Saturday, February 27, 2010

Budgeting Impact on Superfluous Clinical Trial Data

In the previous post, we spoke about superfluous collection of clinical trial data and its impact on clinical trial integrity and quality, extra unnecessary data, increased patient dropouts, increased costs, missed timelines, under-resourced departments, etc. The remedy remember is to involve team players and biostatisticians early on the clinical and regulatory path to design a clear-cut protocol with achievable clinical outcomes that are medically meaningful and statistically significant. In other words, design a SAP, statistical analysis plan, that is precise.

Budgeting - patient recruitment can also help in the reducing unnecessary data collection. At the outset of patient recruitment, pharma must first determine a number of factors about the clinical trial that will influence cost, time and yes, data. The budget, the number of patients recruited and the amount of patient data collected are closely linked. All 3 will be influenced by:
  • how many patients are needed for the clinical trial
  • how many patients must be screened to randomize the required number of patients
  • how many investigator sites will be involved in the clinical study and where will they be located
  • what percentage of patients is the investigator site capable of recruiting and what percentage must be recruited by the pharma, CRO
  • is this a pivotal clinical trial seeking results for a new drug application (NDA)
  • how experienced is the pharma at recruiting patients in the therapeutic area in question
  • how long is the clinical trial expected to last
  • how restrictive are the patient inclusion/exclusion criteria outlined in the clinical study protocol
  • are there alternative therapies already on the market.

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