LABORATORY INFORMATICS
GMP manufacturers can be inspected by regulators at any time, with no notice (some notice is required for foreign inspections)
manipulate data when they are rewarded (or, not punished) for doing it. A lab scientist can be pushed to
misconduct when a deadline looms and the ‘right’ result is needed, or someone’s pay/position will suffer. If the ‘wrong’ result is reported, the material must be discarded (manufacturing), or the experimental thesis abandoned and/or revised (research). For both manufacturer or researcher, money and time are lost. The manufacturer must have new batches of medicines to sell for profit, while the researcher needs data to stay ahead – the ‘publish or perish’ challenge of research. Since both manufacturer and researcher share similar motivations to achieve desirable data on a schedule, data integrity issues in one (manufacturing) makes it likely that similar issues exist in the other on an equal basis (research).
The lack of original data review, and the lack of a requirement to retain all data – even data not included in a summary – collectively permit a scientist to test and retest until a desired result is obtained, then to ignore or delete all other data values and report the desired one.
Inspection (reason four) GMP manufacturers can be inspected by regulators at any time, with no notice (some notice is required for foreign inspections). Once in the facility, they can look at anything and interview anyone involved in manufacturing. Forensic data inspections can be conducted, and regulatory bodies (such as FDA, MHRA, EMA) have experts they bring for these inspections. The FDA attempts to inspect firms about every two years, although requests to market a new drug nearly always result in an inspection prior to an approval to market. It is not uncommon for large pharmaceuticals to be inspected a dozen or more times by different global regulators within a year.
www.scientific-computing.com | @scwmagazine
In contrast, research labs might be inspected for safety by university personnel, by a local committee, or perhaps by a certifying authority (if certified at all), but they have no inspection authority looking at their operation in detail, unless a ‘for cause’ is initiated by a local committee. This lack of direct, independent, detailed oversight provides an environment where misconduct can continue for extended periods without discovery.
Similar motives (reason five) Research labs and QC labs that test pharmaceuticals have similar motives, which means that they will have similar reasons to manipulate results to be more favourable to them. QC labs perform mostly routine tests, using written procedures and analytical equipment often configured to efficiently do one job. By contrast, research labs reconfigure their lab equipment for each experiment, and seldom use written procedures. So how could they be the same? Motive is the answer, and the problem. People will
Driving the engine of change: who will do it ? Given the high percentage of indirect evidence of research misconduct, the lack of data forensic inspections and independent oversight of research labs, the lack of requirements for strict security and access controls to data management systems, research labs appear to be more at risk than GMP manufacturers for misconduct, manipulation and hiding of data. So what will cause the issue to be exposed, and how will the improvements in data integrity be pushed into research? Will it come from governments, NIH, publishers or the universities themselves? Will it be voluntary, tied to standards or external accreditations, or codified as law? Misconduct also raises questions about all those studies that are contradictory: coffee is bad for you, it is good for you, etc. Is the problem a lack of statistical power in the data, or was it due to data selection, trying to support an unsupportable hypothesis?
Reference [1]
Gupta, Ashwaria. Perspectives in Clinical Research. 2013 Apr-Jun; 4(2): 144–147.
www.ncbi.nlm.nih.gov/pmc/articles/ PMC3700330/
August/Septemebr 2018 Scientific Computing World
23
ISOVECTOR/ Yevgenij_D/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36
