Latest news with #GoodClinicalPractice
Time of India
21-04-2025
- Health
- Time of India
Documents reveal modus operandi of illegal clinical trials at VS Hospital
Ahmedabad: How did a team of contracted doctors, along with an associate professor, collude with a city-based firm to conduct allegedly illegal clinical trials at VS Hospital, which remained undetected for four years? Fresh documents, including the clinical trial agreement (CTA) for a drug trial involving Deglusterol for an east Asian pharma company, accessed by the investigating committee, provides a clear picture. Documents accessed by TOI reveal that one such clinical trial study was titled, "A randomized, double-blind, placebo-controlled, parallel study to assess the effects of Deglusterol on fasting glucose and other cardiometabolic risk factors in patients with Type 2 diabetes mellitus" under protocol number CG-D-P02. "Protocol numbers for drug trials are assigned by the Central Drugs Standard Control Organization (CDSCO)," said a senior AMC official. "The doctors knew that an ethics committee was formed at SVP Hospital but not at VS Hospital after the 2019 split in the management. Dr Devang Rana and eight contracted doctors exploited this gap for execution," a committee member alleged. The trial was structured through a CTA involving the sponsor, an east Asian pharma company, a city-based contract research organization (CRO), principal investigator Dr Dhaiwat Shukla, VS General Hospital (the trial site), and a site management organization based out of Jagatpur. "Shukla was among the eight contracted doctors whose services were terminated in this alleged drug trial case," says The pharma firm, as the sponsor, supplied Deglusterol free of cost and delegated operational control to the city based CRO. "The CRO's responsibilities included overseeing trial execution, monitoring data collection, managing communication with the ethics committee and coordinating financial transactions with the investigator and institution," said a senior AMC official. He added, "The CRO entered into direct agreements with Dr Shukla at VS General Hospital. Dr Shukla was tasked with ensuring compliance with Good Clinical Practice (GCP) guidelines. He was responsible for submitting the trial protocol, the final CTA, insurance documents and CTRI registration to the Jodhpur -based hospital's ethics committee — designated as the approving body stated the CTA agreement." "Once enrolled, patients were administered the investigational drug in accordance with the protocol. Data related to each subject, including medical notes and trial progress, was entered into a third-party platform, with the CRO maintaining monitoring rights. The investigational drug was stored, handled and administered under the supervision of the principal investigator, and any adverse reactions were to be reported to the CRO, the sponsor and the ethics committee," the AMC official said.
Associated Press
19-03-2025
- Health
- Associated Press
Terumo Neuro Celebrates 15 Years of the WEB™ Device: A Game-Changing Innovation in Aneurysm Treatment
More than 25,000 Devices Implanted Worldwide from 2010-20251 ALISO VIEJO, Calif., March 19, 2025 /PRNewswire/ -- Terumo Neuro, a global leader in neurovascular innovation and a wholly owned subsidiary of Terumo Corporation, proudly marks the 15th anniversary of the groundbreaking WEB™ Aneurysm Embolization System. Since its introduction, the WEB device has transformed the treatment of wide-neck bifurcation aneurysms, offering physicians and patients a clinically proven, single-device solution – One and Done – with proven simplicity, proven safety and durability, proven for ruptured aneurysms* and proven innovation2-9. The WEB device was commercially launched in October 2010 after receiving its CE (Conformité Européenne) Mark in Europe. The first implant was performed by Prof. Joachim Klisch in Germany, paving the way for a new era in aneurysm treatment. The WEB device has proven clinical data, supported by seven global Good Clinical Practice (GCP) studies2-8 and over 200 peer-reviewed publications. Over the past 15 years, this revolutionary technology has changed the paradigm for aneurysm treatment, providing a safe, effective alternative to traditional methods. Carsten Schroeder, President and CEO of Terumo Neuro, commented on this significant milestone: 'The WEB device has set a new standard in aneurysm treatment and has been instrumental in our mission to drive game-changing impact in neurovascular care. With 15 years of proven clinical success, WEB continues to advance patient outcomes, reducing the need for multiple devices and lengthy procedures. As we celebrate this achievement, we remain committed to innovating alongside leading physicians worldwide to shape the future of neurovascular care.' Transforming Aneurysm Treatment with the WEB Device The WEB device is the world's first intrasaccular flow disruptor, designed to treat brain aneurysms from inside the aneurysm sac. Unlike traditional treatments for wide-neck bifurcation aneurysms that require stents and coils, this device minimizes the need for dual antiplatelet therapy, simplifying procedures and enhancing patient safety, with a single device. Key milestones and clinical highlights of Terumo Neuro's WEB embolization system include: Unparalleled Clinical Data: The WEB device has been studied in over 600 patients across seven GCP trials, accumulating more than 1,464 patient-years with zero recorded rebleeds in a WEB device-treated aneurysm.2-8 Proven Long-Term Safety & Durability: The five-year follow-up data from the WEB-IT, WEBCAST and WEBCAST 2 trials reaffirmed the WEB system's sustained efficacy and safety, including 0% device-related morbidity and mortality.7,8 Expanding Treatment Options: The introduction of the WEB 17 system, a lower profile system to treat smaller aneurysms, has further refined aneurysm treatment providing physicians with greater flexibility and precision for a wider range of cases. The WEB device's continued evolution underscores Terumo Neuro's dedication to advancing neurovascular technology. With more than 25,000 patients treated with the WEB device worldwide, this intrasaccular device remains the trusted choice for physicians seeking a reliable, single-device solution for wide-neck bifurcation aneurysms. About Terumo Neuro (Formerly MicroVention, Inc.) We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neuroendovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in California, Terumo Neuro products are sold in more than seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California, and San José, Costa Rica. For more information on Terumo Neuro, please visit About Terumo Corporation Terumo (TSE:4543) is a global leader in medical technology and has been committed to 'Contributing to Society through Healthcare' for one hundred years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large. For full indications for use, visit: WEB™ Embolization System | Terumo Neuro *Information provided may not represent the approved indication for use for each country/market. Please refer to the Instruction for Use (IFU) in the specific market/country that you are looking into. References: Data on file, Terumo Neuro. Pierot L, Moret J, Barreau X, et al. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J Neurointerv Surg. 2018;10(6):553-559. Arthur AS, Molyneux A, Coon AL, et al. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study. J Neurointerv Surg. 2019;11(9):924-930. Pierot L, Moret J, Turjman F, Herbreteau D, et al. WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory. AJNR. 2016. Spelle, L., et al. (2022) 'Clinical Assessment of WEB device in Ruptured Aneurysms (CLARYS): 12-month angiographic results of a multicenter study.' J NeuroIntervent Surg. Spelle, L., et al. (2024) 'Clinical Evaluation of WEB 17 device in intracranial aneurysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.' J NeuroIntervent Surg. Pierot L, Szikora I, Barreau X, et al. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023;15(6):552-557. Fiorella D, Molyneux A, Coon A, et al. Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular. Therapy study (WEB-IT). J Neurointerv Surg. 2023;15(12):1175-1180. Rai AT, Turner RC, Brotman RG, Boo S. Comparison of operating room variables, radiation exposure and implant costs for WEB versus stent assisted coiling for treatment of wide neck bifurcation aneurysms. Interv Neuroradiol. 2021;27(4):465-472. WEB™ is a trademark of MicroVention, Inc., registered in the United States and other jurisdictions. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties. ©2024 MicroVention, Inc. MM2034(i) WW 03/25 Media Contact: + 1 714 206 9800
Associated Press
10-03-2025
- Business
- Associated Press
Nanomerics Reports Last Volunteer Visit in the OC134 Sunlight Trial; The Sunlight Trial Met Its Primary Endpoints
Nanomerics Ltd. announced the successful completion of its OC134 Phase I trial - the SUNLIGHT trial. With the clinical phase competed the trial for OC134 and the MET platform has met its primary endpoints. LONDON, UK / ACCESS Newswire / March 10, 2025 / Nanomerics Ltd., a private speciality pharmaceutical company today announced that it had completed 28 consecutive days of administration in its OC134 Phase I trial - the SUNLIGHT trial and discharged the last volunteer from the trial. The last volunteer, last visit event concludes the clinical part of the trial. Nanomerics is pleased to report that the trial met its primary endpoints. All volunteers (n=10) completed the 28-day consecutive twice daily (12 hours apart) dosing schedule with either MET eye drops or OC134 eye drops, and all volunteers completed the 56 day follow up visits, with no dropouts. There were no treatment-related adverse events of moderate or severe severity reported during the clinical and follow-up phases of the trial and there were no treatment-related clinically significant individual changes from baseline or notable trends in safety assessments including safety bloods, vital signs, eye examination, 12 lead ECGs and urinalysis. The topical administration of MET and OC134 eye drops on 56 consecutive occasions was well tolerated by healthy volunteers under the conditions of trial and no treatment-related items of concern were reported during the follow up visits. Approval was granted for the OC134 and MET tolerability study by the UK Medicinal and Healthcare Products Regulatory Agency (MHRA) and the study was conducted by Quotient Sciences at its Nottingham, UK Phase I study site according to Good Clinical Practice guidelines. OC134 is an eye drop medicine candidate indicated for the topical treatment of moderate to severe allergic conjunctivitis, a condition for which a suitable non-steroidal topical ocular treatment, does not currently exist. OC134 is also indicated for the topical treatment of dry eye disease. OC134 is powered by Nanomerics' Molecular Envelope Technology (MET), a non-irritant ocular penetration enhancer. Nanomerics' MET is a platform ocular penetration enhancer, that has been shown in preclinical studies to increase the penetration of active pharmaceutical ingredients (APIs) into the front of the eye; increasing ocular deposition up to 18-fold, when compared to conventional formulations. In preclinical studies, Nanomerics' MET also demonstrated the delivery of APIs to the retina from eye drops. Nanomerics has a pipeline of ocular assets that may now be tested in clinical studies and ultimately launched for the benefit of patients. Nanomerics' MET is now a clinical stage ocular excipient. Professor Andreas G. Schätzlein, Nanomerics' Chief Executive Officer said, 'Our last volunteer, last visit event concludes the clinical and follow-up parts of the SUNLIGHT trial and we can now proudly state that Nanomerics is a clinical stage company, with assets applicable to a broad range of ophthalmology markets. Our goal has always been to discover and develop efficient, well-tolerated therapies for patients in areas of large unmet medical need and we embark on this new phase in our company, confident that we can deliver on this singularly important goal.' Dr Nand Singh, Medical Director at Quotient Sciences commented, We are pleased to state that the First-In-Human trial has been completed at our Nottingham, UK clinic for Nanomerics' OC134 Phase 1 SUNLIGHT trial. The trial met its primary endpoints, demonstrating favourable safety and tolerability profiles of MET and OC134 eye drops, administered as stated above, among healthy male and female volunteers. This excellent profile further warrants clinical trials in patient populations with moderate to severe allergic conjunctivitis, to further assess and achieve the critical proof of concept milestone for OC134. About Nanomerics Nanomerics Ltd is a speciality pharmaceutical company with state-of-the-art laboratories based in London, UK. Nanomerics was founded to commercialise its biocompatible polymer technologies for drug delivery and other applications. Nanomerics' proprietary technology is based on world leading know-how and scientific leadership in polymer nanotechnology. Nanomerics creates uniquely differentiated, patented pharmaceutical assets, underpinned by high quality science. For example, the company's Molecular Envelope Technology (MET) is a unique patented biocompatible polymer that delivers a step change in target tissue bioavailability. The founding scientists, Professor Dame Ijeoma F. Uchegbu and Professor Andreas G. Schätzlein developed the technology at the Universities of Strathclyde and Glasgow and, latterly at the UCL School of Pharmacy. Pharmaceutical product candidates in development include the eye drops: OC134 for the treatment of moderate to severe allergic conjunctivitis and dry eye disease, OC137 for the treatment of retinal diseases and OC135 for the treatment of glaucoma. For more information, please visit . For press enquiries contact: Pedro Margarido Head of Operations, Nanomerics Quotient Sciences Quotient Sciences is a drug development and manufacturing accelerator providing integrated programmes and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, Quotient saves precious time and money in getting drugs to patients. Everything Quotient does for its customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast, because humanity needs novel therapeutic solutions, fast. Quotient Sciences has been recognized as a multi-year winner of the CRO Leadership Awards in 2021, 2022, and 2024 and of the CDMO Leadership Awards in 2023. For more information, visit . For press enquiries, contact:
Yahoo
06-03-2025
- Health
- Yahoo
Why I'm sounding the alarm on the next puberty blockers scandal
Few issues in contemporary medicine have generated as much controversy as the use of puberty blockers in gender distressed children. The Government, responding to the findings of the Cass Review, has rightly banned the prescription of these drugs. Many other countries have, too. However the Government last week announced an £11 million clinical trial of these medicines to gather evidence of their effects. This raises a fundamental question: can a clinical trial of puberty blockers on children experiencing gender distress be done ethically? The answer, upon scrutiny, is a resounding 'no'. I have witnessed firsthand the grave dangers posed by the rush to medicalise childhood gender distress. As a former psychiatrist at the Tavistock and Portman NHS Trust, I was one of the whistleblowers who raised concerns about the practices at the now shuttered Gender Identity Development Service (Gids). What we uncovered was a service driven more by ideology than by robust clinical reasoning. Many distressed children, often same-sex attracted and with autistic comorbidities, were put on a medical pathway to transition by some clinicians who had been captured by 'trans' ideology and, as a result, cast aside ordinary sound clinical judgment. A clinical trial risks repeating these ethical failures. These trials are governed by rigorous ethical and legal standards, designed to protect participants from harm. The foundation of these standards is the Declaration of Helsinki, alongside the Good Clinical Practice guidelines and the UK's Medicines for Human Use (Clinical Trials) Regulations. These frameworks exist to ensure that the benefits of any new medical intervention outweigh the risks. The Cass Review has made it clear that the evidence base for the safety and effectiveness of puberty blockers is extraordinarily weak, and that their risks are significant. Existing studies suggest serious concerns, including negative impacts on bone density, cognitive development, and future sexual function. Further, over 95 per cent of children started on a medical pathway will proceed to cross sex hormones and many to surgical intervention. Thus starting any child on PBs is freighted with that knowledge, and of course the ethical implications of that knowledge. To be clear, the prescription of puberty blockers in the context of a trial would, in effect, introduce a known risk of systemic physical harm to a physically healthy child. To put it mildly, this is a divergence from normal clinical trial practice. One of the core principles of medical research is that a clinical trial must seek to answer a question that cannot be resolved by other means. Yet in the case of puberty blockers, safer research avenues remain unexplored. We should be conducting robust long-term follow-up studies of those who have already undergone such treatment, qualitative research into the experiences of the growing numbers of detransitioners, and further animal studies to understand the biological impact of these drugs on adolescent brain development. Another major ethical concern is the question of informed consent. Children under 16 cannot legally provide informed consent for a Clinical Trial of an Investigational Medicinal Product, meaning that parental consent would be required. Yet, given the politicised environment surrounding gender identity, it is difficult to see how true informed consent can be obtained. For example, parents, subjected to trans activist narratives claiming that refusal to provide puberty blockers increases their child's risk of suicide, will not be in a position to make a free and uncoerced decision. The argument that puberty blockers prevent suicide is completely unsubstantiated. For example, a recent Finnish study found no significant difference in suicide rates among youth diagnosed with gender dysphoria when adjusted for mental health comorbidities. In the UK, Professor Louis Appleby, the leading authority on suicide prevention, has called for caution on the use of false assertions as regard risk of suicide in this group . Informed consent is meaningless when it is obtained under conditions of misinformation and fear. There are moments in medical history when the imperative to 'pause and reflect' must override the drive to push forward. Now is one such moment. Given the absence of an established safety profile, the lack of high-quality evidence supporting their efficacy, and the well-documented risks, any such trial would violate our ethical and regulatory frameworks. The medical community, politicians, and regulators need to draw a line under this scandalous piece of medical history. Instead of experimenting on confused children with medical interventions that do more harm than good, we should be dedicating our resources to understanding and addressing the root causes of gender distress, researching psychosocial treatments and following up on the 9,000 children who went through Gids. Let us not repeat mistakes of the past. Dr David Bell is a retired consultant psychiatrist and was a Governor of the Tavistock and Portman NHS Foundation Trust Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Telegraph
06-03-2025
- Health
- Telegraph
Why I'm sounding the alarm on the next puberty blockers scandal
Few issues in contemporary medicine have generated as much controversy as the use of puberty blockers in gender distressed children. The Government, responding to the findings of the Cass Review, has rightly banned the prescription of these drugs. Many other countries have, too. However the Government last week announced an £11 million clinical trial of these medicines to gather evidence of their effects. This raises a fundamental question: can a clinical trial of puberty blockers on children experiencing gender distress be done ethically? The answer, upon scrutiny, is a resounding 'no'. I have witnessed firsthand the grave dangers posed by the rush to medicalise childhood gender distress. As a former psychiatrist at the Tavistock and Portman NHS Trust, I was one of the whistleblowers who raised concerns about the practices at the now shuttered Gender Identity Development Service (Gids). What we uncovered was a service driven more by ideology than by robust clinical reasoning. Many distressed children, often same-sex attracted and with autistic comorbidities, were put on a medical pathway to transition by some clinicians who had been captured by 'trans' ideology and, as a result, cast aside ordinary sound clinical judgment. A clinical trial risks repeating these ethical failures. These trials are governed by rigorous ethical and legal standards, designed to protect participants from harm. The foundation of these standards is the Declaration of Helsinki, alongside the Good Clinical Practice guidelines and the UK's Medicines for Human Use (Clinical Trials) Regulations. These frameworks exist to ensure that the benefits of any new medical intervention outweigh the risks. The Cass Review has made it clear that the evidence base for the safety and effectiveness of puberty blockers is extraordinarily weak, and that their risks are significant. Existing studies suggest serious concerns, including negative impacts on bone density, cognitive development, and future sexual function. Further, over 95 per cent of children started on a medical pathway will proceed to cross sex hormones and many to surgical intervention. Thus starting any child on PBs is freighted with that knowledge, and of course the ethical implications of that knowledge. To be clear, the prescription of puberty blockers in the context of a trial would, in effect, introduce a known risk of systemic physical harm to a physically healthy child. To put it mildly, this is a divergence from normal clinical trial practice. One of the core principles of medical research is that a clinical trial must seek to answer a question that cannot be resolved by other means. Yet in the case of puberty blockers, safer research avenues remain unexplored. We should be conducting robust long-term follow-up studies of those who have already undergone such treatment, qualitative research into the experiences of the growing numbers of detransitioners, and further animal studies to understand the biological impact of these drugs on adolescent brain development. Another major ethical concern is the question of informed consent. Children under 16 cannot legally provide informed consent for a Clinical Trial of an Investigational Medicinal Product, meaning that parental consent would be required. Yet, given the politicised environment surrounding gender identity, it is difficult to see how true informed consent can be obtained. For example, parents, subjected to trans activist narratives claiming that refusal to provide puberty blockers increases their child's risk of suicide, will not be in a position to make a free and uncoerced decision. The argument that puberty blockers prevent suicide is completely unsubstantiated. For example, a recent Finnish study found no significant difference in suicide rates among youth diagnosed with gender dysphoria when adjusted for mental health comorbidities. In the UK, Professor Louis Appleby, the leading authority on suicide prevention, has called for caution on the use of false assertions as regard risk of suicide in this group . Informed consent is meaningless when it is obtained under conditions of misinformation and fear. There are moments in medical history when the imperative to 'pause and reflect' must override the drive to push forward. Now is one such moment. Given the absence of an established safety profile, the lack of high-quality evidence supporting their efficacy, and the well-documented risks, any such trial would violate our ethical and regulatory frameworks. The medical community, politicians, and regulators need to draw a line under this scandalous piece of medical history. Instead of experimenting on confused children with medical interventions that do more harm than good, we should be dedicating our resources to understanding and addressing the root causes of gender distress, researching psychosocial treatments and following up on the 9,000 children who went through Gids. Let us not repeat mistakes of the past. Dr David Bell is a retired consultant psychiatrist and was a Governor of the Tavistock and Portman NHS Foundation Trust
