Considerations for Conducting Clinical Studies on Metabolic Conditions
By Stephan Voswinkel, PhD
MLM Medical Labs Managing Director of European Operations
With the proliferation of metabolic-related diseases such as diabetes, biopharmaceutical companies are working to develop new therapies that address these conditions. Companies large and small are expending precious resources to find treatments for people who have developed diabetes to lessen the likelihood of serious complications such as diabetic retinopathy, coronary artery disease and stroke.
As companies compete to develop critical new therapies, they will encounter a myriad of clinical research obstacles that, if not properly managed, may delay their study’s progress or completely shut down promising clinical trials.
As a company that has conducted more than 300 diabetes related studies, MLM has a unique understanding of what it takes to successfully develop new metabolic-related therapies. When biopharmaceutical companies select clinical partners, there are 3 main areas that they should focus on before selecting central and specialty laboratory.
Select a laboratory with available validated diabetes-related assays and biomarkers
Working with a lab that has an extensive library of approved diabetes-related assays and biomarkers can dramatically streamline study design and execution. Eliminating the complex and laborious task of creating and validating new assays will reduce the burden on clinical scientists so their skills can be used in other vital areas. This also means that companies will not need to pay for the expense of assay validation, which can result in a significant cost savings.
A large portion of MLM’s library of nearly 1000 validated assays were developed for diabetes studies. This extensive experience gives MLM’s partners a significant head start in the race to develop novel therapies for diabetes. Visit MLM’s assay menu to look at the expanding catalog of testing parameters currently available.
Work with an experienced team of researchers familiar with metabolic research
A team of scientists and researchers skilled in metabolic-related diseases can provide vital assistance in study design and setup. When not properly developed, study designs may fail to provide the data needed to determine the next course of action for therapy development. The National Institute of Health cites poor study design as a major reason scientific articles are rejected by peer reviewed journals. Poor study design could also impact drug approval from EMA or the FDA.
In the more than 300 diabetes-related studies that MLM has conducted, MLM scientists have been instrumental in helping to design studies that provide the data required for study sponsors to make informed decisions on the next steps of a drugs development.
Ensure that laboratories can provide qualified accurate results
When committing to a central laboratory for a diabetes study, it’s imperative that the laboratory share your commitment to provide accurate data. Most central labs are not equipped to conduct the most common measurement used to determine long-term glycemic control in people with diabetes mellitus– Hemoglobin A1c (HbA1c). Because equipment required for accurate and precise HbA1c testing is expensive and requires regular maintenance, many labs elect to use less precise, less accurate and less expensive methods.
MLM is one of the few central and specialty labs that gained Level 1 Certification on HbA1c accuracy by the National Glycohemoglobin Standardization Program NGSP.
In the competitive area of metabolic drug development, biopharmaceutical companies need to look for an advantage wherever possible. Working with the right central lab partner can profoundly impact speed of discovery and help prove efficacy. Seek out a lab partner that has extensive experience developing diabetes drugs to give your company the best chance for success.