Regulatory Guidance for Subject Recruitment – LOCHOL Drug Study

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Dear Prospective LOCHOL clinical study participant,

The researcher invites you to participate in a study geared towards assessing the pharmacodynamics, tolerability, pharmacokinetics, and safety of 250 mg LOCHOL taken every day for 14 days. LOCHOL, an ester of a common agent that reduces cholesterol, has been linked to increased cases of rhabdomyolysis, myalgia, and LFTs.

th day to commence the NCEP ATPIII (Adults Treatment Panel III) TLC (Therapeutic Lifestyles Changes) Diet stabilization. You will remain on the diet through the 17th day. You will get either a single 250 mg LOCHOL oral doses or a single placebo oral dose daily for 14 days commencing from the 1stth day and after the 17th day of the study to allow for effective monitoring of the possible side effects of the drug and ensure that the study complies with the NCEP ATPIII TLC Diet. You will be allowed to leave the clinic on the 17th day. You will be assessed, or monitored, regularly for adverse events, routine safety labs, physical exams, vital signs, and ECGs.

For you to participate in the study, you should meet various criteria. First, you must be a healthy male. Second, you should be aged between 18 years and 65 years. Lastly, your LDL values should be more than or equal to 100 mgdL-1.

While partaking in the study, you will benefit from free and regular assessments for adverse events, routine safety labs, physical exams, vital signs, and ECGs. You will be expected to get enrolled into the study between January 2009 and October 2009. You are expected to make the final study visit in November 2009. The study will be executed at the CRO investigative site.

Summary of the Particular Recruitment Considerations

In the development of the LOCHOL clinical study advertisement, the relevant guidelines issued by the FDA were followed. First, in line with the guidelines, the researcher ensured that the advertisement was not coercing or misleading prospective participants to enroll in the study. Second, the researcher ensured that the advertisement was devoid of exculpatory language. Third, the researcher was keen on ensuring that the advertisement was devoid of implicit or explicit messages that would have convinced the prospective participants to that the drug has been found to be effective or safe or had been compared with drugs or treatments (Cola, Fedor & Pierre, 2006).

Fourth, given that the study entailed an investigational drug, LOCHOL, the researcher was keen on ensuring that the advertisement did not promote the drug as being a new drug, treatment or medication. Fifth, in line with the in line with the guidelines, the researcher was careful to ensure that the advertisement was devoid of implicit or explicit claims that would otherwise be incompatible with the relevant FDA labeling requirements. Sixth, in line with the in line with the guidelines, the advertisement did not emphasize payments to the prospective participants. Seventh, in line with the in line with the guidelines, the advertisement did not promise the prospective participants no-cost medical treatment (Cola, Fedor & Pierre, 2006).

 

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