Presentation on theme: "RECENT TRENDS IN CLINICAL RESEARCH"— Presentation transcript:
1RECENT TRENDS IN CLINICAL RESEARCH DR. CHANCHAL GOSWAMIMedical DirectorB.P. Poddar Hospital & Medical Research Ltd.
2WHY 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”
3LEVELS OF EVIDENCE IN MEDICINE: Level I: Evidence obtained from at least one properly designedrandomized controlled trial.
4Level 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.
5Overview of Clinical Trials in India Total Investment in Clinical Trials in India (McKinsey’s estimates): In 2002 – $ 70 millionFuture Projections By about $ 200 million By about $ 1 billion.
6Why 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.
7About 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.
8PITFALLS OF A CLINICAL TRIAL Human “GUINEAPIGS”????Medical COLONIALISM ???
9Phases 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.
10against 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 effectiveagainst c. More about side effects & theirmanagement d. More about the most effective dose touse
11Phase III Trials : Usually compare new treatment with the current standard treatment May compare: a. A completely new treatment withstandard treatment b. Different doses/ways of giving a standard treatment c. A new radiotherapy schedule with a standard one.
12Phase 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’sused more widely than in clinical trials.
13PREREQUISITES OF A CLINICAL STUDY FeasibilityMedico-legal and Ethical Issues.Appraisal of Clinical Efficacy and SafetyApproval by the Ethics Committee
14BASIC PLAN OF ALL STUDIES INFORMED CONSENT + FULL APPRAISAL OF THE PATIENTS AND THEIR RELATIVES REGARDING THE STUDYINCLUSION AND EXCLUSION CRITERIA EVALUATIONSCREENING TEST & BASELINE EVALUATION – CLINICAL, BIOCHEMICAL, RADIOLOGICALDRUG ADMINISTRATIONPERIODIC ASSESSMENT
15COMPLETED 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”
16COMPLETED 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”
17ON-GOING STUDY - 1A 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.
18ON GOING STUDY – 2A 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 AFTERPREVIOUS ENDOCRINE THERAPY
19ONGOING STUDY - 3XM01-21 (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
20ONGOING STUDY - 4XMO1-22 (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.
21ON-GOING STUDY - 5XMO1-23 (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.
22UPCOMING 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”
23UPCOMING STUDIES - 2PHASE 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)
24UPCOMING STUDIES: 3 “AN OPEN LABEL, COMPARATIVE, RANDOMIZED, MULTICENTER STUDYTO DETERMINE EFFICACY ANDSAFETY OF DRF7295 AND FOLFOX4COMBINATION AS FIRST LINETHERAPY IN PATIENTS WITHLOCALLY ADVANCED AND / ORMETASTATIC COLORECTAL CANCER”.
25UPCOMING STUDIES: 4 “A RANDOMIZED PHASE III STUDY OF ALIMTA ® (PEMETREXED) ANDCARBOPLATIN VERSUS ETOPOSIDEAND CARBOPLATIN IN EXTENSIVE-STAGE SMALL CELL LUNG CANCER ”.
26UPCOMING STUDIES: 5A 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.”
27UPCOMING STUDIES: 6A 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”.
28Clinical Research Team InvestigatorsDr. Chanchal GoswamiDr. Anil PoddarDr. Litan Naha BiswasDr. Maitrayee BhattacharyaDr. Prasenjit ChatterjeeDr. Tapti SenStudy Co-ordinatorsDr. Aniruddha BhattacharyaDr. Piyush KediaDr. Srabani MittalDr. Bikas PalDr. Koyel DasClinical Research Assistant : Gargi RoychowdhuryMedical Records Incharge: Anindya ChakrabortyLibrarian: Partha Protim DasStudy Nurse : Purnima Sen