Drug development entails a complex, lengthy and costly process that involves not only the Investigator but also a host of other professionals from different fields of scientific expertise. These people and their roles are summarized in the following (CBRA Fact Sheet, 2008 and Netsci.org, 2008):
Role in the Drug Development Process
determines the thousands of compounds promising enough to be considered for development; how these may be produced in large quantities, formulated into doses and properly packaged
studies the effects of the drug on molecules in animals and humans, screens the thousands of possible compounds to narrow the list to the most active
studies the effects of the proposed drug on the life processes, such as how animals and humans break down and absorb chemicals
determines the potential drug’s toxic effects on the body
evaluates the results of animal studies; establishes how the drug will work, how long, how fast and how it will be eliminated; formulates the dosage and determines stability
uses computer simulation or specialized software for drug analysis and evaluation
provides knowledge on how the body functions, how disease develops and impairs normal body functioning; monitors and determines the outcomes, including side effects, of the drug in clinical trial patients
reviews the designs of controlled studies, analyzes quantitative data, determines the validity of research results in order for conclusions to be made regarding the drug’s viability
formulates plans which lay down the targets and time frame, allots the necessary budget and resources
These professionals work as a multi-disciplinary research team and the fulfillment of their interdependent functions permits the different phases of the drug development process to be accomplished. An investigator can not work alone due to the multitude of tasks involved so that having a research team provides him with the necessary knowledge and manpower to conduct the necessary studies.
It allows him to monitor the over-all progress of the endeavor from integrating the progress reports of the members of his team and allows him to supervise the work instead of being occupied with particular tasks. Moreover, the results of the work of the research team enable the investigator to make timely and evidence-based decisions. In this manner, he is in a better position to manage or steer the direction of the research process.
The delegation of tasks decreases the scope of investigator responsibilities to: ensuring that activities are conducted according to plan, properly documented and in accordance with standard protocol; conducting a review and evaluation of the proposed drug’s safety and efficacy; preparing case reports of individual subjects; compiling and retaining all pertinent documents; complying with legal requirements including informed consent; maintaining or submitting necessary communications or reports required by the FDA and hiring additional research team members if necessary (Lee, 2007).
There are existing views that at the core of drug development and the investigator role is the profit motive and I tend to share this view. Pharmaceutical and biotechnology companies have now taken the place of the academic research institutions as leader in new drug development (Schieppati, Remuzzi, & Garattini, 2001). Consequently, majority of new drug development efforts have been and are sponsored by these companies.
As an organization with shareholders, the corporate interest is essentially what drives the initiative to discover and manufacture new drugs. Companies will not spend millions of dollars in research without a guarantee that these expenses can be recouped and that executives as well as stockholders also earn in the process. As such, the focus of research has been on the development of drugs that have high market value for a long period of time. This explains why research on drugs to treat rare diseases or the illnesses in less developed countries is not being conducted (Schieppati, Remuzzi, & Garattini, 2001).
Investigators leading a corporate-sponsored research become part of the organization as highly paid employees and often than not mirror the same ethical value. As the saying goes, “do not bite the hand that feeds you”. Because industry provides the funding for the project, they gain power to decide which studies should be conducted and how as well as allows them to manipulate the results of the studies to suit their interests as well (Schieppati, Remuzzi, & Garattini, 2001). The research process then becomes biased but not in favor of the patients who will become future consumers of the drug.
List of References
California Biomedical Research Association (2008). Fact Sheet: New Drug Development Process. Retrieved November 8, 2008 from http://www.ca- biomed.org/pdf/mediakit/CBRADrugDevelop.pdf.
Lee, H. (2007, June 12). Role of Academic Investigators in Drug Development. Retrieved November 8, 2008 from http://ctsi.ucsf.edu/files/RKS_Lee_061207.pdf.
Netsci.org (2008). The Process of Drug Development. Retrieved November 8, 2008 from http://www.netsci.org/Courseware/Drugs/Intro/slide03.html.
Schieppati, A., Remuzzi, G., & Garattini, S. (2001, November 10). Modulating the profit motive to meet needs of the less-developed world. Lancet, 358(9293), 1638. Retrieved November 8, 2008, from Academic Search Complete database.