clinicalresearch

In a congruency review, the primary objective is to ensure alignment across various elements in clinical research. The initial crucial step involves accurately analyzing Medicare coverage, determining designations based on National and Local Coverage Determinations. This forms the foundation for what is billed to the study sponsor and insurance. Any discrepancies at this stage can lead to downstream errors.

Following the coverage analysis, it becomes imperative to align the calendar with the protocol's schedule of events and the designated elements from the coverage analysis. Once the calendar is established, the focus shifts to the budget negotiation phase. Multiple touchpoints during budget negotiations necessitate periodic checks to confirm alignment with the calendar and coverage analysis designations.

On the contractual side, congruency revolves around matching the contract and budget provisions. This involves verifying that payment terms and the final budget in the contract align with the negotiated terms. Another critical aspect is ensuring congruency between the informed consent and the contract, specifically focusing on subject injury language. Standardized language for subject injury in both the informed consent and contract streamlines the congruency process. Deviations from these standards trigger communication between those handling the informed consent and contract to ensure alignment. This meticulous congruency review safeguards against discrepancies and ensures a seamless process in clinical research.

We delve into the growing allure of clinical research sites and organizations for private equity firms. Backed by BPOC, these investments signify more than just single business deals; they are a testament to the increasing interest in fueling healthcare innovation and services.

As this trend gains momentum, thorough due diligence becomes crucial in navigating the complexities of these acquisitions. The Kulkarni Law Firm, specializing in Life Sciences law, plays a pivotal role in providing comprehensive support for regulatory compliance, contract reviews, and risk assessments. Daron emphasizes that these investments go beyond financial gains, contributing to the redefinition of the healthcare investment landscape.

The Kulkarni Law Firm keeps a watchful eye on the latest updates from the Department of Justice (DOJ), Office of Inspector General (OIG), and the Food and Drug Administration (FDA), ensuring that clients are well-informed and compliant. 

Darshan Kulkarni emphasizes the importance of selecting the right company for clinical trial recruitment. Key considerations include the company's experience and expertise in a specific disease state or area, its reach (national, international, or local), and the associated costs. He warns against the trend of traditional marketing companies entering the clinical trial recruitment space, advising careful assessment of their experience and disease state knowledge. He also suggests that while this trend is emerging, its ultimate impact remains uncertain. Additionally, he concludes by encouraging those in need of assistance with training, policy development, or gap analyses to contact Darshan Kulkarni at darshan@kulkarnilawfirm.com

In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board (IRB) goals with the essence of a clinical study becomes pivotal. If the trial's outcome is already known, it may be labeled a seeding trial, raising ethical and FDA-related red flags. Conversely, administering a drug with uncertain effectiveness to a hopeful patient brings its own set of ethical and legal challenges. 
This evolving landscape demands careful consideration and resolution of ethical and legal issues associated with integrating clinical research and care. 

Stay tuned as discussions on this innovative approach continue to unfold.

Guest Istvan Fekete discusses what large academic medical institutions are responsible for that sponsors and other commercial entities are generally not. Key considerations include the complexities of handling publication rights, the impact of tax-exempt municipal bonds on project restrictions, ensuring equal patient treatment, the reality of universities generating revenue from intellectual property, the distinct goals of principal investigators versus institutions, and the necessity of a comprehensive congruence review among documents related to clinical trial agreements.
 
Points discussed:

1. What are the 6 big areas that large academic medical institutions tend to think about that sponsors or smaller hospitals/private institutions may not be thinking about in the context of clinical trial negotiations? - 2:29- 4:55
2. Are tax-exempt municipal bonds a factor in clinical trial negotiations? 4:58- 12:03
3. What is the impact of the Bayh-Dole Act on publication rights? 12: 04- 13:40
4. Why do we not discuss confidentiality as much as we talk about publication rights?- 13:41- 21:26
5.  Should sponsors have the right to be present during an FDA audit in a large medical center?- 21:27- 24:19
6. Should sponsors have a right to review and change a proposed audit in the case of a larger academic medical center? Check out our latest podcast episode to find out. 24:20- 26:20
7. 6 different types of clinical trial transparency. - 26:21- 29:30 

Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship.

On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data.
 
We highlight the significance of pharmacists recognizing red flags indicating potential fraud, including patients unknowingly or involuntarily enrolled in clinical trials.
 
Beyond the broader impact on public trust, pharmacists could face specific repercussions, such as disciplinary actions from the State Board of Pharmacy. Moreover, clinic owners could be barred from participating in research activities.
 
Implementing robust internal controls and collaborating with law enforcement to identify and report suspected fraud are essential steps for pharmacists and clinic owners to safeguard themselves from legal ramifications.

 Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clinical trials. Specifically, Tatsene failed to test on the appropriate number of subjects, thus compromising the integrity and reliability of the trial data. How to Avoid this Fate: To sidestep such consequences, individuals and organizations must strictly adhere to FDA guidelines, which include rigorous clinical trial protocols like proper sample sizes for testing. Failing to do so could result in severe penalties, including debarment. Impact: This action sets a precedent that has significant implications for clinical researchers and Contract Research Organizations (CROs). Not only does it tarnish reputations but it also raises questions about data integrity, potentially delaying drug approvals and harming patients in the long run. 

For episode 7, we chat with Alex Zhavoronkov, Founder & CEO at Insilico Medicine.

Stay tuned and find out which partnerships are crucial for very early stages in learning and gaining experience in drug discovery.

First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder.

Episodes launch weekly on Tuesdays.

To view the full episode transcript, click here.

Interested in being featured as a guest on First In Human? Please reach out to catie@vial.com.

🎧 Stay in the Loop!

For the latest news and updates, visit our website: https://vial.com

Follow us on social media for real-time insights:

Twitter: https://twitter.com/VialTrials

LinkedIn: https://www.linkedin.com/company/vialtrials

For episode 5, we chat with Matt Schwartz, CEO & Co-Founder of Virgo.
Listen in to  find out Matt's thoughts on Decentralized Clinical Trials and why they aren't really applied well in the realm of IBD trials.

First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder.

Episodes launch weekly on Tuesdays.

To view the full episode transcript, click here.

Interested in being featured as a guest on First In Human? Please reach out to catie@vial.com.

🎧 Stay in the Loop!

For the latest news and updates, visit our website: https://vial.com

Follow us on social media for real-time insights:

Twitter: https://twitter.com/VialTrials

LinkedIn: https://www.linkedin.com/company/vialtrials

How can researchers conduct an asthma study, which African Americans are 40% more likely to suffer than non-Hispanic whites, with only a handful of African Americans in the group? Andrea Durham wondered the same thing, starting Durham Research Collaborative to make clinical research more inclusive, assessible and seamless. In this episode, DBJ Managing Editor Rob Schneider profiles Durham, one of our 40 Under 40 Honorees.