Maximizing Efficiency in Scientific Review and Regulatory Obligations

Marc Ernstoff, MD, of the National Cancer Institute in Bethesda, Maryland, chaired a panel that focused on mechanisms for improving scientific review and meeting regulatory requirements of clinical trials. 

In his summary of the panel’s discussion, Dr Ernstoff noted that a lack of uniformity in contract and budgeting processes as well as in protocol documents contributes to inefficiency. When protocol documents lack clarity about required procedures or eligibility parameters, amendments and addenda add to the regulatory burden for staff, potentially even threatening continued trial participation.


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The panelists advocated for harmonizing regulatory requirements across international agencies. Institutional review boards have improved regulatory processes for all parties, without sacrificing patient safety. Centralized scientific review boards for multisite studies should be developed and pilot-tested, the panelists recommended. 

Increasing the Speed of Study Activation and Conduct

Panel chair David Hong, MD, of the University of Texas MD Anderson Cancer Center in Houston, noted that the mean time from the submission of an investigational new drug application to the drug’s approval is 7.6 years for antineoplastic agents.3 

Dr Hong recounted a time in 2017 when MD Anderson department chairs were asked to identify issues that impact their ability to fulfill the institution’s mission. Delays in time to clinical trial activation were among the most important factors mentioned.

Dr Hong noted that study activation has multiple sequential steps without feedback loops to assess the value of each component of the process (eg, legal review, contract approval, and budgeting). 

The steps lack consistency from trial to trial and across sponsors and sites. For example, treatment arm builds in a site’s electronic health record drain a considerable amount of staff time and, in most instances, cannot be applied to more than a single study. 

Dr Emens noted that platform trials can accelerate the protocol activation process. Platform trials substitute arms and treatments sequentially, without requiring redevelopment, renegotiation, and re-approval of the entire trial when new agents become available for testing.4 

Changing the Business Model

Michael Gordon, MD, of HonorHealth in Scottsdale, Arizona, and Krystyna Kowalczyk, chief executive officer and president of OncoBay Clinical in Tampa, Florida, co-chaired the panel that was tasked with discussing the clinical trial business model. 

In summary remarks about the panel’s deliberations, Dr Gordon characterized the current research business model as one that incentivizes “pay for tasks” and has led to steady expansion of the number of tasks required of staff members, sponsors, and contract research organizations. 

Eliminating or changing the reimbursement structure and focusing on key performance metrics (eg, accruing eligible patients, satisfying regulatory or data submission target dates) could allow trials to be completed more expeditiously and at a lower cost. 

The panel supported exploring innovative partnerships to increase enrollment, including partnerships to involve historically underrepresented patient populations. 

The panel also noted that, in an era in which research office staff may work from home, the site approach should be reconsidered. Certain functions that historically have been performed in-house may be suitable for outsourcing.

Disclosures: Some of the panelists declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the summit’s program book for a full list of disclosures.

References

1. Society for Immunotherapy of Cancer. Crisis in Clinical Research Virtual Summit – Panelists, Agenda and Recording. August 17, 2022. Accessed November 2, 2022. https://www.sitcancer.org/advocacy/crisis-in-clinical-research/crisis-in-clinical-research-schedule 

2. Upadhaya S, Hubbard-Lucey VM, Yu JX. Immuno-oncology drug development forges on despite COVID-19. Nat Rev Drug Discov. 2020;19(11):751-752. doi:10.1038/d41573-020-00166-1

3. Kaitin KI, DiMasi JA. Pharmaceutical innovation in the 21st century: New drug approvals in the first decade, 2000-2009. Clin Pharmacol Ther. 2011;89(2):183-188. doi:10.1038/clpt.2010.286

4. Park JJH, Harari O, Dron L, et al. An overview of platform trials with a checklist for clinical readers. J Clin Epidemiol. 2020;125:1-8. doi:10.1016/j.jclinepi.2020.04.025