Clinical trials researchers (including
clinicians/clinical pharmacologists,
trial management staff,
statisticians,
trial methodologists) |
Medical Research Council-National Institute for Health and Care Research Trial Methodology Research Partnership (MRC-NIHR) (UK) UK Clinical Research Collaboration Network of Registered clinical trial Units Targeted conferences or organisations such as the Society for Clinical Trials, International Clinical Trials Methodology Conference, International Society for Clinical Biostatistics, Statisticians in the Pharmaceutical Industry, European Federation of Statisticians in the Pharmaceutical Industry, Drug Information Association Clinical Conferences such as the National Cancer Research Institute (NCRI) annual conference (NCRI), the European Society for Medical Oncology congress, American Society for Clinical Oncology, the Experimental Cancer Medicine Centres events, European Centre for Rare Diseases and orphan products Sponsors from industry (via organisations such as Pharmaceutical Research and Manufacturers of America in the US, European Federation of Pharmaceutical Industries and Associations in Europe) or the Association of British Pharmaceutical Industry Publications: Corresponding authors of papers selected for the Methodological review as well as papers identified but not sampled. If necessary, further searches without data limitation may be performed Executive Committee members’ professional contacts Targeted professional social network groups
|
| Regulators |
US Food and Drug Administration European Medicines Agency UK Medicines and Healthcare products Regulatory Agency Japan Pharmaceuticals and Medical Devices Agency China National Medical Product Association Centre for Drug Evaluation. Australia Therapeutic Group Administration Drugs Controller General of India Health Products and Food Branch, Health Canada Ministry of Food and Drug Safety, South Korea Executive Committee members' professional contacts
|
| Ethics committee/ethicscommittee members |
UK Health Research Authority (targeting Research Ethics Committees specialised in reviewing early phase trials) European Network of ethics Committees US Institutional Review Boards Australia Health Research Ethics Committees registered through the National Human Medical Research Council. India Institutional Ethics Committees Health Canada and Public Health Agency of Canada Research Ethics Board South Korea Institutes Review Board Executive Committee members’ professional contacts
|
| Journal editors, associate editors and conference abstracts review committee members |
Leading medical research journals in publishing clinical trials, and targeted journals will be informed by journals where many phase I trials have been published (identified through Methodological review) International Committee of Medical Journal Editors Abstract review Committee members from leading conferences presenting phase one results (see above) Executive Committee members' professional contacts
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| Funders/funding committee members |
Funding panels such as MRC, NIHR, Cancer Research UK, Blood Cancer UK, Wellcome Trust, Bill & Melinda Gates Foundation, Great Ormond Street Hospital and other selected charities funding phase one work as applicable USA National Institutes of Health Pharmaceutical companies Executive Committee members’ professional contacts
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| Patients and public |
Patient and Public engagement platforms European Patients’ forum https://www.eu-patient.eu/ International disease-specific advocacy groups Patient representatives on phase one trials management groups (through Clinical Trials Units portfolios) Executive Committee members’ professional contacts
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