Society for Clinical Data Management (SCDM)’s Post

Our study titled, “Best Practices in the Oversight and Management of Investigator Initiated Trials,” shows that scientific value, strategic fit with company objectives, and clinical feasibility are critically important when evaluating an IIT proposal. Grab your free summary here: https://lnkd.in/dpSYt5ES #InvestigatorInitiatedTrial #ClinicalTrial #ClinicalResearch #MedicalTrial #BestPractices

Too late tonight for East Asia, but not really if your are in India onwards to the West...Increased protocol complexity. Technology overload. Explosion of data volume. These recent events have strained investigative sites on unprecedented levels. Parexel recently partnered with @The Tufts Center for the Study of Drug Development to conduct in-depth interviews with investigative sites on the current challenges they are facing, potential solutions and success measures for productive sponsor-CRO-site relationships. In this webinar, clinical development and site experts will discuss the study findings, the greatest opportunities for improvement and the steps our industry needs can take to move the needle. Don't miss it: https://lnkd.in/g966JsUw

A great table with simple and clear instructions on the ICF obtaining process. (Gupta UC. Informed consent in clinical research: Revisiting few concepts and areas. Perspect Clin Res. 2013 Jan;4(1):26-32. doi: 10.4103/2229-3485.106373. PMID: 23533976; PMCID: PMC3601699.)

A feature in Nature Medicine examines systematic reviews and meta-analyses, which can be used to amplify falsified or poor-quality clinical trial data, and how, in this era of contested evidence, new approaches are needed. 🔒 #Medicine #Research #Misinformation

Acta Scientific Clinical Case Reports (ASCR): https://lnkd.in/gGsS8_SF Submission link : https://lnkd.in/gkCUbBfH #articles #publication #newissue #researchers #casereports #ascr #clinical #medical #cardiology #pulmonology #urlogy #orthopedics

How does the medicine you take know which part of your body needs to be treated?💊 Olainfarm expert Vadims Kisis, Head of Medicine and Clinical Research Department, answers frequently asked questions about medicines. Listen to the video! 🎥

Statistical points in clinical trials: - P-values - Effect size - Confidence interval - Sample size - Clinical relevance   #clinicalresearch #clinicaltrials #medicalwriting Thanks Jenni Pickett for a great roundtable discussion at AMWA conference.

Including qualitative research in clinical trial design is an innovative approach to understanding patients’ perspective and incorporate the patient’s voice in all stages of #drugdevelopment and evaluation. Read the article for insights. https://ow.ly/iESk50PbErc #Clinicaltrials

In-trial interviews can generate information to help: - interpreting meaningful changes during regulatory and reimbursement processes - health authorities understanding benefits and risks of a drug In this paper written in collaboration with ICON plc and Merck Healthcare, our team at Mapi Research Trust (Rocco Adiutori, PhD, Céline Desvignes-Gleizes) performed a literature review on the acquisition of qualitative data during clinical trials and how health authorities consider this information during the marketing authorization and reimbursement processes. This literature review allowed to identify common methodologies and designs, as well as different research questions that helped explore the patients' perspectives in the drug development process. Moreover, we examined the case of four drugs to describe how regulators and health authorities considered the inclusion of qualitative data within the product labels. For more insights, read the full paper here: https://lnkd.in/e7bHZcBw #patientinterviews #patientvoice #drugdevelopment #clinicaltrials

The ACTA 2024 Clinical Trials and Registries Symposium invites authors to submit abstracts for presentations within the 2024 theme: Effective, together. acta2024.com.au