Developing Successful Patient Recruitment Strategies Means Never Underestimating the Value of Market Research

Sarah Ray, clinical trial patient recruitment strategies researcher
By Sarah Ray,
Senior Research Analyst

Historically, clinical development sponsors — along with trial sites and CROs — have struggled to recruit sufficient numbers of patients for their studies. In some cases, this challenge owes to a sudden influx of trials that target the same patient groups. For example, more than one pharmaceutical executive has worked with sites that are running concurrent studies — each with similar enrollment criteria. In others, problems recruiting sufficient participants boils down to an inability to cater patient recruitment strategies to patient perspectives. 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 isn’t 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 doesn’t — 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 trials upward. Companies should plan for a bigger bottom line when considering personalized medicine and clinical trial budgets to reap the rewards of the changes.  Continue reading


Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the AllTrials initiative, many companies are determined to become proactive when it comes to data disclosure.

Over the past decade, various patient advocacy and regulatory clinical data stakeholders have pushed for greater transparency. Under the FDA Amendments Act of 2007, companies in the US have until 21 days after the first patient is enrolled to register their clinical trial on ClinicalTrials.gov. These teams also have up to one year after their clinical trials conclude to post results. More recently, in Europe, the EMA released an updated version of the European Clinical Trials Database (EudraCT) which aligns its summary results with those already found on ClinicalTrials.gov. Continue reading


When Reinventing the Wheel Is a Good Thing: Developing New Mechanisms of Action to Target Unmet Medical Needs

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

With another patent cliff looming, many pharmaceutical and biotechnology companies are expanding their clinical pipelines — be it to incorporate new therapies, to concentrate on niche areas or to develop new mechanisms of action (MoAs).  Often, companies develop these strategies to address existing unmet medical needs.  From companies clinical structures to their marketing strategies, its common knowledge that one size rarely fits all.  In the same vein, rarely does a single MoA effectively treat all patients within a disease state.

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Minimize Phase I Clinical Trials Delays with Early CRO Communication

Staying on schedule with planned timelines is both essential to maximizing a product’s potential and monstrously difficult to achieve.  New data that we’ve compiled in a recent study (see Figure 1) show an average of more than five months’ difference between planned and actual trial duration.  It’s clear that most of these phase I clinical trials delays are during patient enrollment, whether from low enrollment rates alone or amendments that companies end up making to the study protocol.  The exact problems that a clinical trial team runs into depend on the therapeutic area, the locations and abilities of the study sites.  But the clinical team should not discount the potential of its own expectations and communication methods to cause problems. Continue reading