Skip to main content

Role of Patient Advocacy Organizations in Medical Research and Development

BayBiotech.NET
In a clinical study, patient focus is central to the success and a patient centric study design and considerations can not be undermined. From start-up phase to maintenance until a study close-out, successful patient enrollment within timelines recruiting right population, safety and efficacy of the patients is a key sponsor and regulatory consideration. Any lapse in care, could cause millions for a sponsor in terms of credibility.

Those who have remained engaged in clinical study management have seen repeatedly, how important it is to keep patient advocacy groups engaged every step of the way to accommodate patient voice in the key study design. Patient Advocacy groups play a pivotal role representing the patient populations with certain conditions and support both a study sponsor contributing to the success of the study as well as could play a role in design optimizations to ensure patient voice is heard to meet the needs.

Found a great read on 'Understanding role of Patient Advocacy Organizations (even) in Funding Medical Research and Development' worth a read on the topic: https://lnkd.in/g_5bSNe9

Comments

Popular posts from this blog

Group C (Treatment IND) Drugs

BayBiotech.NET Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information. Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy. Making Group C drugs available to the critically ill patients not only provi...

Good Machine Learning Practices

BayBiotech.NET A joint effort by FDA,  United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have developed guiding principles to help promote utilization of medical devices that are safe and effective and utilize artiificial intelligence and machine learning. To find out more details check out the link here!

A New Clinical Trial Platform

BayBiotech.NET The Medpedia Project has established a platform ‘Medpedia Clinical Trials’ for patients, researchers and physicians to receive information about the thousands of clinical trials that are in process or about to begin worldwide. The information on various clinical trials is updated regularly from ClinicalTrials.gov and can be searched using different attributes with basic and advanced search functionalities. Medpedia Clinical Trials platform allows visitors to leave their comments, thoughts and views on a specific clinical trial page. Most importantly, a personalized feed can also be obtained if someone is interested in learning more about on-going or about to start clinical trials on a particular condition worldwide. Moreover, if you are reading a Medpedia article on a particular clinical condition, the information on the related clinical trials are fed automatically alongside the article page. To learn more about it visit http://www.medpedia.com/clinical-trials .