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

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Presentation on theme: "RECENT TRENDS IN CLINICAL RESEARCH DR. CHANCHAL GOSWAMI DR. CHANCHAL GOSWAMI Medical Director B.P. Poddar Hospital & Medical Research Ltd."— Presentation transcript:

1 RECENT TRENDS IN CLINICAL RESEARCH DR. CHANCHAL GOSWAMI 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. Clinical trials are experiments to determine the value of treatments. Present day principles of treatment – no more based on “GUT FEELING” or “PERSONAL EXPERIENCE” 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”. Practically, every single modality of treatment in every speciality today – based on “EVIDENCE BASED MEDICINE”. Clinical Trials are needed to generate ‘EVIDENCE” Clinical Trials are needed to generate ‘EVIDENCE”

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

4 Level II: Evidence obtained from well designed controlled trials without randomization. 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. 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 Total Investment in Clinical Trials in India (McKinsey’s estimates): In 2002 – $ 70 million Future Projections By about $ 200 million By about $ 1 billion. 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 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. ??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. About 200 – 250 investigators already well trained in Good Clinical Practice. Nearly 150 hospitals have adequate infrastructure to conduct clinical trials. Nearly 150 hospitals have adequate infrastructure to conduct clinical trials. Availability of English speaking, well trained man power to conduct the trials. Availability of English speaking, well trained man power to conduct the trials.

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

9 Phases of a Clinical Trial Phase I Trials – Earliest trials in the life of a new drug/treatment. 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. 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 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 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 against c. More about side effects & their management d. More about the most effective dose to management d. More about the most effective dose to use use

11 Phase III Trials : Usually compare new treatment with the current standard treatment Phase III Trials : Usually compare new treatment with the current standard treatment May compare: a. A completely new treatment with 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. 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. 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 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. used more widely than in clinical trials.

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

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

15 COMPLETED CLINICAL STUDIES : 1 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” “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 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 ON-GOING STUDY - 1 A Multicentric Phase III Study to evaluate “Palonosetron and Ondansetron in chemotherapy induced nausea and vomiting”. 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. 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 (FASLODEX TM ) 500mg WITH FULVESTRANT (FASLODEX TM ) 250 mg IN POST MENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE ADVANCED BREAST CANCER PROGRESSING OR RELAPSING AFTER A RANDOMISED, DOUBLE-BLIND, PARALLEL GROUP, MULTICENTRE PHASE III STUDY COMPARING THE EFFICACY & TOLERABILITY OF FULVESTRANT (FASLODEX TM ) 500mg WITH FULVESTRANT (FASLODEX TM ) 250 mg IN POST MENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE ADVANCED BREAST CANCER PROGRESSING OR RELAPSING AFTER PREVIOUS ENDOCRINE THERAPY 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 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. 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. 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 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 1 ST LINE ANTHRACYCLINE FAILURE, LOCALLY ADVANCED AND / OR METASTATIC BREAST CANCER” “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 1 ST LINE ANTHRACYCLINE FAILURE, LOCALLY ADVANCED AND / OR METASTATIC BREAST CANCER”

23 UPCOMING STUDIES - 2 PHASE II, MULTICENTER, OPEN LABEL STUDY OF SLIT TM (SUSTAINED RELEASE LIPID INHALATION TARGETING) CISPLATIN BY INHALATION IN THE TREATMENT OF PATIENTS WITH BRONCHOALVEOLAR CARCINOMA (PROTOCOL NO.T01-202) PHASE II, MULTICENTER, OPEN LABEL STUDY OF SLIT TM (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 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 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.” 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/m 2 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”. A Randomized, Open Label Multi-center study of Single Agent Larotaxel (XRP9881) at 90 mg/m 2 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 Investigators Dr. Chanchal Goswami Dr. Chanchal Goswami Dr. Anil Poddar Dr. Anil Poddar Dr. Litan Naha Biswas Dr. Litan Naha Biswas Dr. Maitrayee Bhattacharya Dr. Maitrayee Bhattacharya Dr. Prasenjit Chatterjee Dr. Prasenjit Chatterjee Dr. Tapti Sen Dr. Tapti Sen Study Co-ordinators Study Co-ordinators Dr. Aniruddha Bhattacharya Dr. Aniruddha Bhattacharya Dr. Piyush Kedia Dr. Piyush Kedia Dr. Srabani Mittal Dr. Srabani Mittal Dr. Bikas Pal Dr. Bikas Pal Dr. Koyel Das Dr. Koyel Das Clinical Research Assistant : Gargi Roychowdhury Clinical Research Assistant : Gargi Roychowdhury Medical Records Incharge : Anindya Chakraborty Medical Records Incharge : Anindya Chakraborty Librarian: Partha Protim Das Librarian: Partha Protim Das Study Nurse : Purnima Sen Study Nurse : Purnima Sen

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