Clinical Trials In India Research Articles

A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis

Background/objectivesTo assess the efficacy and safety of pancreatin (pancrelipase) enteric-coated minimicrospheres (MMS) over a one-year period in patients with pancreatic exocrine insufficiency (PEI) due to chronic pancreatitis (CP). MethodsThis was a 51-week, open-label extension (OLE) of a one-week, multicenter, double-blind, randomized, placebo-controlled trial in India that enrolled patients ≥18 years of age with confirmed PEI due to CP. Patients received pancreatin (Creon® 40000 MMS™) at a dose of 80,000 Ph. Eur. lipase units with each of three main meals/day and 40,000 with each of up to three snacks/day. ResultsOf 61 patients entering the OLE, 48 completed treatment (nine were lost to follow up, two withdrew consent, one discontinued due to adverse event [acute exacerbation of CP], one protocol violation). There were significant improvements from baseline to end of OLE in mean ± SD coefficient of fat absorption (CFA: 22.7 ± 12.2%), coefficient of nitrogen absorption (CNA: 6.5 ± 7.9%), body weight (4.9 ± 4.9 kg), BMI (1.9 ± 1.9 kg/m2), and most nutritional laboratory parameters tested (p ≤ 0.001). Mean daily stool frequency was reduced from 2.8 to 1.6 (p < 0.001). Improvements in clinical symptoms, clinical global impression of disease symptoms, and quality of life were also observed. Treatment-emergent adverse events (TEAEs) were observed in 64% of patients overall. Only 13% of patients experienced TEAEs judged treatment related. ConclusionsIn patients with PEI due to CP, treatment with pancreatin for one year was associated with significant improvements in fat absorption, nitrogen absorption, and nutritional parameters, improvements in clinical symptoms, and a favorable safety and tolerability profile.

Clinical trials in India: Where do we stand globally?

Aims:To evaluate the trend of clinical trials in India over the last 4 years compared to the well-established countries using clinical trial registries since the advent of clinical trial registry of India (CTRI).Materials and Methods:The data of clinical trials registered in India, United States (US), and European Union (EU) were obtained from websites of CTRI, clinicaltrial.gov and EU clinical trial registry, respectively from July 20, 2007 to August 29, 2011 for a period of 4 years. Trials registered in Australia, Canada, China, and Japan were obtained from WHO's international clinical trial registry platform for the same period. We used search words for the common diseases such as diabetes, hypertension, etc.,Results:The total number of clinical trials registered during the study period was 67,448 across seven study nations. Clinical trials from India constituted only 2.7% of the total number of trials carried out, compared to US constituting 47% of the total number of trials registered, followed by 18% from EU and 11% from Japan. However, India, China, and Japan have been found to show an increase of 3.7%, 5.1%, and 13.1% increase in the number of trials registered in 2011 compared to 2007. In contrast, US and EU showed a decline of 11.3% and 11.95% respectively in the total number of trials registered in 2011 compared to 2007.Conclusions:Although India shows gradual increase in trials registered since the advent of CTRI, still it continues to lag behind established countries in clinical research.

Injury and death in clinical trials and compensation: Rule 122 DAB.

Three amendments to the drugs and cosmetics rules were published in quick succession in 2013. These addressed the issues of compensation of injury and death in clinical trials in addition to the role and registration of Ethics Committees. Of the three, the first and the third make an impact on the clinical research activities in India. The second amendment has codified the conduct of clinical trials, putting together rules, which appeared in different sections of Schedule Y. The first amendment deals with the compensation for injuries and deaths taking place during clinical trials while the third deals with registration of Ethics Committees. Despite the long delay in the issue of compensation rules, there appears significant room for improvement. The most problematic are conditions of injury and death in which compensation has to be paid. When compared with other countries, the Indian rules seem unduly harsh on sponsors and are at significant variance with those in UK. The rules are very generous toward subjects and compensation is likely to become an alternative to insurance in terminally ill subjects. The implementation of these rules will make clinical trials in India more expensive and hurt the industry that is already struggling through other handicaps. There is an urgent need to make the the environment more industry friendly to attract more clinical work.

Feasibility study of clinical trial for breast cancer and lung cancer at Indian sites

Objective:The objective of this study was to conduct feasibility study of phase III breast and lung cancer clinical trials in India.Materials and Methods:Study synopsis and feasibility questionnaire were mailed to 300 oncologists for each indication. Criteria of selection were enrolment of ≥2 patients per month, frequency of Ethics Committee (EC) meeting ≤4 weeks, dropout rate <20%, adequacy of infrastructure and training of site in good clinical practice (GCP). Descriptive analyses of the data were performed.Results:For both indications, 50/300 (16.7%) sites responded. The median number of patients seen by a site per month for breast and lung cancer was 20 (range 0-300) and 10 (range 0-75), respectively. Median number of eligible patients was 4 (range 0-20) and 3 (range 0-15) per month, for breast and lung cancer respectively. The frequency of EC meeting was ≤4 weeks at 36-56% of sites. All sites were trained in GCP and had adequate infrastructure to conduct the clinical trial. For breast cancer 22 (44%) sites (public 14 [28%]; private 8 [16%)]), and for lung cancer 18 (36%) sites (public 15 [30%], private: 3 [6%]) met the criteria of selection.Conclusion:Preliminary feasibility study would require for confirmation of the important feasibility criteria by in depth discussion during the personal visit to the potential sites.

Positive Vibes from the Drug Regulatory Authority of India

After many reported incidences of deaths related to clinical trials in India, the Supreme Court of India recently pulled up the Ministry of Health, forcing it to come out with new strategies. New amendments have been inserted in the Drug and Cosmetic Rules, thus giving a hope that soon the scenario will improve. This short discussion reviews these amendments and their potential outcomes.

Causality assessment: A casualty of compensation?

Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of causality assessment. This could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment.

Clinical Trial in India: Searching for a Humane Face

Clinical Trial in India: Searching for a Humane Face

How to register a clinical trial in India?

How to register a clinical trial in India?

Challenges in launching multinational oncology clinical trials in India

In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is of advantage to Indian healthcare system in general, and cancer patients in particular. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country. In this article, the authors investigate the reasons for this discrepancy, highlight critical bottlenecks, and propose ways to ameliorate the situation.

Global Randomized Trials: The Promise of India and China

Although modern clinical trials are traditionally conducted in Western countries, currently there is a shift to involve developing countries, particularly China and India. For these trials, the large population size of India and China means that substantial numbers of individuals affected by rare diseases may be found, increasing the likelihood of successfully completing enrollment in a clinical trial. Furthermore, the increasing involvement of Asian countries in global clinical trials is likely to lead to greater appreciation of the value of evidence-based treatment decisions in the region. These sites are more cost-effective, although this advantage is being eroded over time. Asian participants in clinical trials are also typically more likely to complete study follow-up and procedures, and to adhere to their randomized treatment allocation than individuals from Western countries. Challenges include relevance of the proposed trial to the region, capacity limitations because of undeveloped training, and ensuring research implementation quality and different intellectual property practices. There are specific challenges to conducting clinical trials in India, such as the status of ethics committees, health insurance and coverage for participants, and variability in languages and record-keeping. Challenges in both countries are substantial but are able to be managed with appropriate planning.

System for Compensating Persons Injured in Clinical Trials in India to Be Established

System for Compensating Persons Injured in Clinical Trials in India to Be Established

Putting patients first: draft guidelines for compensation for research-related injury in clinical trials in India

Putting patients first: draft guidelines for compensation for research-related injury in clinical trials in India

Regulation failing to keep up with India's trials boom

Regulation failing to keep up with India's trials boom

INSIDE INDUSTRY

AtCor Signs US$0.9 Million Pharmaceutical Contract. Corning Opens Life Sciences Manufacturing and Distribution Facility in China. Roche NimbleGen and BGI Develop Advanced MHC Region Capture Technology. GVK Biosciences Partners with PROOF Centre of Excellence. Stemade Biotech Unveils Dental Stem Cell Banking in Chandigarh. Israeli Firm to Hold Schizophrenia Clinical Trial in India. Quintiles and Prodia Partner to Provide Central Lab Testing Solution in Indonesia. Medtronic Begins Transcatheter Aortic Valve Trial in Japan. Intellect Neurosciences Obtains Two New Patents in Japan for Alzheimer's Immunotherapy Programs. ASLAN Pharmaceuticals and Bristol-Myers Squibb Enter Innovative Oncology Partnership.

Trial by Error? A Comment on the Need for Compensating Participants for Research Related Injuries in Clinical Trials in India

This Working Paper is an attempt to carve out the arguments for providing compensation to the victims of research related injuries of clinical trials in India. The paper examines moral as well as legal arguments to argue for the provision of a no fault liability compensation scheme for any such injury sustained. Furthermore, an attempt has been made to critically assess the Draft Guidelines of ICMR on providing compensation to such participants in India.

Realizing the Promise: India’s Strategic Shift from Outsourcing to Innovation

Over the last decade the exclusive domain of pharmaceutical and biotechnology companies located in Western Europe and the United states have entered an era where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. Major issues being, the requirement to reduce the escalating costs and risks associated with drug development; and reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. In recent years there is drift; because the amount of clinical research and development activities conducted in emerging and non-traditional geographies has shown significant growth. The industry has recognized the opportunities and advantages that exist by conducting clinical trials in India; what is referred as the emerging market. As a result, many companies have flocked to India for better access to patients, lower costs and operational efficiencies. This article discusses the variety of factors that are behind the India's transformation from a simple outsourcing destination to a potential hub of true clinical research growth and innovation.

Pharmacovigilance for clinical trials in India: Current practice and areas for reform

Keeping in mind India’s increasing participation in multinational trials, this article explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Internal discrepancies exist between Schedule Y and Central Drugs Standard Control Organisation approval letter regarding what to report. Schedule Y’s silence on expedited reporting requirements creates confusion for Indian sites that are part of multinational trial. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, Indian regulators are not yet insistent on real-time update of a drug’s cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing pharmacovigilance guideline for India, in sync with global practice cannot be overemphasized.

The Year Ahead: An initiative to assess the impact of an intervention "Speaking Book" on awareness among the potential participants about clinical trials in India

The Year Ahead: An initiative to assess the impact of an intervention "Speaking Book" on awareness among the potential participants about clinical trials in India

Quality of independent review board/ethics committee oversight in clinical trials in India.

Quality of independent review board/ethics committee oversight in clinical trials in India.

Patient protection in clinical trials in India: Some concerns

Patient protection in clinical trials in India: Some concerns