CBI’s Fifth Annual Investigator Initiated Sponsored Research Conference, held in Philadelphia February 13th and 14th, brought together representatives from drug manufacturers and clinical research organizations to openly discuss the difficulties, as well as the opportunities, in advancing and conducting clinical trial research.
The relationship between drug manufacturers and contract research organizations (CROs) continues to gain complexity as research agreements expand in scope to include additional organizations, geographies and assumptions affecting elements of policy and procedure.
Some of the key discussion points included:
- International collaborative research
- Clinical trial networks
- Defining FMV, agreement policies, and clinical procedures
Particular attention was also paid to opportunities to partner with international and/or collaborative networks which allow for greater sharing of resources and scientific intelligence. However, these engagements place greater stress on the contractual and procedural agreements in place between the manufacturers and the CROs, as well as the assumptions made around Fair Market Value (FMV), Anti-Bribery/Anti-Corruption (ABAC) statutes, data ownership/reporting and risk management.
Expanding clinical trial engagements to international collaborations opens the door to many advantages, including access to patient populations, disease states, more diversified clinical costs and varying trial start-up times. The decision to conduct a trial in a specific country may incorporate these elements with varying levels of weight to select the most appropriate countries for the trial. Although the decision may ultimately lead to an effective trial, managing the operations between clinical sites, the CRO and the relationship back to the drug manufacturer becomes exceptionally complex and assumptive.
Kjersten Teeter, Associate Director Global Medical Affairs, of Genezyme, and Karen Bartels, Director of Oncology Early Development, of AstraZeneca, led a workshop titled “Effectively Manage Global IISR Programs for International Innovation”. Throughout this interactive workshop, representatives of drug manufacturers and clinical research organizations discussed and recognized key areas of concern when engaging international clinical research.
Among the concerns discussed, the most prevalent revolved around the contractual and procedural agreements as the scope expands to incorporate multiple countries, and how to address the requirements per country. In addition, varying levels of regulatory requirements must be recognized to manage the risk in deciding Fair Market Value, ABAC statutes, data ownership, and management of the investigational drug supply.
Clinical trial networks
Similarly, clinical trial networks, making use of multiple research sites and resources, incur a degree of stress on the contractual and procedural agreements. Dana Sparks and Nathan Eriksen of SWOG, a member of the National Clinical Trials Network (NCTN), which focuses on cancer research, and Meg Mooney of the National Cancer Institute, held a session entitled, “Establish Collaborative Partnerships with Cooperative Groups”, where they discussed the relationship between clinical trial networks and drug manufacturers. The National Clinical Trails Network is comprised of five US Network groups and one Canadian Network group. Membership to a single group is approved based on criteria specific to that group, for which each group has a focus (e.g. Oncology, Pediatrics, etc.). Although the groups vary in therapeutic exclusivity, the network’s structure allows cross-group trial participation based on qualifications of the investigators to be involved. This opens opportunities for expanded research, additional patient populations and clinical sites. As the scope expands, the manufacturer must maintain an awareness of the additional resources and sites being incorporated into the study.
Both international research collaborations and clinical trial network engagements expand research beyond the local level, and incorporate varying layers of regulatory requirements of which the drug manufacturer and CRO needs to be made aware to manage risk. Polaris Management Partners’ Mario Prohasky and Jennifer Bang expanded on the risk management strategies of international and network engagements in their session titled “Examine the Need for HCO Engagement Risk Management in Evaluating IIS Grants”. The Polaris representatives outlined the risk mitigation plan into four key steps:
- Background and due diligence checks on research topic and investigators
- Institutional site credibility checks
- FMV assessment of budget proposals
- Standard Operations Procedures (SOPs) and policies to address responsibilities and provide proper training
Each of these steps work to effectively manage the operation of the clinical engagement as the scope and scale is expanded to incorporate additional geographies, countries, clinical groups, facilities, and resources.
Throughout the international and clinical network discussions, representatives from the manufacturers and CROs presented varying strategies for addressing some of the topics Polaris had recognized in the key steps to managing risk. Addressing FMV, discussion focused around the lack of awareness at the local levels, and benchmarking difficulties as well as standardization of budget templates. By a show of hands, the clear majority of attendees use some form of budget template, but have difficulty recognizing budget requirements and coming to an agreement between organizations due to expense coding or template format.
The Polaris team also reviewed a practical benchmarking approach to FMV which is based on assessing the reasonableness of individual cost items or larger cost groupings, and can be implemented relatively quickly and efficiently. With respect to broader risk management questions such as data reporting and ABAC, the Polaris team discussed ways in which risk mitigation can occur without hindering the ability of manufacturers and clinical research organizations to collaborate effectively.
In summary, managing relationships between drug manufacturers and the clinical research organizations has become exceptionally complicated as additional resources, researchers, and sites are incorporated into engagements. Without industry-wide defined processes, the need for expert evaluations and guidance has become increasingly more valuable, as the engagements now require exceptional scrutiny and awareness of the IISR environment.