I recently participated in the Second Annual Executing Global Clinical Trials Conference, organized by Valerie Bowling of The Conference Forum. It was attended by about 150 participants and was co-located with another clinical conference on Disruptive Innovations in Clinical Trials. The conference covered many of the areas of importance to Contract Pharma readers. Topics included Commercial and Regulatory Strategies (by Mike Katz of Purdue Pharma) and CRO and Central Lab Management in Global Clinical trials (a roundtable with Gavin Choy of Supergen, Patrice Hugo of LabCorp and Carol Lewis-Cullinan of Amag Pharma).
The discussion covered areas such as guidelines for the selection process to qualify CROs and central labs. The CROs discussed have global presence, covering the U.S., Europe and Asia. The discussion also involved the risks with the CROs and central labs if a sponsor needs to conduct trials in various geographies. Different countries have unique logistics requirements, so a thorough knowledge of these requirements is essential prior to engaging into these global clinical trials.
The discussion also included the topic of how one goes about finding locals who really understand the culture, management and specific regulatory needs of the specific country needs, including local GCPs. Partnering with local niche CROs is a key to success at times, and it also comes from finding the right alliance with a global CRO, which already may have partnered with local counterparts to recruit and conduct clinical studies. One needs to engage with the local CRO through your local office or through a larger global CRO well in advance to plan clinical trial in a region where you may not have conducted a trial before.
The roundtable participants also stressed the importance of ‘managing the relationships,’ which included vendor/sponsor relationship, setting priorities, and effectively managing CRO/central lab functions, in concert with a logistics service provider such as Marken or a local provider. The sponsor has to have individuals who can track and do effective project management of the day-to-day trials effectively, without compromising quality. Some of the best practices they discussed involved adding direction and support for managing relationships. The key is always to do upfront planning to minimize change orders. If change orders must happen, there are smart ways of handling communications to effectively minimize disruptions in the process, thereby saving time and costs at the same time maintaining the quality output.
Melissa Easy of DrugDev.org summarized Global Site Identification and Start-Up Strategies, where she shared a new model for transforming protocol feasibility, site identification and start-up with a case study for T-cell lymphoma study in 14 countries, which had applicability to all therapeutic areas, using DrugDev.org, a social network of more than 63,000 independently rated clinical investigators in 93 countries. It is possible, she related, to rapidly capture protocol feedback and interest from highly targeted sites and then handle contracts electronically. Since sites are independently quality rated by more than 1,450 CRO and sponsor CRAs, they are usually able to share the risk based on site performance.
Ms. Easy shared the details of how one of client used this novel approach to determine country suitability, finalize its niche clinical study protocol and mobilize study sites, shaving almost 10 weeks off anticipated timelines and while using at least 320 fewer hours of staff time. The key takeaways from the talk were that sites have moved rapidly into the innovative way of doing clinical trials, taking advantage of outsourcing the tasks into the right partner companies, with CROs saving time and money as a result. It helps when one mobilizes sites before the protocol is finalized; this involves not just Key Opinion Leaders (KOLs), but the principal investigators (PIs) and trial coordinators that will recruit the bulk of the subjects or patients for the clinical trials. Through application of these means, coordination of global feasibility and study start up can be simplified and streamlined very efficiently.
Jason Scoggin from Grifols covered an important area of How To Manage Site Selection Process for a Global Study. According to Mr. Scoggin, Talecris Biotherapeutics shared its experience in how it manages a proactive approach to prepare for tracking and selecting a CRO in a new geography. It follows with knowing the elements of the country, the PI and the patients. He presented a checklist for the selection of a PI, which is the most critical step. The following steps include elements of a CRO’s metrics tracking, managing site selection and making an informed decision and a follow-through by efficiently communicating decisions to the team and the CRO.
A roundtable on How Companies are Managing Global Drug Development was covered by representatives from SCRC, KV Pharma, Amag Pharma and Bristol-Myers Squibb. The take-home messages included partnering with appropriate CROs that are local in the country and adapting some key strategies for managing partnerships. Paying particular attention to accommodating multiple regulatory bodies, as well as keeping focus on compliance, quality and specific oversight plans for managing CROs, PI and partner companies, helps significantly. It is critical to establish solid relationships with local KOLs.
The conference was quite well organized by Ms. Bowling and provided ample networking opportunities for the participants of both events!
Makarand (Mak) Jawadekar most recently served as Director, Portfolio Management and Performance at Pfizer Global R&D, until February 2010, when he opted for an early retirement after 28 years at Pfizer Inc. He currently serves on several companies’ advisory boards and also consults with bio/pharmaceutical companies for global outreach in emerging market regions. He can be reached at email@example.com.