“Data Sharing and Post study access to trial medication for study subjects are the two emerging frontiers in clinical research space,” said Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services.
Speaking at a conference on “CLINICA: Recent trends and approaches in Clinical research, Clinical trial and Medical writing” organised by ABC Biologics in Bangalore on September 1, she said “Data sharing, whether elective or required, creates an obligation for the original investigators who obtain funding, design studies, collect and analyze data, and publish results to make their curated data and associated”.
She further noted that data from well-designed and well-executed research not only are useful for the original purpose and secondary analyses by the original researcher but also can be repurposed for a variety of applications, including independent replication, avoidance of duplicative studies, generation or testing of new hypotheses, and the general advancement of clinical and biologic understanding.
Talking about Post Trial responsibilities: continued access to trial medication she observed that informed consent for continued access to medication must be obtained. “The regulations that bind this complex topic is still under evolution,” she concluded.
この記事は Bio Spectrum の October 2017 版に掲載されています。
7 日間の Magzter GOLD 無料トライアルを開始して、何千もの厳選されたプレミアム ストーリー、9,000 以上の雑誌や新聞にアクセスしてください。
すでに購読者です ? サインイン
この記事は Bio Spectrum の October 2017 版に掲載されています。
7 日間の Magzter GOLD 無料トライアルを開始して、何千もの厳選されたプレミアム ストーリー、9,000 以上の雑誌や新聞にアクセスしてください。
すでに購読者です? サインイン
Economic Survey Lays Focus On Mental Healthcare For The First Time
For the first time ever, the Economic Survey 2023-24 tabled by the Union Minister of Finance and Corporate Affairs Nirmala Sitharaman in Parliament recently, talks extensively about mental health, its significance and implications on policy recommendations.
IIT-G discovers RNA-destroying function of p30 protein in African Swine Fever Virus
Indian Institute of Technology Guwahati (IIT-G) researchers have investigated the biochemistry of the African Swine Fever Virus (ASFV) protein, focusing on understanding the biochemical processes of infection to devise effective control strategies.
13th Bengaluru INDIA NANO 2024 brings together 1018 delegates, 3,000+ visitors
The 13th edition of Bengaluru INDIA NANO 2024, organised by the Department of Science & Technology, Government of Karnataka, Karnataka Science & Technology Promotion Society (KSTePS), and Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) concluded on August 3 with participation of 1018 delegates, 11 countries including Korea, Morocco, USA, UK, France, Canada, Germany, Netherlands, Russia, Japan, and Poland, 49 exhibitors comprising 21 startups and 28 industry and institutes, and 200 posters. The exhibition had a footfall of 3,000+ visitors.
Are Nutraceuticals DRUGS? Examining a Needless Regulatory Tussle
The news has been around for a while which has put a big question mark ahead of the Indian nutraceuticals industry.
Can India Reclaim API Throne from China?
Despite having the third-largest pharmaceutical industry by volume in the world and being the largest manufacturer of generic medicines globally, India is heavily dependent on China for imports of raw materials, Key Starting Materials (KSMs), and Active Pharmaceutical Ingredients (APIs).
JRS Pharma & Gujarat Microwax open new manufacturing facility in Mehsana
JRS Pharma, a leading manufacturer of excipients, in partnership with Gujarat Microwax, has commissioned a new manufacturing facility for cotton-based croscarmellose sodium.
NovaLead's patented repurposed drug for treating DFU gets CDSCO approval
Pune-based NovaLead Pharma has announced that the drug regulator in India, Central Drugs Standard Control Organisation (CDSCO), has approved their patented Repurposed Drug for treatment of Diabetic Foot Ulcer (DFU) which is a global unmet medical need.
Medicamen Organics expands footprint in East Africa with $75,000 investment in Rwanda
Delhi-based pharma company Medicamen Organics has taken a significant step in its global expansion strategy by signing a Memorandum of Understanding (MoU) with Depot Pharmacy Yego in Rwanda.
Mankind Pharma acquires 100% stake in Bharat Serums and Vaccines for Rs 13,630 Cr
Mankind Pharma has entered into a definitive agreement to acquire a 100 per cent stake in Bharat Serums and Vaccines Limited (BSV) from Advent International, for an enterprise value of approx.
Thyrocare buys Polo Labs' pathology diagnostic biz to strengthen Northern India presence
Mumbai-based Thyrocare, a leading diagnostic and preventive healthcare service provider in India, has entered into a Business Transfer Agreement with Polo Labs to acquire their pathology diagnostic business.