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The Drugs Controller General of India (DCGI) has constituted an Independent Expert Committee on Oncology for examination of reports of serious adverse events (SAEs) of deaths occurred during clinical trials in the country. Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College, New Delhi is the chairman of the expert committee.
The committee will function under the provisions as specified in Appendix XII of the Schedule Y of the Drugs & Cosmetics Rules.
The chairman of the committee will receive reports of serious adverse events of death from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and the ethics committee. The committee will examine the reports of serious adverse events of death, to determine the cause of death and if the cause is due to reasons which are considered as clinical trial related death , then it will give its recommendation to the DCGI.
The committee will examine whether the death has been happened due to adverse effect of investigational products; due to violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; whether it is due to the failure of investigational product to provide intended therapeutic effect; due to use of placebo in a placebo-controlled trial; due to adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; for injury to a child in-utero because of the participation of parent in clinical trial; and due to any clinical trial procedures involved in the study.
In case of clinical trial related death, the committee will also give recommendation to the DCGI the quantum of compensation to be paid by the sponsor or his representative.
Dr YK Gupta of AIIMS New Delhi; Dr Renuka Kulkarni-Munshi of TN Medical College and BLY Nair Charitable Hospital, Mumbai; Dr Hemant Malhotra of SMS Medical College, Rajasthan; Dr SD Banavali of Tata Memorial Hospital, Mumbai; Dr TN Sagar of Cancer Institute, Adayar, Chennai; Dr Kishore Singh of Maulana Azad Medical College, New Delhi; and Dr S Kataria of Safdarjung Hospital are the other members of the 8-member expert committee.
Pharma cos & CROs opt for cloud computing to propel competence in data integration for clinical studies
Indian pharma and clinical research organisations (CROs) are adopting cloud technology solutions to accelerate drug development, enable data compilation, create efficiency and decrease the time-to market. Following changes on the global regulatory landscape, there is an increased dependence on reliable data which has led pharma companies and CROs opt for cloud computing to nurture innovation and improve productivity, according to industry experts.
A recently concluded DIA workshop on ‘Evolving landscape of clinical data management: Focus on technology and data standard’ indicated that in the current competitive landscape, pharma industry was looking to collaborate with the clinical data management service providers to garner regulatory compliance and improve efficiency.
“Clinical research business in the country is on a revival mode and is indicating signs of growth. But the momentum of growth is still found wanting even though change is evident and perceptible. The focus is not on just clinical data management (CDM) but a shift to value-added services like medical monitoring and safety data processes. Now this will see India play a big role in the space of clinical data management projects”, Suresh Ramu, chief executive officer, Cytespace told Pharmabiz on the sidelines of the DIA workshop.
“However, the growth in clinical research particularly human studies is not exponential but steady. The way forward is mergers and acquisitions with the industry moving to a consolidation mode”, noted the Cytespace chief executive officer, in his keynote address on the ‘Interplay of technology and data standards in CDM’.
There are clear signs that global majors have recognised the indispensability of India. This has led pharma and the CROs to move on to cloud computing and analytics platforms to reduce manual errors and help achieve better quality and patient safety. Since clinical trials are a critical component of drug development, there is need to achieve seamless integration across applications to diminish data duplication, highlighted experts at the DIA workshop.
The participants like clinical data managers, clinical database programmers, bio statisticians, besides related professionals were given a lucid angle on the role of cloud technology as an innovative tool for clinical data management.
Mandar Ghatnekar, senior manager, Life Sciences Practice, Accenture in his presentation on the recent innovations in technology solutions for clinical data management said that the focus of pharma industry and the CROs was to achieve speed, functionally and collaboration. Technology trends like social media, mobility, analytics and cloud computing (SMAC) are evolving in this space.
“Particularly, cloud computing and analytics have created a seamless and scalable environment. The industry be it pharma or CROs are now seen to increasingly invest in such technologies to achieve speed to market,” he added.
A few years ago, global pharma companies were reluctant to host any data of clinical trial on an external environment. But today, all these companies and those in India are looking to increase their presence on a private cloud environment. The focus of information technology majors including SAP and Oracle is to develop life sciences software powered by analytical tools and reporting applications to enhance knowledge management, said Ghatnekar.
The apex committee set up by the Union health ministry to monitor the clinical trials sector and headed by the health secretary has cleared 21 out of the 22 fresh proposals for clinical trials, after they were recommended by new drug advisory committees and thereafter the technical committee, another high-level panel formed by the ministry.
In a recent meeting of the apex committee, 22 applications were taken for ratification after the clearance by the technical panel and the panel evaluated the cases in view of risk versus benefit to the patients, innovation vis-à-vis exiting therapeutic option and unmet medical need in the country. The committee then ratified the recommendations by the technical committee in this regard.
Out of the 22 cases came up before the technical committee, four cases of clinical trials were for new drugs, 11 cases for global clinical trials and the remaining were clinical trial proposals related to fixed dose combinations, biological and institutional trial.
In the case of study on Ifetroban by Max Neeman, the CRO, the technical committee recommended to submit the proposal along with the opinion of the pharmacologist,, though it was cleared by the NDAC. In all other 21 cases, the panel recommended the approval by the authorities.
Siro Clinpharm (N 201), Excel Life Sciences (fluocinolone acetonide intravitreal insert), Novartis (ranibizumab), Aurobindo Pharma (cyclosporine), Bicad (algeron), Maya Clinicals (masitinib mesylate), Parexel (asenapine), PPD (permapanel and E2007-perampanel) and Novartis (biosimilar adlimumab) applied for global clinical trial and got the approval.
Bharat Serums and Vaccines Ltd (recombinant human chorionic gonadotrophin), Dr Reddy’s Laboratories (rituximab), Reliance Life Science (trastuzumab), Fresenius Kabi (smofkabiven peripheral and smofkabiven), Wockhardt (nadifloxacin), Dr Pratibha D Singhi (tizanidine), Sanofi-Synthelabo India Ltd (plerixafor solution), Hetero Labs (retigabine), Zuventus Healthcare Ltd (fenspiride hydrochloride) and Glenmark Pharma (crofelemer) also got the clearance by the panels for clinical trials.
The health ministry had formed the two high-level panels to streamline the approvals to the clinical trials in wake of severe criticism by the Supreme Court on the malpractices and lethargy in the sector.
For the second year in a row, Quintiles has been named the industry leader that best differentiates itself on service quality for phase II/III research in Industry Standard Research’s (ISR) 2014 CRO Quality Benchmarking phase II/III Service Providers Report. According to the 148 pharmaceutical and biotechnology decision makers surveyed by ISR in this year’s report, Quintiles is the preferred provider for phase II/III research among small, mid-size and large biopharmaceutical companies.
“At Quintiles, we are focused on leading our customers through an increasingly complex and ever-changing drug development landscape,” said Paula Brown Stafford, president of Clinical Development at Quintiles. “We are delighted once again to be recognized as the industry leader in phase II/III research. This distinction is a result of the work of our tremendous teams around the world and underscores our unique ability to connect insights, expertise and capabilities across our organization to improve the probability of success for our customers.”
In the survey, Quintiles outperformed all other large CROs across all customer loyalty-related measures, which are defined by overall satisfaction, willingness to recommend, and likelihood to use Quintiles again
Quintiles also rated higher than all large CROs in a number of selection criteria, including: Breadth of services; Therapeutic expertise; Commercial market, local market and regulatory knowledge; Data quality; Technology for real-time data access; Speed of site start-up; Patient recruitment strategy.
Survey respondents were decision-makers with large, mid-size and small biopharmaceutical companies who were involved in outsourced clinical study activities and phase II/III clinical trials within the past 18 months. More information about the ISR report is available here.
Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 28,000 employees conducting business in approximately 100 countries.
Global CROs, intl research centres and bio pharma cos eager to include India for their human studies
Global clinical research organisations, leading international research centres and the bio pharma companies abroad are keen to conduct human studies on the Indian patient population. This is where, the union government will need to take speedy decisions on clearing the recommendations put forth by Prof. Ranjit Roy Choudhury Committee’s recommendations to kick start human studies in India.
The fact is that National Institute of Health in the US and the University of Oxford in the UK have not written off India for conduct of human studies. These countries have only suspended clinical trials in India following the Supreme Court order in early 2013 but not stopped any trial here. Recently, countries like Ukraine and Russia have also evinced interests to include Indian patient data through clinical trial studies in their global drug development programmes, Prof. Ranjit Roy Choudhury, chairman of expert committee on clinical trial told Pharmabiz.
“Therefore there is a huge genuine and visible interest for India because of the presence of medical expertise and the capability of India to conduct human studies in an ethical manner. Now the government will need to take a cue from this and take a speedy decision to bring in five changes into the clinical trials. These are low hanging fruits vital to the industry. Now if the given changes are brought in covering accreditation of the three entities clinical trial investigators, clinical trial sites and the ethics committees, training of investigators and the compensation, then we could be back on the track. What we are witnessing now is a slow paced process in the outcomes of the recommendations”, he added.
‘There is need to adopt a faster decision making process because right now the issue is the challenge of slow paced procedural approvals. However, in my view, there is already light at the end of the tunnel because the government accepted the recommendations of my Committee. But my view is that if the government takes out the five crucial recommendations and make it an office order and not wait for it to be mandated as a law then clinical trials in India could see some traction”, noted Prof. Roy.
The government has accepted all 27 of the 30 recommendations. The three proposals which were not approved are the permission to market drugs developed abroad to be allowed for marketing without having a separate data on Indian patients. This was only in the case of drugs which were found to be absolutely safe without any side effects. This is because the Committee saw it as a more progressive move and found it unnecessary to repeat a trial on those drugs which did not have any adverse reactions. The second is the audio visual recording consent which is now seen to be feasible from a government perspective only if patients were mentally challenged and for the paediatric population. The third one was to permit phase I to III trials in India. But the pharma industry had stated that some tests needed to be done abroad, stated Prof. Choudhury.
Going by the positive response from global quarters on the need to conduct clinical trials in India, Prof. Choudhury stated that government will need to hasten its stand on this.