Healthcare organizations look to the pharmaceutical and biomedical industry to continually improve drugs and devices that mitigate the risk of harm to patients while improving patient outcomes. However, building the body of evidence to support industry claims can be complicated by the risk of bias that is associated with sponsored research.
The issue of bias in sponsored research was identified as early as 1917 by Sollman in a paper discussing his experience as a member of the Council on Pharmacy and Chemistry for the American Medical Association. He noted that critical reviews by the council were affected by the lack of transparency and data produced by manufacturers on the efficacy and safety of new products. He cautioned that “Those who collaborate should realize frankly that under present conditions they are collaborating, not so much in determining the scientific value, but rather in establishing the commercial value of the article.” More recently, a Cochrane report was published that affirmed earlier conclusions that sponsored research is associated with more favorable outcomes. While the randomized controlled clinical trial remains the gold standard for clinical evidence, newer models exist to build evidence for efficacy, efficiency, and safety. The demand for transparent, unbiased, and peer reviewed findings creates an opportunity for business to business support.
Two options exist today to counter bias in sponsored research:
1. Creation of a firewall between the people conducting the research study and the funding source; and
2. Establishing entirely separate funding sources independent of the sponsor industry.
In the face of a continued decline in independent funding, efforts to responsibly maintain an appropriate distance between sponsors and researchers is increasing.
An Example of a Successful Collaborative Research Model
Recently, Visante partnered with FORCE Communications on a project to evaluate preparation time, medication errors and nursing preferences between three methods of intravenous (IV) push medication systems. FORCE Communications (FORCE) is a medical and marketing agency serving pharma, biotech, and device companies in an environment of entrepreneurial spirit, scientific understanding, industry insight, and communication savvy. This study was sponsored by Becton Dickinson Company (BD), the manufacturer for one of the IV push medication systems being evaluated.
The nature of the collaboration between Visante and FORCE was designed to take advantage of the unique depth of resources and skills available through Visante’s consultants. FORCE provided the services of an independent research pharmacist who provided the initial study design as well as data base support and statistical analysis. FORCE also managed all the logistical aspects of conducting the study.
This study used a randomized, cross-over simulation design performed in a setting that mimicked a medication preparation room in an acute care hospital setting.
Visante was able to add value to the project as a subject matter expert in medication management for hospitals and health systems. Also, the Senior Consultant participating in the study is a specialist in safe medication administration.
The following are some key contributions provided by Visante:
1. Guiding the study team on formal and informal practices for all three IV push medication systems.
2. Ensuring that the simulated medication preparation rooms were accurate and reflected current practices.
3. Selecting the study participants and location.
4. Identifying successful participant recruitment and compensation approaches.
5. Developing data collection tools.
6. Selecting and training registered nurse and pharmacist study monitors.
Data Analysis and Interpretation
1. Providing expert contextual review for data integrity.
2. Evaluating clinical and regulatory significance in addition to statistically significant results.
3. Interpreting results through an independent lens.
4. Critically evaluating unintended consequences and limitations of both the study design and results.
1. Writing results from multiple points of view to extend publication and presentation options.
2. Generating poster abstracts and speaker proposals to share results.
3. Ensuring transparency of sponsor support and unbiased findings.
In summary, pharmaceutical and device manufacturers are faced with increasing scrutiny for bias in sponsored research and this can be overcome by working with independent entities. By going beyond the manufacturer’s control and bias, these Independent entities can provide a mechanism to prevent the sponsor from influencing key aspects of clinical research such as study design, statistical analysis, interpretation, and reporting. The multiple strategies listed above may be considered by both pharmaceutical and device manufacturers as well as other agencies in this sector as important building blocks for the firewall to counter bias in sponsored research.
Sollman T, The crucial test of therapeutic evidence. JAMA 69:198-199
Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: MR000033. DOI: 10.1002/14651858.MR000033.pub2
Lexchin J. Sponsorship bias in clinical research. International Journal of Risk & Safety in Medicine, vol. 24, no. 4, pp. 233-242, 2012