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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :Finding principal investigators crucial to recruitment; report.. 2009-10-14 01:12:40 
M.Anusha
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Joined: 2009-07-29 10:23:16
Posts: 9
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Hello,

CROs believe that finding the right principal investigators is the hardest part of recruitment, according to a survey that adds that 80 per cent of respondents would prefer to reach enrolment goals 10 per cent quicker than cut costs by 20 per cent.

Desire from pharma, and consequently contract research organisations (CRO), to shorten drug development time has increased focus on patient recruitment, which is viewed by some as an industry growth rate-limiting factor.

These issues are tackled in a report by Industry Standard Reports (ISR) that interviewed 362 stakeholders, including patients, investigators, CROs and pharmas, to analyse the challenges of recruiting for clinical trials.

From these interviews ISR believes that CROs and pharma sponsors believe finding the right principal investigators is the hardest part of patient recruitment. However, principal investigators disagree, stating that limited patient awareness is currently the most challenged obstacle.

The view of principal investigators is supported by the responses of 119 patients, 75 of whom were trial naïve. When interviewed 70 per cent of trial naïve patients said they were yet to participate in a clinical study because they were unaware of opportunities to do so.

Fortunately for pharma 80 per cent of this group are at least “somewhat interested” in participating in a clinical trial, with 25 per cent of respondents saying they are “extremely interested”.

Improving communication with these potential participants could help the industry achieve a goal highlighted in an earlier ISR report that found 88 per cent of respondents would prefer to reach recruitment goals 10 per cent quicker than cut Phase II/III costs by 20 per cent.

Responsibility and communication

The survey also probed the interactions between principal investigators, pharma sponsors and CROs. From this ISR found that principal investigators believe increased interaction between them and study coordinators would significantly improve the likelihood of trial success.

However, of those interviewed 70 per cent said that they are never or almost never asked their opinion on how to improve the clinical trials they are managing.

Regarding the outsourcing of clinical trials 75 per cent of sponsor companies indicated a willingness to allow CROs complete control over site selection and patient recruitment in exchange for a guarantee of trial success.

regards

anusha
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