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Current Status of Decentralized Clinical Trials

D2E Catalyst Past pandemic, concept of decentralized clinical trials (DCT) has drawn attention but yet not replaced traditional site-based trials. Currently, they have become a durable part of mainstream clinical operations, mostly in hybrid form. Regulators now clearly recognize decentralized elements such as telehealth visits, home-health visits, local labs, and remote data collection, and the FDA has formal guidance in place for how to run trials using those methods.   As of its current status, concept of DCT has won, but full decentralization has not. Sponsors are using decentralized components where they reduce patient burden or improve recruitment and retention, while keeping site-based procedures for activities that are harder to decentralize, such as complex exams, investigational product handling, or high-risk monitoring.  The evolving field is still constrained by several unresolved problems and recurring issues such as data quality and validation, operational c...
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Vendor Management Success in Clinical Study Set-up

BayBiotech.NET
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FDA's Guidance Document intended for Global Harmonization of framework for presenting Quality data

BayBiotech.NET, D2E Strategic Advisors  The FDA has opened a new guidance document, M4Q(R2), The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality, intended to establish a globally harmonized framework for presenting quality data in registration applications. Link: https://lnkd.in/gr9A8W8a Jaya Pandey, Ph.D., SCPM Founder, D2E Strategic Advisors (Clinical Operations Excellence)
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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 ...
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Participant safety monitoring in Decentralized Clinical Trials

BayBiotech.NET Decentralized clinical trials should account for adequate processes for reporting medication errors and safety events...A well-organized plan must include training of participating HCPs on following study protocol processes for the reporting of adverse events. Not only should HCPs be made aware of the contact details of the study personnel, but participants should also be informed so they can reach out for medical assistance. A lot of these responsibilities to prepare the logistical details fall on the study sponsor; however, study Principal Investigators also remain responsible for working with local HCPs to monitor the clinical safety of the participants... Useful link: https://www.fda.gov/media/189263/download?attachment
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Investigational Product consideration element in a Decentralized Clinical Trial:

BayBiotech.NET I nvestigational Product consideration element in a Decentralized Clinical Trial: In any traditional clinical study, administration of the investigational product (IP) to the study participants should be performed under the supervision of the investigator or the delegate medical representative. If a clinical study is considering a decentralized clinical trial model, there are certain factors to be considered for IP administration. For IP that has a high-risk safety profile, especially in the immediate post administration period, may need on-site dose administration under close supervision of the protocol trained principal investigator. However, for IP with a defined safety and stability profile and with well-understood low risk characterization may be administered at local health care facilities, mobile research facilities or at study participant's home. Regardless, for an investigational product, a well-established chain of custody and well documented accountabilit...
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