Subject recruitment

While clearly outlined criteria are essential, a lengthy list of exclusions can also impede subject recruitment. Therefore, a balance must be struck between what is scientifically desirable and that which is still practical with regard to the number of study sites and length of time required to complete the trial. 

Surveys of professional lawn chemical applicators were conducted during the summer and fall of 2004. Subjects recruited included participants in Ohio State University s OARDC (Ohio Agricultural Research and Development Center)-sponsored turf care professional educational seminars (Northeast Ohio Lawn Care Seminars). Approximately 300 professionals attended these events (held at the Wooster campus of Ohio State) to inform practitioners of best management practices, new technology, and health and safety issues. Participants included those who own and work in the lawn care industry in Ohio, spanning companies from small, one-person owner operated firms to large franchised national outfits. Professionals attend these seminars for purposes of certification participation in the survey was optional. 

It has been traditional in the United States to dose individual subjects just once, with a new cohort of subjects recruited for each dose level. In Europe first administration studies have more often involved dosing individuals at several if not all dose levels tested in a study. 

Subject recruitment, including providing informed consent. 

The Ethics section of the protocol deals with the fundamental requirement for prospective IRB/IEC approval of the trial protocol, protocol amendments, informed consent forms and other relevant documents (e.g. subject recruitment advertisements). 

Suitable study subject population, for example access to suitable subjects in sufficient numbers method of subject recruitment source, for example from investigator s subject population, or be referred by other physicians and, if referred, means by which investigator will obtain adequate evidence of medical history use of advertisements potential subject enrolment (recruitment) rate... 

Evaluate the subject recruitment and withdrawal/dropout rate. If recruitment is less than optimal, suggest ways in which it can be increased. In particular, query the reasons for withdrawals/dropouts, or unscheduled visits, in case these are related to AEs... 

There are a number of good reasons to conduct phase III trials as multicenter trials. The most obvious is an administrative and logistical reason. Spreading the burden of subject recruitment among many centers will reduce the duration of the subject enrollment phase of the trial. This is an important reason considering that often the key to commercial success or failure of a new drug is the timing of its introduction to the market. There are also important scientific reasons to conduct the trial as a multicenter trial. 

How much information is necessary for potential subjects to be informed Should investigators tell the subjects how much money they are compensated per subject recruited It is probably unnecessary for subjects to understand how clinical research is funded (e.g., overhead fees, fees for certain services), unless this information would influence any reasonable person to participate (or not to participate). The pharmacy profes-... 

The IRBs should review research funding for appropriateness and possible coercion, specifically as it applies to subject recruitment. If the amount of payment is so high as to induce any reasonable person to participate, regardless of the risk, it is obviously too high. It becomes difficult, however, to determine when coercion is present because the majority of cases are not this obvious. Investigators should be able to justify any payment to... 

Subjects Recruitment internal or external to institution Compensation awarded or not Is subject focus of research ... 

The number of subjects to be recruited for the study should be estimated by considering the standards that must be met. It should be calculated by appropriate methods (see statistical analysis and acceptance criteria below). The number of subjects recruited should always be justified by the sample-size calculation provided in the study protocol. A minimum of 12 subjects is required. 

There is a critical need for statisticians to develop inferential analysis models that are valid in the face of the realities of nonrandom subject recruitment. In addition, there is a need to consider whether the current trend toward highly selective inclusion and exclusion criteria for clinical trial subjects should be reversed to allow a more representative sampling frame. 

The investigator is responsible for the accuracy and completeness of then trial records and any discrepancies found in these records during an audit (ICH 4.9.1). The monitor will review the source documents for accuracy and completeness against the CRFs at each monitoring visit and will provide feedback on their acceptability to the investigators and their staff. Once the initiation visit has occurred, the study site is considered officially started and subject recruitment can begin. 

There are several other key components to trial execution that will require special attention subject recruitment, the informed consent, IRBs/IEC review product accountability, adverse experience and adverse reaction reporting, financial disclosure, and record retention. Each is critical in the overall success of a clinical trial. If one of these is not handled or processed appropriately, the clinical trial will not be used in support of a new product application. Many of these components have been discussed previously in the context of monitoring. Adverse experience and adverse reaction reporting, informed consent, and IRB/IEC are detailed in Chaps. 11 and 20. The remaining key components relative to managing clinical trials will now be addressed. 

The privacy to subject information that HIPAA commands is not totally unjustified, especially in the world of telecommunication we live in. However, it will put a great burden on investigators and sponsors who conduct clinical research in the process of new product development. This could delay the research progress that brings new products in the pharmaceutical field to market. One of the biggest obstacles in completing clinical research in a timely manner is the difficulty of adequate subject recruitment. HIPAA is another obstacle that could interfere with this essential step in conducting clinical research. 

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