Risk-Based Monitoring Strategy: Embrace Centralization Technology to Save Resources During Clinical Trials

Victoria Cavicchi, pharmaceutical clinical trial researcher
By Victoria Cavicchi,
Research Analyst

Risk-based monitoring (RBM) has recently emerged in the pharmaceutical industry as a way to reduce the costs of clinical trials while maintaining, or even improving, site protocol compliance and communication. In traditional trials, sponsors visit clinical sites frequently — often every four to eight weeks. However, these in-person site visits and monitoring strategies account for a large percentage — a suggested 30% — of clinical trial costs.  A risk-based monitoring strategy — especially when combined with in-person visits — conserves time and staffing resources while still enforcing good clinical practices. Continue reading

Clinical Trial Staffing: Recruiting CRAs Best Suited to Trial Needs

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Clinical research associates (CRAs) are a crucial part of a companys clinical trial staffing. CRAs often work as a liaison between the company and investigator sites, ensuring that the trials run smoothly. As such, CRA responsibilities range from tracking patient consent forms to monitoring patient data and visiting investigator sites. Cutting Edge Informations recent study on clinical trials finds that when recruiting CRAs, companies consider a number of qualities, including: Continue reading

All Right, Meow: Patient Recruitment for Animal Health Studies is Serious Business

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Team Leader

Patient recruitment isnt just human subjects. Cutting Edge Information has conducted a number of clinically focused projects, examining an array of industry challenges.  How companies recruit for their clinical trials — including what works and what doesnt — is a hot topic for clinical stakeholders.  A recent CEI study on patient recruitment highlights the percentage of companies conducting activities and who specifically —trial site, sponsor or CRO — is coordinating these activities. Continue reading

Including Personalized Medicine in Clinical Trial Budgeting: Worth the Cost?

Personalized medicine may change the way healthcare is provided, increasing the benefit of interventions to patients who need them most. Despite this excitement, it is important to consider that personalized medicine will also significantly impact the way clinical trials are designed. These changes will push the total cost of clinical trial upward. Companies should plan for a bigger bottom line when engaging in clinical trial budgeting to reap the rewards of shifting toward personalized medicine.  Continue reading

Selecting the Right Vendor for Phase I Clinical Trials: Preferred Provider List or Bidding Process?

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Phase I clinical trials are supposed to be the quickest, easiest trials with the simplest question in mind: will the drug harm the patient?  No? Good, then you may proceed. However, sometimes the trials are not as straightforward as all that – there can be problems in recruiting, sites can drop out, etc. For many companies, a good way to expedite Phase I trials – and save a little money – is to use contract research organizations (CROs) to administer the trial. In fact, surveyed drug companies outsource 70% of Phase I trial costs. Continue reading

Making the Most of Scientific Advisory Boards with Clear Objectives

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

When bringing together a group of active clinicians and specialists for a scientific advisory board, companies should make sure to maximize the effectiveness of the resources seated around the table.  Each person in the room has a different set of experiences, all of which are invaluable to the clinical trial being discussed. The process of converting this aggregated knowledge into a better product is what differentiates an average advisory board from a truly successful one. Continue reading

Clinical Trial Management: Risk-Based Monitoring Represents Viable Oversight Solution

Sarah Ray, clinical trial management researcher
By Sarah Ray,
Senior Research Analyst

With the growth in companies pipelines, clinical trial management becomes essential. One aspect of study oversight, monitoring trial risk, has evolved in recent years.  In traditional clinical studies, clinical research associates (CRAs) typically visit each investigative site every four to eight weeks. However, regularly scheduled visits are fairly uniform in nature and do not always consider site experience and level of patient enrollment — factors which could potentially define a site as being either higher or lower risk.  Conceivably, under this type of structure, CRAs could visit sites that hadn’t enrolled a single patient — and do so with the same frequency as sites with high patient volumes. Continue reading

Roche’s Bad News Emphasizes Clinical Data Transparency and Patient-Reported Outcomes

Roches recent announcement about the failure of its schizophrenia drug, Bitopertin, highlights two hot topics within pharma: clinical trial transparency and patient-reported outcomes (PROs). The drug failed to meet primary endpoints in two Phase III trials designed to test Bitopertins efficacy in reducing negative symptoms in schizophrenia patients.  The decision to announce the failure indicates a growing trend by pharma towards increased transparency of clinical trial data results.  In an effort to improve pharmas reputation among an increasingly distrustful patient and physician population, companies are increasingly deciding to publish both positive and negative trial results.

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