) had multiorgan failure on ICU admission. The ICU mortality was 19% (8/42). Nonsurvivors were more likely than survivors to have cardiovascular (100% vs 12%), respiratory (88% vs 12%), or neurological (75% vs 12%) failure (all P < .01). Hematological failure was not associated with a higher risk of death. Cumulative fluid balance at 72 hours was more positive in nonsurvivors than in survivors (6.2 vs 3.5 L, P < .05). Serum albumin concentrations at ICU admission were lower in nonsurvivors than in survivors (2.9 ± 0.3 vs 3.4 ± 0.7 g/dL, P < .05).

Work shop: Study Design by Dr. Veena Joshi

Basic Statistical Analysis by Dr. Atul Mulay

Compensation to Clinical Trial Participants

Dr. Veena Joshi, Dr. Kaveri Gavade

BACKGROUND: The issue of compensation to research

participants for injury caused while participating in the

trial has only been addressed by few researchers. The

objective of this study is to understand Principal

Investigators’ (PI) and Institutional Ethics committee

members’ (IEC) perspectives on compensation to trial

subjects. METHODS: Anonymous survey was conducted

with 25 PIs and with eight Institutional Ethics committee

(IEC) members.. RESULTS: Response rate for PIs was

68% and for IEC members was 100%. 53% of the PIs were

aware of CT compensation guidelines. When asked which

guidelines you use, only two PIs answered: ABPI and

Schedule Y guidelines. IEC members suggested that

compensation should be given throughout the life span to

the subjects in case of irreparable injury due to trial, to

compensate nominated relative in case of participant’s

death due to participation in CT, compensation should be

paid for time, effort, inconvenience, and loss of wages

particularly for phase one participants and insurance

document should be clear and explicit. CONCLUSION:

The results suggest urgent need for crystal clear guidelines

to manage the dilemma of compensation to “no fault”

injury to subjects who suffer adverse effects as a result of

their participation in clinical trials.

FERCI, Nov 2011, Mumbai

Paper presentation at Public health conference at Pune University

Effect of milk/milk product’s consumption on Holo transcobalamin, vitamin B12 and homocysteine concentrations. Naik S, Bhide V, Babhulkar A, Mahalle N

OBJECTIVE: To study the absorption of vitamin B12 present in the milk by the vitamin B12 sufficient and deficient Indian vegetarians. METHODS: Eleven male and thirty female healthy vegetarian subjects were selected and grouped into two; vitamin B12 sufficient and deficient. 600 ml. of milk was given on first day and then 400 ml per day was given for next 14 days. Plasma vitamin B12, holo transcobalamin and total homocysteine levels before and after the milk load was measured. Vitamin B12 deficient subjects were also given oral supracal (containing calcium citrate and vitamin D3) tablet on 14th day followed by 600 ml of milk (200x 3).

RESULTS: Sixteen percent from vitamin B12 sufficient and 63% from vitamin B12 deficient group were hyperhomo cystinemic. Median Holo TC concentrations were 15.1 pM and 27.7 pM in vitamin B12 deficient and sufficient groups respectively. There was significant increase in the Holo TC concentrations after the milk load in deficient group (p=.0001). Regular intake of milk increased the circulating concentration of plasma vitamin B12 (p=0.018) and reduced plasma total homocysteine (tHcy) levels (p=0.044).

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“Prevalence of Tobacco addiction and role of parents in

influencing tobacco addiction among adolescents in Pune”

Kelkar DS , Patwardhan M , Joshi VD, Gavade K.

BACKGROUND: Researchers have put forward the most

consistent finding that adolescents are significantly more

likely to smoke if their parents smoke. The objective of this

study was to find prevalence of Tobacco Addiction (TA) and

assess parental influence on Tobacco Addiction among

adolescents in Pune. METHODS: A cross sectional study

was conducted with 6577 adolescents aged 12 to 20 years

from 21 schools & junior colleges in Pune during year

2005/6. Data on socio demographic profile, family

members’ and respondents’ tobacco addiction (TA) was

collected by self-administered questionnaire. Statistical tests

used were t test, chi square test and logistic regression.

RESULTS: For 6091adolescents. average age of the

respondents was 16.1 ±1.79 years. 51% were boys. 9%

adolescents were residing in the hostel. 36% of adolescents’

family members were tobacco addicted. The prevalence of

TA was 4.2%. Association of family members’ TA with

adolescent’s TA still persisted (OR = 2.6; p<.0001) after

adjusting for gender, age and staying in the hostel.

CONCLUSION:. Upcoming studies should explore if

parents discuss tobacco-related issues with their children in

a constructive and respectful manner. This may help prevent

young people taking up smoking.

Koumudi Godbole , Manjusha Vehale , Sanjay Phadke Survey among psychiatrists regarding

psychotropic drug use in reproductive age women, Asian Journal of Psychiatry Volume 4, Issue, 4, December 2011, Pages 272–276.

Sanjeev V Mangrulkar, Shubhalakhmi Mangrulkar, Pushkar Khair, Anjali Phalke Antibiotic Use in the Intensive Care Unit, JAPI • April 2012 • VOL. 60

SA Patwardhan, S Joshi Laboratory diagnosis of spinal tuberculosis: Past and Present ArgoSpine News & Journal Volume 23, Number 3, 120-124, DOI: 10.1007/s12240-011-0023-9.

SA Patwardhan, P Bhargava, VM Bhide, DS Kelkar A study of tubercular lymphadenitis: A comparison of various laboratory diagnostic modalities with a special reference to tubercular polymerase chain reaction, Indian Journal of Medical Microbiology Year : 2011 | Volume : 29 | Issue : 4

Dr. Vaishali Deshmukh, Dr Chetan Deshmukh Achieving good glycemic control effective use of self monitoring of blood glucose (SMBG) Journal of Indian Medical Association Volume 110 No 3:March 2012.

Dr. Vaishali Deshmukh Archibalds Metacarpal sign Indian Journal Of Endocrinology and Metabolism / May-June 2012/ Volume 16/ Issue 3

Publications of In-house studies

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Grants awarded by DMHRC for various projects

Name of PI Name of Project

Dr. Chetan Deshmukh Tolerability and efficacy of indigenously developed nanoparticle paclitaxel in Indian patients: A Single institution experience

Dr. Sadananad Naik The development of an elisa method for the measurement of plasma methyl malonic acid

Dr. Sameer Datar To study the enucleated eyeballs (from eye bank) rejected due to septicemia and / or malignancy, for microbilogy and histopathology.

Dr. P. Pairaiturkar Validation of Englishand Marathi Version of Oswetary Diasability Index among patients with low back pain

Dr. Ashish Ranade Study of morphometric characteristics of immature pedicles in Indian population

Ms Mangala Jogalekar Case Studies of Dementia Patients

Dr. Ashish Babhulkar Assessment of bony union after modified latarjet procedure.

Dr. Ashish Babhulkar Strength of subscapularis and Biceps after modified latarjet procedure.

Dr. Ashwini Joshi To determine whether once daily insulin glargine with regular insulin could provide better glycemic control after surgical procedures

than the traditional use of sliding scale Regular insulin.

Dr. Jayesh Rahalkar Prevalence of Dental caries and dental anomalies in children undergoing chemotherapy for malignant diseases

Dr. Vaijayanti Lagu - Joshi To Study the Ocular Manifestations and Their Association with Disease Activity, And Auto antibodies In Cohort of Rheumatoid

Arthritis Patients Attending Rheumatology Outpatient Clinic Of The Hospital

Dr. Sachin Hingmire

A prospective observational study to evaluate the incidence of EGFR mutation in adult Indian Patients Diagnosed with Esophageal and

gastric Adenocarcinoma

Dr. Amol Bapaye Yield of endoscopic -ultrasound (EUS) in Indian patients with unexplained acute pancreatitis

Dr. Shantanu Deshpande Anatomical and radiographic Measurements in Indian Hips

Dr. Sampada Patwardhan A study of invitro sensitivity of Cefepime + Tazobactum and other antimicrobial agents against enterobacteriaceae isolated from

hospitalised patients of a tertiary care hospital in India

Dr. Veena Joshi Reliability and validity of kidney disease quality of life short form (KDQOL- SFTM

) version 1.3 in Indian Set up- A study to be

conducted in Pune city based Hospitals.

Table 1:

Name of PI Name of Project Grant received

Dr. Sameer Jog

European Society of intensive care medicine study of

therapeutic hypothermia (32-350 C) for ICP reduction

after traumatic brain injury.

lothian Health board

Scotland Grant

Dr. Mrinalini

Moghe

Studies on alteration in spindle Assembly checkpoint

genes in Aneuploid Abortuses

CSIR Grant

Dr. Mrinalini

Moghe

Localization of MAD 2 protein on centromere of

human chromosome.

CSIR Grant

Dr. Amol Rege Evaluation of Efficacy of Iyengar yoga therapy in

chronic low back pain

AO Spine grant

Dr. Pradyumna

Pai Raiturkar

Prevalence of vitamin D deficiency and its

implications with low back pain among people

working in BPO office.

AO Spine grant

Grants Received from outside agencies

Table 2: Grants offered by Outside Agencies

Our Collaborators: Dr. Nene supports Integrated Research; Dr. Gokhale had supported Neem project.

JPSS: Five psycho-social projects, Dhavle trust : Promotion of homeopathic research

Awards received Name of the PI Name of the award received Title of the project

Dr Sameer Jog, Dr Divyesh

Patel, Dr Monika Kothari Dr

Safal Sable

CRITICARE 2012, 18th ISCCM

National conference, Pune, India. Won

the 3 rd prize in best oral presentations.

STROKE VOLUME VARIATION

GUIDED FLUID THERAPY IN

SEPTIC SHOCK With ARDS

Dr Sameer Jog, Dr Divyesh

Patel, Dr Tejal Dravid, Dr

Balasaheb Pawar, Dr Prasad

Akole, SN Dibin K. Chandran

CRITICARE 2012, 18th ISCCM

National conference, Pune, India. (Won

the 1st prize for best oral presentation

and research) - 32nd ISICEM, Brussels,

Belgium

Early Application Of High Frequency

Oscillatory Ventilation In ‘2009h1n1

Influenza’ Related Severe Ards Is

Associated With Better Outcome

Naik S, Bhide V, Babhulkar A,

Mahalle N Paper presentation

at Public health conference at

Pune University by Mrs. N.

Mahale

Winner of “Dr. C. Sita Devi Award

during 38th conference of the

Association of clinical Biochemists

Effect of milk/milk product’s

consumption on Holo transcobalamin,

vitamin B12 and homocysteine

concentrations

Dr. Priyanka Sara, Dr.

Anuradha Wakankar

Dr. Nirmala Agarwal Reproductive

Medicine Prize ” For Free Paper At the

27th Annual Conference of AICC

RCOG March 2012

'First Trimester Bleeding in Singleton

Pregnancy - Correlation with Obstetric

& Perinatal Outcome

Dr. Ameya Sameer Kanakiya,

Dr. Vasanti Doctor, Dr. Asha

Gokhale

“Dr.Mohinder Kochar Award” For Free

Paper At the 27th Annual Conference of

AICC RCOG March 2012

Laparoscopic anterior colpopexy for

vaginal vault prolapse

Table 3: Awards received from May 2011 to April 2012

Training programs conducted

Topic Date Trainer

Writing research Proposal 21/05/2011 Dr M. Dhadphale

WHO – ILAR- COPCORD

Project of Rheumatoid

Arthritis-

16/07/2011 Dr A Chopra

Qualitative Research in

Medicine

06/08/2011 Dr S Kulkarni

ICH GCP guidelines 08/09/2011 Quintiles Research

How to use SPSS software and

Neural network-

17/10/2011 Mr V Joshi

Literature Review 14/01/2012 Dr P Pairaiturker

Basic SPSS Training- 20/04/2012 Dr V Joshi

Testing Hypothesis 18/05/2012 Dr A Kanade

Table 4: Training Conducted from May 2011 to April 2012

Achievements Accreditation by Department of Scientific and Industrial Research

(DSIR): Accreditation was granted for two years in 2009. It has been

extended for three years in 2011.

Promotion of Research by assisting other departments at DMHRC in

terms of designing questionnaire, conducting the study, data collection,

analysis, interpretation, and writing manuscripts.

Number of in-house projects increased by 54% between 2011 to 2012 as

compared to previous years.

- Number of papers published: 5

- Number of papers accepted for publication: 2

News paper article on Awareness of Breast Cancer (Date: Maharashtra

Times)

What next….?

• Enhance core competencies of research staff

• Increase research culture and awareness

• Improve Quality of research studies

• National and International grants for research studies

• Research Collaboration with other hospitals/Institutions

• Further impetus of Integrated Research

• Conference on Ethics and Regulation has been planned during

early 2013.