Featured Articles
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Considerations For Implementing Decentralized Clinical Trials
7/14/2020
Our teams have helped many sponsors navigate and implement decentralized solutions for their clinical trials and programs. This includes providing recommendations for the level of decentralization required (e.g. a fully virtual trial or a hybrid approach), as well as the development of strategic plans for remote and central monitoring, technology integration, IP management, and site and patient engagement. In this blog we discuss some considerations for successfully implementing decentralized solutions.
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Key Questions For The Effective Implementation Of eCOAs In Your Clinical Trial
6/2/2020
With the industry-wide push towards patient-centricity, electronic clinical outcome assessments (eCOAs) have become a more widely used strategy to streamline patient data collection, provide real-time access to data for review and monitoring, enhance patient engagement, and improve the integrity and accuracy of clinical studies. Here are a some answers to some commonly asked questions about eCOAs.
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The Sunsetting Of Rare Pediatric Disease Designation
6/2/2020
As with other incentive programs, FDA created the Rare Pediatric Disease (RPD) designation to encourage drug development in products with questionable financial viability. As things currently stand, FDA is sunsetting the program, and may not award priority review vouchers for any product unless the product has received RPD designation by September 30, 2020. How can a sponsor increase the chances of a favorable first round review with such a short window of time remaining?
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COVID-19 Treatment Development: Updates And Recent FDA Guidance
6/2/2020
The FDA continues to release additional information and update their website as the COVID-19 pandemic continues and both regulatory professionals and drug developers react to the potential for novel and repurposed products to treat COVID-19. This blog addresses recent changes to the Coronavirus Treatment Acceleration Program (CTAP) webpage as well as two new guidance documents for the COVID-19 treatment development.
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Maintaining Trial Integrity During COVID-19: Some Statistical Rules Of Thumb
5/6/2020
The COVID-19 pandemic is having a substantial impact on many ongoing clinical studies in all phases of product development. It is important to understand how to address amendments to key elements of efficacy data collection, assessment, and/or analysis.
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Drug Shortages During The COVID-19 Pandemic
5/6/2020
As the United States struggles to keep pace with the rapidly escalating COVID-19 pandemic, demand for healthcare services and supplies has revealed the precariousness of our healthcare system and supply chains in the face of such extreme challenges. Now another threat is emerging: shortages of essential drugs diverted from patients with their primary indications to treat patients infected with COVID-19.
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COVID-19 FDA Response: Site Management And Monitoring
5/6/2020
With a focus on participant safety and trial data quality and integrity, the FDA expectation is that sponsors will identify alternative approaches to on-site monitoring and document these in updates to the Clinical Monitoring Plan. This blog focuses on site management and monitoring changes during COVID-19.
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Development Of COVID-19 Therapies: FDA Pathways
5/6/2020
The FDA is currently using 3 programs to expedite development of COVID-19-related therapies, with the goal of making new treatments available to patients in the US as quickly as possible.
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COVID-19 FDA Response: Guidance On Protocol Amendments And Clinical Study Reports In Affected Ongoing Trials
5/6/2020
One of the impacts of the COVID-19 pandemic on the conduct of ongoing and planned clinical trials will be the need for protocol modifications to adjust for COVID-19 control measures and COVID-19 illness. This blog review a recent FDA Guidance that offers advice on managing protocol amendments and deviations and documenting changes to the trial.
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The Rise Of Electronic Clinical Outcome Assessments (eCOAs) In The Age Of Patient Centricity
4/17/2020
With the industry-wide push towards patient-centricity, electronic clinical outcome assessments (eCOAs) have become a more widely used strategy. No matter what strategy is used to implement an eCOA for your clinical study, there are several factors to consider before embarking on this path.