clinical trials patient recruitment

2.4.2014 Clinical Development

Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

By Sarah Ray, 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...
 

10.10.2013 Clinical Development

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

By Sarah Ray, 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...
 

7.2.2013 Clinical Development

Verastem Attacks Cancer Stem Cells with Investigative Mesothelioma Treatment

By Jennifer Harrell, Research Analyst Biopharmaceutical company Verastem discussed its lead compound and the future of mesothelioma treatment at this month’s ASCO Annual Meeting presentations.  Development of the compound, VS-6063, represents...
 

4.18.2013 Clinical Development

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...
 

3.19.2013 Clinical Development

Oncology Spotlight: Using Companion Diagnostics to Drive Patient Recruitment

Many companies have launched successful exploratory and investigative clinical trials targeting oncology.  Clinicaltrials.gov lists 24,710 active cancer trials during the past 10 years.  Specifically, 1,763 non-small cell lung cancer trials were conducted over...
 

2.28.2013 Clinical Development

Oncology Spotlight: Abraxane May Earn Approval for Third Indication

Celgene Corp. recently released positive Phase 3 data for its cancer drug Abraxane in combination with gemcitabine (Lilly’s chemotherapy drug) for the treatment of advanced pancreatic cancer.  The Abraxane study, nicknamed MPACT (Metastatic Pancreatic Adenocarcinoma...
 

2.25.2013 Clinical Development

Oncology Spotlight: Galena’s NeuVax Phase III Breast Cancer Trial

Portland, Oregon-based Galena Biopharmaceuticals has begun recruiting breast cancer patients for its Phase III PRESENT (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial. ...
 

2.21.2013 Clinical Development

Planning for Phase 1 Costs: Don’t Leave the Patient Behind

When planning Phase 1 trials, there are many high profile cost-drivers — from patient recruitment to CRO contracting.  For many therapeutic areas, these functions will require the most money and time on the part of the clinical trial team.  However, for the...
 

1.30.2013 Clinical Development

Save Time and Prevent Delays: Set Solid Plan at Start of Phase I

The pharmaceutical industry is feverishly searching for the next big drug to replace lost revenue from patent expirations on major blockbuster medicines.  Drugs with more than $30 billion in annual revenue lost patent protection in the last two years.  Patent...
 

1.23.2013 Clinical Development

Phase IV Patients Are a Virtue

Finding patients in a very specific disease state is difficult enough, but in the shadow of Phase III, it’s nearly impossible.  In fact, next to Phase IV, Phase III patient enrollment looks easy.  Phase IV patient recruiters are stuck competing not only with...