Guest Commentary: Quality in Clinical Research --- An Indian Perspective
Thursday, May 28, 2009 09:27 AM
At a recent ACRP chapter meeting in
Clinical Trials in
Several audits and inspections by health authorities have reaffirmed the fact that good quality is possible while performing studies in
A panel discussion was organized to debate issues related to quality while conducting studies in
The following is a detailed report of the panel discussion held as a part of the 3rd meeting of
Challenges in Improving Quality in Clinical Research: An Indian Perspective
Raman Shetty (RS); Dr. Sacchidananda (SC); Suresh Ramu (SR); Anil Shinde (AS); Larisa Singh (LR); Mitesh Patel (MP)
RS: Is there a problem about the quality of data being generated by
SC: The key challenge is in getting the right people. In my opinion, it helps if the study coordinator is a medically qualified person as he is aware of what is being documented. This greatly reduces errors in the source data. Another challenge lies in making the site coordinators document events accurately. While mistakes do happen, it is all right as long as there is a documented reason for any discrepancy observed.
MP: There is no problem in the quality of data generated from clinical trials conducted in
LS: The challenge ahead lies in understanding the process of clinical research, interpretation of guidelines, training and experience of the staff members. Clinical research professionals should have a complete picture of the process and understand the criticality of their role. They need to be intelligent monitors who can observe patterns and trends rather than blindly following procedures. Monitors need to be strong and capable of taking clear and objective decisions and also be detectives of high calibre.
AS: There are some lacunae in methods of practices in
SR: The problem of delivering consistent high quality in clinical research is not only in developing countries like
RS: The boom in the CR industry has had a few negative fall outs; among them is high attrition, unreasonable employee expectations, companies being forced to accelerate career progression, etc. This has lead to people with relative inexperience handling positions of high responsibility compared to their western counterparts. Could this impact the quality, and if so, what best practices do you adopt to tackle this?
LS: The impact is certainly there; people now expect faster growth in shorter time. It is sometimes necessary for the company to give higher responsibilities and promote people earlier than the expected period. Such situations require a high degree of management supervision. Companies should discourage this practice. Of late, professionals appear to be eager and expect fast-track career growth but, in the bargain, tend to lose out on the learning process. I would suggest young professionals to enjoy their experience and learn as they progress in their career. Expectation of accelerated growth with a fat package will hamper learning and, in turn, affect performance and quality of work. These issues need to be addressed as a part of their training in clinical research.
RS: Data management is a relatively more controlled environment with well defined processes covering each task. The amount of patient data to the global pool being contributed by Indian Data management (DM) teams is higher than that of Indian clinical teams. What quality metrics do you use to handle these massive numbers of transactions and a very large pool of personnel (some with very limited skill sets) involved? Are there any practices currently being used by DM teams that could be adopted by clinical teams?
SR: If one can look into the statistics,
RS: Hospitals in
SC: This is possible by engaging, as I said earlier, professionals who are well qualified and understand the process well. We need to build a separate team in the department that focuses only on clinical trials. In addition, the investigator and his team must develop the art of multitasking. Most importantly, good training will ensure good documentation helping the site meet quality standards.
RS: Studies in
AS: The most important factor to get the studies done at a faster rate is the proper site selection. Moreover, our experience says that the presence of a CRA at the time of first patient recruitment is critical to make the site team understand the process thoroughly as per the sponsor's requirement. Frequent meetings and regular intense training is equally important. Assistance should be provided to the trial staff as and when required. For less experienced sites, it is always better if a project manager accompanies the CRA during site visits.
RS: You have worked overseas for an extensive length of time and also in
MP: I do not think there is a difference in perception of quality per se. Though not necessarily correct, our western counterparts certainly have a perception of lower quality in
RS: Are there any pre-conceived notions on quality among our global counterparts when planning a study in
AS: There are definitely some pre-conceived notions about quality among our international colleagues. But this is quite easily addressed by arranging visits to sites, making them understand how the system functions in
RS: Companies are aggressively moving to a paperless platform and clinical trial management systems for their studies. Has this impacted quality negatively or positively? And to a larger question, when organizations transition to new technologies or standards, what steps do you take to ensure that there is consistency in the quality of operations during this transition?
SR: Deploying technology solutions allows the data to be viewed from different angles and certainly can help improve the overall data quality standards and patient safety. It is usually assumed that these technology solutions simplify the ability integrate the data across disparate sources, and hence that the data quality will automatically improve. However, in fact, the implementation requires the adoption of standards across different data sources and across trials to reap the real benefit of data integration. It also takes time for the people to adopt new technologies. Very often at clinical trial sites, it is seen that data is entered on paper and then transferred to an electronic system later resulting in delays and possibly data quality issues. We need to move to getting the data right the first time around.
LS: I would just like to add that solid training is again essential for EDC studies and it is very important to do this at the site level, too, since the systems are very precise and SOPs need to be stringently followed.
RS: FDA inspections have been very few in
SC: My suggestions would be to be realistic and transparent. We need to give an accurate picture to the auditors and do not attempt to cover up. Competitive enrollment can often be detrimental to the quality at the site as the site is then more focused on the recruitment than the quality. Further, the site needs to maintain very accurate source data. Think before you commit anything to paper and ensure that no coercion is used on any patient to make them participate in the trial.
RS: Final words on qualify for a young CR professional entering into the industry?
SR: Quality starts and ends with each one of us.
AS: Be a friend and also a policeman; focus on training.
LS: Discipline and quality go together, keep learning and growing.
MP: Be passionate about what you do, be politely assertive; you are the guardians and gatekeepers of quality in clinical research.
SC: My colleagues have said everything, and I don't have anything further to add.