Investigator Grants
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This document discusses challenges in budgeting and negotiating investigator grants for global clinical trials in countries that are difficult to work with. It asks questions about central budgeting, outsourcing negotiations, gathering market intelligence, ensuring fair market value, dealing with differing regulatory timelines, and whether lower costs outweigh longer start-up times. The document is from a meeting in Philadelphia on January 10, 2012 discussing investigator grants in countries like Poland, Brazil, Russia, Argentina, China, India, and Japan.
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The document discusses two investigator-initiated studies funded by the National Heart, Lung, and Blood Institute (NHLBI). The first story describes a study that found reopening occluded arteries in patients who had a heart attack over 24 hours prior did not reduce risk of death or heart attack and was difficult to conduct due to physician bias in favor of the procedure and slow funding and recruitment. The second story discusses a study that found certain blood thinning drugs can prevent heart attacks and strokes, despite initial resistance from the medical community. The document advocates for continued government funding of investigator-initiated clinical trials to evaluate new treatments while managing conflicts of interest.
Phase IIIB & IV Studies Reflect the Evolution of Industry Needs & Market Real...
Phase IIIb & IV studies are evolving to better meet industry needs and market realities. Historically, these studies were commercially driven with low clinical and scientific value, but they are now focusing more on proactive safety to maintain benefits while reducing risks. Studies are also taking a more continuous development approach without clear boundaries between phases. This reflects the new global healthcare landscape where economics will play a central role and understanding of personalized medicine will increase. Future studies will need to generate and test hypotheses using large amounts of data to gain regulatory approval in this new environment of constrained resources.
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
The document discusses current challenges and future trends in clinical development from the perspective of a CRO. It notes that the global CRO market is large but fragmented, and outlines pressures on the pharmaceutical industry like high R&D costs, patent expirations, and regulatory demands. The text also examines trends towards more global, efficient trials using new technologies and less traditional geographies to address these challenges. It argues that collaboration between industry, regulators and CROs will be key to transforming clinical research processes to increase competitiveness and innovation.
Compliance and FMV - Seth Whitelaw
This document discusses the impact of corporate integrity agreements (CIAs) on clinical research and development operations. Specifically:
- Recent CIAs with AstraZeneca, Allergan, and Elan have imposed civil penalties and new compliance requirements that directly impact R&D activities, such as annual certification of clinical trial plans and audits.
- Future CIAs are expected to further influence R&D as these functions become more aligned with commercial operations. Areas like research fraud will also face increased scrutiny.
- Applying fair market value principles to clinical services makes good business sense and ensures compliance with various federal laws regarding transparency of financial relationships with healthcare professionals and institutions.
Compliance and FMV - Karen Lowney
The document discusses transparency requirements for reporting payments and transfers of value from applicable manufacturers to covered recipients such as physicians. It provides an overview of the federal "Sunshine" provisions and state transparency laws. Key points include who must report, what must be reported, reporting deadlines, and preemption of similar state laws.
Standard of Care - Donna Beardsworth
The document discusses standard of care (SOC) costs in oncology clinical trials. It notes that SOC considerations can help avoid double payments and ensure fair market value, and that incorporating SOC into trial design and budgets can result in significant cost savings of up to 34%. SOC works well for oncology trials because national guidelines for cancer treatment (NCCN guidelines) are widely accepted and followed in the US and influence third-party payer reimbursement and protocol design.
Emerging Regions - Alan Braverman
Poor patient enrollment is a major problem for clinical trials. 85% of trials are behind schedule, mainly due to slow enrollment, and only 6% finish on time. Enrollment delays are often due to poor feasibility assessments that overlook complex medical, clinical, and logistical factors, as well as mismanaged projects with unrealistic optimism and poor communication. Thorough feasibility studies conducted by specialized experts and maximum logistical support for sites can help trials better estimate enrollment needs and avoid delays.
Clinical Trial Costs in Emerging Geographies - Stephen Porter
1. VDDI Pharmaceuticals utilizes a virtual business model to outsource drug development functions like preclinical and clinical trials to reduce costs.
2. Xemilofiban is a drug product that has already undergone Phase II and III trials and has proven safety and efficacy advantages over existing products.
3. Conducting multi-center Phase II and III trials in China provides an opportunity to secure Chinese regulatory approval and save 2-4 years bringing the drug to market in China compared to other regions.
Effective Global Site Budgeting and Cost Management - Natalie Gosciminski
The document discusses Johnson & Johnson's current process for global site budgeting and cost management for clinical trials. The current process aims to provide consistency in approach, fair reimbursement, transparency, and appropriate support for negotiators. It involves developing a global reimbursement range based on fair market value assumptions, collecting county-level cost data, and negotiating site budgets while documenting any exceptions. Challenges include accounting for complex trial procedures, making efficient yet globally comparable budget comparisons, and balancing timelines.
Effective Global Site Budgeting and Cost Management - Forrest Swope
Effective global site budgeting and cost management requires balancing sponsor expectations with site needs while navigating internal constraints. The document discusses opportunities to improve budgeting at both the sponsor and site level. For sponsors, it recommends providing high-level cost estimates pre-award and more detailed estimates post-award, while leveraging experience and consistency across countries. For sites, it suggests negotiating at a high level to avoid haggling over line items, and ensuring agreed budgets can be tracked and paid.
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
The document discusses current challenges and future trends in clinical development from the perspective of a CRO. It notes that the global CRO market is large but fragmented, and outlines pressures on the pharmaceutical industry like high R&D costs, patent expirations, and regulatory demands. The text also examines trends towards more global, efficient trials using new technologies and less traditional geographies to address these challenges. It argues that collaboration between industry, regulators and CROs will be key to transforming clinical research methods.
Payment Practices, FMV, and Study Performance - Harold Glass
The document discusses several topics related to clinical drug trials including:
1) Payment levels do not improve study performance but may raise questions for regulators, and certain CROs and sites get paid more for reasons other than performance.
2) A study is examining factors associated with faster completion times in clinical trials such as the nature of the organization running the study, study design, and site selection.
3) There is no difference in completion times between studies run by sponsor companies or CROs, but larger companies tend to be slower and pay more except in Latin America.
R&D Productivity and Costs in Today's Health Care Arena - Pat Audet
The document discusses challenges facing the pharmaceutical industry including increased healthcare costs, decreased R&D productivity, and more difficulty achieving blockbuster drugs. It also outlines strategies the industry is taking to address these challenges such as focusing on specialty and biologic drugs, reducing R&D costs through outsourcing and adaptive clinical trial designs, and pursuing mergers and acquisitions.
Two Worlds - Larry Poli
Presentation delivered at "The State of Clinical Development Costs" conference in Philadelphia, PA January 11th and 12th, of 2011.
Effective Global Site Budgeting and Cost Management - Holly Squires
Presentation delivered at "The State of Clinical Development Costs" conference in Philadelphia, PA January 11th and 12th, of 2011.
Standard of Care - Ying Jiang
Presentation delivered at "The State of Clinical Development Costs" conference in Philadelphia, PA January 11th and 12th, of 2011.
More from TTC, llc (16)
Investigator-Initiated Studies: Two Stories from the NIH
Investigator-Initiated Studies: Two Stories from the NIH
Phase IIIB & IV Studies Reflect the Evolution of Industry Needs & Market Real...
Phase IIIB & IV Studies Reflect the Evolution of Industry Needs & Market Real...
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
Clinical Trial Costs in Emerging Geographies - Stephen Porter
Clinical Trial Costs in Emerging Geographies - Stephen Porter
Effective Global Site Budgeting and Cost Management - Natalie Gosciminski
Effective Global Site Budgeting and Cost Management - Natalie Gosciminski
Effective Global Site Budgeting and Cost Management - Forrest Swope
Effective Global Site Budgeting and Cost Management - Forrest Swope
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
Future Challenges of Clinical Development; a View from the CRO - Hani Zaki
Payment Practices, FMV, and Study Performance - Harold Glass
Payment Practices, FMV, and Study Performance - Harold Glass
R&D Productivity and Costs in Today's Health Care Arena - Pat Audet
R&D Productivity and Costs in Today's Health Care Arena - Pat Audet
Effective Global Site Budgeting and Cost Management - Holly Squires
Effective Global Site Budgeting and Cost Management - Holly Squires
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Investigator Grants
- 1. Working with Countries that are Difficult to Budget and Negotiate (Investigator Grants) Ying Jiang, TTC Dr. Alan Braverman, Independent Consultant Dr. Mitchell Katz, Purdue Dr. Peter Carberry, Astellas January 10, 2012 | Philadelphia, PA
- 2. Countries of Interest • Poland • Brazil • Russia • Argentina • China • India • Japan
- 3. Question #1 • Do you budget centrally for your global investigator budgets?
- 4. Question #2 • Do you negotiate all of the investigator agreements or do you outsource it to CROs?
- 5. Question #3 • How do you budget for emerging countries or countries that you have less experience with?
- 6. Question #4 • How do you gather market intelligence? Country specific requirements and etc. • Are you prepared for to pay for ancillary items such as concomitant meds or even things like IV tubing or IV bags which may be considered a ‘given’ here?
- 7. Question #5 • How do you ensure FMV and ensure your budgets stay competitive? • Do you have benchmarks?
- 8. Question #6 • Multiple parties agreements: how do you deal with the timing of CTA vs MOH/Ethics • For example: Poland needs a fully executed CTA to accompany the submission.
- 9. Question #7 • Timelines: do the lower per patient costs make up for the extended start-up times in some of these countries?
- 10. Thank You For Your Participation! TTC Corporate Headquarters TTC European 4548 Market Street Headquarters Suite M-20 136 Delaware Road Philadelphia, PA 19139 London, W9 2LL UK (215) 243-4103 (Tel) 44 (0)7792 145 831 (Tel) (215) 895-4001 (Fax) 44 (0)2086 584 033 (Fax) Visit our website @ www.ttc-llc.com