Risk & Benefits in Clinical Trials

LOCHOL Study Example

The LOCHOL Study presents a number of risks and benefits. The study entails providing subjects with a 250 mg dosage of LOCHOL for two weeks. This study is designed to create a profile of the drug by assessing the pharmacokinetic, pharmacodynamic, and toxicology. The benefit of this research can be seen in the ability to quantify drug interaction and safety. This study will allow researchers to determine side effects and safety issues concerning toxicology.

There are a number of concerns with this study. LOCHOL is derived from other cholesterol- reducing agents which has been known to create a number of symptoms and side effects. These side effects include:

increase in LFTs,
myalgia,
rhabdomyolys,
muscle pain,
tenderness, or weakness and myopathy (ABC Pharmaceutical Company, 2008).

There are also a number of concerns with drug interactions such as administering the drug with: “cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, ritonavir/saquinavir, ritonavir/lopinavir, immunosuppressive drugs, azole antifungals, or niacin” (ABC Pharmaceutical Company, 2008).

Continued drug development process by following up the 2-week study with a 4-week study at 250 mg/day, based on the need for these drugs. Cholesterol is a serious issue and the need for more drugs to treat this problem is urgent. The controlled conditions of the study also present a strong testing environment which enhances the safety of the drug tests. The environmental conditions increase the ability of researchers to control dangerous situations and side effects.

References

ABC Pharmaceutical Company. (2008). A randomized , double blind, placebo-controlled, multiple dose safety and tolerance study of LOCHOL in healthy male volunteers. ABC Pharmaceutical Company. ABC Pharmaceutical Company.

Walker, D. (2004). The use of pharmacokinetic and pharmacodynamic data in the assessment of drug safety in early drug development . British Journal of Pharmocology , 58 (6), 601–608.