Clinical Trial: Outsourcing & Associated Contracts

Clinical Research

The cost of bringing a drug to market is tremendous and in order to create a company for an Alzheimer’s drug it will be necessary to conduct a clinical trial. Conducting a clinical trial is a complicated and time consuming process. In this case the clinical trial will need to be conducted once the company has formed for the new drug. The company will be conducting the clinical trial, but will need to hire or appoint someone to be the principal investigator. Depending on how the company is formed, there may be a sponsor involved who will be the person or organization which hires the investigator (US National Institutes of Health, 2015). The investigator will conduct the clinical trial and be the primary individual who is responsible for the design of the trial (US National Institutes of Health, 2015).

If the clinical trial is federally supported or the drug is FDA controlled this will mean that an institutional review boards (IRB) will be needed to review, monitor, and approve the clinical trial. The IRB will be composed of “physicians, researchers, and members of the community” (US National Institutes of Health, 2015). The IRB will be appointed by either the Food and Drug Administration or the Department of Health and Human Services. The IRB is regulated by the Office for Human Research Protections (OHRP), these agencies will need to be contacted (US National Institutes of Health, 2015). Should the clinical trial be moved overseas, than the United States Department of Defense will need to also be contacted (US National Institutes of Health, 2015).

Beyond the regulatory aspects of conducting the clinical trial, it will be necessary to contact a facility such as a clinic, hospital, or university for obtaining a place to conduct the trial (US National Institutes of Health, 2015). Due to the clinical trial being a drug, it will likely need to be done in a hospital or in a clinic. This will mean that healthcare professionals such as doctors and nurses will be needed. Larger hospitals will likely have the needed space and facilities for a clinical trial.

References

US National Institutes of Health. (2015). About Clinical Trials. Retrieved from Clincial Trials: https://clinicaltrials.gov/ct2/about-studies/learn#WhoConducts

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