1. RECENT TRENDS IN CLINICAL RESEARCH
DR. CHANCHAL GOSWAMI
Medical Director
B.P. Poddar Hospital & Medical Research Ltd.

2. WHY CLINICAL TRIALS??
Clinical trials are experiments to determine the value of treatments.
Present day principles of treatment – no more based on “GUT FEELING” or “PERSONAL EXPERIENCE”
Practically, every single modality of treatment in every speciality today – based on “EVIDENCE BASED MEDICINE”.
Clinical Trials are needed to generate ‘EVIDENCE”

3. LEVELS OF EVIDENCE IN MEDICINE: Level I: Evidence obtained from at
least one properly designed
randomized controlled trial.

4. Level II: Evidence obtained from well designed controlled trials without randomization.
Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

5. Overview of Clinical Trials in India
Total Investment in Clinical Trials in India (McKinsey’s estimates): In 2002 – $ 70 million
Future Projections By about $ 200 million By about $ 1 billion.

6. Why India as a Destination for Clinical Trials.
Huge population suffering from a vast no. of various diseases, i.e. a High Disease Load
??Less Stringent Rules and Regulations + about 60 – 70% cheaper compared to Western Countries to conduct a trial.

7. About 200 – 250 investigators already well trained in Good Clinical Practice.
Nearly 150 hospitals have adequate infrastructure to conduct clinical trials.
Availability of English speaking, well trained man power to conduct the trials.

8. PITFALLS OF A CLINICAL TRIAL
Human “GUINEAPIGS”????
Medical COLONIALISM ???

9. Phases of a Clinical Trial
Phase I Trials – Earliest trials in the life of a new drug/treatment.
Done to find out: a. The Safe dose range b. The Side Effect c. How the body copes with the drug d. If the treatment has its desired effects.

10. against c. More about side effects & their
Phase II Trials: Are done to find out: a. If the new treatment works well enough to be sent to Phase 3 b. Which types of cancer is it effective
against c. More about side effects & their
management d. More about the most effective dose to
use

11. Phase III Trials : Usually compare new treatment with the current standard treatment
May compare: a. A completely new treatment with
standard treatment b. Different doses/ways of giving a standard treatment c. A new radiotherapy schedule with a standard one.

12. Phase IV Trials: Done after a drug has been shown to work & granted a licence.
Objective: To find out a. More about side effects & safety b. Long term risks and benefits c. How well the drug works when it’s
used more widely than in clinical trials.

13. PREREQUISITES OF A CLINICAL STUDY
Feasibility
Medico-legal and Ethical Issues.
Appraisal of Clinical Efficacy and Safety
Approval by the Ethics Committee

14. BASIC PLAN OF ALL STUDIES
INFORMED CONSENT + FULL APPRAISAL OF THE PATIENTS AND THEIR RELATIVES REGARDING THE STUDY
INCLUSION AND EXCLUSION CRITERIA EVALUATION
SCREENING TEST & BASELINE EVALUATION – CLINICAL, BIOCHEMICAL, RADIOLOGICAL
DRUG ADMINISTRATION
PERIODIC ASSESSMENT

15. COMPLETED CLINICAL STUDIES : 1
“A Multicenter, Phase II Study of Cremophor Free, Polymeric, Nanoparticle Formulation of Paclitaxel (DO/NDR/02) in locally advanced and Metastatic Breast Cancer”

16. COMPLETED CLINICAL STUDIES : 2
“A Multi-Centric, Open Label, Phase- III clinical trial to evaluate the safety and efficacy of recombinant interleukin-2 in patients with metastatic renal cell carcinoma, followed up to 6 months for survival”

17. ON-GOING STUDY - 1
A Multicentric Phase III Study to evaluate “Palonosetron and Ondansetron in chemotherapy induced nausea and vomiting”.
Objective: To assess and compare the safety and efficacy of Palonosetron and Ondansetron in moderately emetogenic chemotherapy.

18. ON GOING STUDY – 2
A RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, MULTICENTRE PHASE III STUDY COMPARING THE EFFICACY & TOLERABILITY OF FULVESTRANT (FASLODEXTM) 500mg WITH FULVESTRANT (FASLODEXTM) 250 mg IN POST MENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE ADVANCED BREAST CANCER PROGRESSING OR RELAPSING AFTER
PREVIOUS ENDOCRINE THERAPY

19. ONGOING STUDY - 3
XM01-21 (PLATINUM CONTAINING CHEMOTHERAPY / SOLID TUMOURS) EFFICACY & SAFETY OF XM01 COMPARED TO PLACEBO AND EPOETIN BETA IN PATIENTS WITH SOLID TUMOURS RECEIVING PLATINUM-CONTAINING CHEMOTHERAPY, A MULTINATIONAL, MULTICENTRE, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, DOUBLE-BLIND, PARALLEL-GROUP PHASE III STUDY

20. ONGOING STUDY - 4
XMO1-22 (nonplatinum chemotherapy / solid tumours & non-myeloid haematological tumours) Efficacy & Safety of XMO1 compared to placebo in patients with solid tumours or non-myeloid haematological tumours receiving non-platinum chemotherapy, A multinational, multicentre, randomised, placebo-controlled, double-blind, parallel-group phase III study.

21. ON-GOING STUDY - 5
XMO1-23 (Haematologic Malignancies NHL, CLL, MM). Efficacy and safety of XMO1 compared to placebo in anaemic patients with low grade non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or multiple myeloma receiving anticancer therapy. A multinational, multicentre, randomised, placebo controlled, double-blind parallel-group phase III study.

22. UPCOMING STUDIES - 1
“AN OPEN-LABEL TWO ARM RANDOMIZED PHASE II STUDY OF TWO DIFFERENT DOSING REGIMENS OF CAPECITABINE IN COMBINATION WITH INTRAVENOUS DOCETAXEL (Q3W) IN PATIENTS WITH 1ST LINE ANTHRACYCLINE FAILURE, LOCALLY ADVANCED AND / OR METASTATIC BREAST CANCER”

23. UPCOMING STUDIES - 2
PHASE II, MULTICENTER, OPEN LABEL STUDY OF SLITTM (SUSTAINED RELEASE LIPID INHALATION TARGETING) CISPLATIN BY INHALATION IN THE TREATMENT OF PATIENTS WITH BRONCHOALVEOLAR CARCINOMA (PROTOCOL NO.T01-202)

24. UPCOMING STUDIES: 3 “AN OPEN LABEL, COMPARATIVE,
RANDOMIZED, MULTICENTER STUDY
TO DETERMINE EFFICACY AND
SAFETY OF DRF7295 AND FOLFOX4
COMBINATION AS FIRST LINE
THERAPY IN PATIENTS WITH
LOCALLY ADVANCED AND / OR
METASTATIC COLORECTAL CANCER”.

25. UPCOMING STUDIES: 4 “A RANDOMIZED PHASE III STUDY OF
ALIMTA ® (PEMETREXED) AND
CARBOPLATIN VERSUS ETOPOSIDE
AND CARBOPLATIN IN EXTENSIVE-
STAGE SMALL CELL LUNG CANCER ”.

26. UPCOMING STUDIES: 5
A Multicenter, Randomized, Double Blind, Placebo- Controlled, Parallel- Arm Study of the Effect of Intravenous AVE0005 (VEGF Trap) Administered Every 2 weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites.”

27. UPCOMING STUDIES: 6
A Randomized, Open Label Multi-center study of Single Agent Larotaxel (XRP9881) at 90 mg/m2 every 3 weeks Compared to Continuous Administration of 5-FU For the Treatment of Patients with Advanced Pancreatic Cancer Previously Treated With A Gemcitabine- Containing Regimen”.

28. Clinical Research Team
Investigators
Dr. Chanchal Goswami
Dr. Anil Poddar
Dr. Litan Naha Biswas
Dr. Maitrayee Bhattacharya
Dr. Prasenjit Chatterjee
Dr. Tapti Sen
Study Co-ordinators
Dr. Aniruddha Bhattacharya
Dr. Piyush Kedia
Dr. Srabani Mittal
Dr. Bikas Pal
Dr. Koyel Das
Clinical Research Assistant : Gargi Roychowdhury
Medical Records Incharge: Anindya Chakraborty
Librarian: Partha Protim Das
Study Nurse : Purnima Sen