Data Quality in CEE:

Marcin Walter, M.D., Ph.D. Involved in high-standard clinical research since 1985, initially at St. Pierre University Hospital in Brussels, then since 1992 at Astra R&D unit in Gothenburg, Sweden. 1994-2000 in charge of operations of Astra Clinical Research Unit/Central Europe in Poland (later AstraZeneca, as Clinical Research Director). 2000-2002 Manager of Clinical Operations and International Clinical Project Manager at PAREXEL in Warsaw. Co-founder and first President of the Association for Good Clinical Practice in Poland.

Quality cannot be improved after the trial is completed
Interview with Dr. Marcin Walter, Clinical Research Director at TTL Clinical

Cathy Callaghan: Dr. Walter, Central & Eastern Europe (CEE) is already a well-established region for conducting clinical trials. There are many reports of excellent patients recruitment in these countries. Does it go together with the quality of the clinical data?

Marcin Walter: I would not hesitate to say: yes. The clinical data collected in Central & Eastern Europe are at least as credible as data coming from Western European countries. In the early nineties when clinical research started in these countries almost all investigators and study files were heavily ‘bombarded’ with Quality Assurance audits. For some years I do not remember any single study that had not been audited. And the general outcome of these audits was in full compliance with the above-mentioned statement. The percentage of critical findings observed during FDA inspections in these countries is better than that reported in Western European countries. And, finally, after years of careful evaluation of data quality, large pharmaceutical companies had decided to involve these countries in pivotal studies and key projects, with results published in top medical journals including the Lancet and the New England Journal of Medicine. Also some pharmaceutical companies established clinical research units which operate in this entire region.

CC: Is data quality a natural outcome of a well-designed study protocol or are there any additional measures necessary to ensure that we obtain reliable results from the study?

MW: The credibility of study results is one of the most important aims of Good Clinical Practice guidelines. Good Clinical Practice does not only refer to the ethics of the clinical research, the division of responsibilities between sponsor, investigator, IRBs & Regulatory Authorities, but also to the study monitoring process. The study monitor, among others, has to verify that the reported trial data are accurate, complete and verifiable from source documents. How the study monitor achieves this goal is a matter of particular skill. The monitor can simply report passively all observations in the site visit report and escalate any findings following the approved procedures but she/he can also motivate the investigators to improve quality with every new study. This should result in a higher percentage of evaluable patients vs. all patients randomized into the trial.
Here, at TTL Clinical we benefit from our experience collected in other units and we focus on quality and timelines of the clinical research process. But we also continue to develop innovative solutions to ensure the timely completion of patients recruitment and to decrease to a minimum the number of patients whose data can not be evaluated due to protocol violations or other deficiencies. Of course, the process must be continuously monitored by recording and analyzing appropriate performance metrics.

CC: Does it mean that this more complex approach ensures quality but generates higher costs?

MW: Paradoxically, the higher the quality the lower are the costs. Let’s take for example a study protocol requiring 200 evaluable patients. In one scenario due to poor quality there are only 60% of the randomized patients with evaluable data. In the second scenario there are 85% of the patients with evaluable data. If we assume per patient cost @ 3000 $ (which includes drug manufacturing cost, CRF printing cost, AE handling cost, courier, study monitor’s travel etc.) in the first scenario we need 333 randomized patients and the total cost of $1 million. In the second scenario we need 235 randomized patients and the total cost is only $ 700 thousand. Of course, one should add that poor quality clinical project also means an unethical project.

CC: How can the sponsor address quality issues when approaching a new clinical project?

MW: Every clinical project must have very accurate planning. I would say that the study preparatory phase is the most important phase in the whole project. This includes also planning for contingencies, but also careful selection of a CRO. Data quality can not be improved after the study is completed.

Interview by Cathy Callaghan