
What are the Concerns for Foreign Clinical Trials?
Read the Report on CHALLENGES TO FDA’S ABILITY TO MONITOR AND INSPECT FOREIGN CLINICAL TRIALS and Read the New York Times Article.
MRCT Project
The second report I learned about when I attended a session at the recent meeting of the Drug Information Association (DIA). The session discussed the challenges of international clinical research, particularly in developing countries. In a report of the Multi-Region Clinical Trials (MRCT) project, problems were discussed and practical recommendations suggested for improving the quality of clinical trials in resource-deprived countries.
I was impressed with the panelists who presented to DIA on the MRCT project. The focus was on how clinical trials could be conducted in developing countries with resource challenges. How could the rights, safety, and welfare of research participants be protected? The session was chaired by Mildred Solomon, EdD, Associate Clinical Professor of Medical Ethics at the Harvard Medical School. She discussed the formation of the MRCT project and the report that resulted. Other panelists included Allan Johansen, DVM, Susan D’Amico, and Janet Wittes, PhD. According to the report the MRCT project was:
“Initiated by Pfizer, the Multi-Regional Clinical Trial (“MRCT”) Project began with a Summit Meeting in July 2009 to identify ways to enhance the planning and conduct of multi-regional trials and the integrity of these trials. The Project has involved experts from large and small companies, clinical research organizations (CROs), non-industry sponsors of research (such as participants from the National Institutes of Health), non-industry researchers and bioethicists, and others. The discussions have focused on opportunities to enhance research ethics, ensure respect for study subjects, strengthen fairness and equity in clinical trials, protect subject safety, and identify other opportunities to improve MRCTs involving the developing world.”
The project formed work groups to cover five areas:
1. Efficiency and quality of ethical review
2. Data & safety monitoring
3. Site selection and investigator
professionalism
4. Monitor performance
5. Transparent contract amendments

Five Workgroups Formed the MRCT Project
The report discusses the problems in each area and offers some solutions. For example, work group one proposed to “Include an ethics section accompanying each/certain protocols (to help ethics committee review the proposal, as needed).” Work group 4, which focused on monitor performance, proposed to: “Establish a comprehensive set of recognized and expanded core competencies for monitors.”
The report concluded by noting:
“This Report has focused on outcomes that sponsors and CROs have the ability to impact and, thereby, improve research ethics and data integrity in their own operations or through collaboration. Since there is already broad acceptance of foundational ethical principles, the next important step is to ensure operational alignment with those principles.
Predominantly, the MRCT Work Group proposals focus on achieving that alignment through greater professional competence of the many players who must contribute to the global research enterprise. Professionalism is essential to the ethical conduct of clinical research. Just as scientifically unsound research is unethical, so too is research conducted in a manner that cannot ensure the integrity of the science, the quality of the data, and respect for and safety of research participants. Assuring all individuals engaged in research are properly qualified through education and experience is a theme throughout this Report.”
The report also noted that developed countries and the pharmaceutical industry need to assist with resources to achieve this goal. This is certainly an important point. However, the devil is always with the details. Finding a way to finance improvements may prove difficult.
My own viewpoint is that we should stop referring to “foreign” clinical trials. Clinical research is globalized and we need a strong international component. Not all of the answers are in the United States and we would do well to listen to those from outside our borders, particularly those from the developing world. To me, referring to clinical trials from outside the U.S. as “foreign” infers that they are inferior to trials conducted in the U.S. I don’t think that is always the case. Why don’t we call them “international” or even “multi-regional” trials instead? If we view international research as something that is a shared responsibility then perhaps there would be less concern over “foreign” clinical trials.
GxP Training Part 2: Regulatory Compliance for FDA Regulated Industry
June 20, 2010What is the Best Method of SOP Training for GxPs?
Guest Commentary
Part 2:
Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program
June 9, 2010
Nancie E. Celini, GxP Learning Program Lead
In the previous article I discussed the use of the acronym “GxP” as well as regulations, a changing industry landscape and some suggestions for becoming a learning organization. In this article we will look at learning and why having a strategy, leadership and a comprehensive program is so important in our work and to our future success.
Sponsor organizations have traditionally relied upon a “Read and Understood” approach for instructing its workforce on procedural documents (e.g. Policies, SOPs, working instructions). While this may be a reasonable approach for certain procedures, this method can be unreliable. Reading procedures alone, without additional context and details may leave an organization vulnerable. Employees need to fully understand their job role and responsibilities in context as regards the regulations that keep the organization compliant.
FDA Requirements for Training and Experience
FDA has (and will) cite companies for deficiencies in their training programs. U.S. regulations can be broad and subject to loose and often incorrect interpretation. The regulations stipulate that personnel must have “training and education and/or experience” to enable them to fulfill their role. In today’s dynamic e-clinical environment where many functions are virtual and rely upon third parties, this phrase takes on new meaning.
GxP learning programs must be robust and comprehensive and should include the following components:
• Introductory Level (GCPs, GMPs and/or GLPs) for new employees
• Policy and provision for outsourced / consulting personnel who perform regulated activities for you
• Yearly refresher GxP courses that don’t just recite regulations but focus on changes to existing regulations as well as emerging guidance and trends of health authorities / regulators (as well as the political context / global issues / economics and externalities)
• A blend of leader-led and on-line courses (e.g. a “hybrid” model)
• Qualified learning professionals / instructors who lead, manage, deliver and sustain the program
• Complete training records; current organization charts; descriptions of roles and responsible parties in the chain of authority; current job descriptions and records of training courses completed linked to roles / responsibilities
• Curriculum Vitae (updated as changes occur)
• Organizational Training Policy and SOP that govern the overall GxP program
A GxP learning program should be role-specific regarding organizational job descriptions and collaboration across functions (clinical, regulatory, human resources, training, etc.). This is critical and likely to be where gaps in procedures and training can occur. Personnel need to understand how procedures relate to each other. Often there is no reference from one process to another that creates these gaps that can lead to deficiencies and ultimately, citations.
Are There Advantages to a Learning Management System?
But don’t forget the classroom. Leader-led sessions enhance the read and understood approach especially for procedures and allow professionals to work collaboratively. And the right LMS can manage your leader-led program as well as your on-line content.
As an educator I want to close by giving you some retrospective history about “training” in our industry. At one time training departments were plentiful in this industry with knowledgeable trainers who were committed to their trade. Due to previous economic downturns, the industry started to downsize and cut many training programs. Sadly, it has been hard to come back from these difficult times and we find ourselves in the midst of climbing out of yet another tough economic trough. Considering patent expirations and tough business and scientific challenges we all face, it is often difficult to justify a program that I have described. But the business of training needs to change in our industry as I’ve seen too many deficient programs that have been relegated to an unimportant level in many organizations. Here is something to reflect on from John Dewey;
“Any genuine teaching will result, if successful, in someone’s knowing how to bring about a better condition of things than existed earlier.”
GxP Training for Regulatory Compliance
If you are interested in this topic or further discussion about transforming from training to learning in this changing industry, please feel free to reach me through Carl’s blog. I want to say a great big thank you to Carl for providing this space for thoughtful discussion and insight. I hope you have enjoyed these thoughts on GxP education.
Good luck and good learning!
Read Part One of Nancie’s training article
The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.
GxP Perspectives LinkedIn Group
Share this:
Like this: