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 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

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.  The trial will test the effectiveness of their vaccine therapy, NeuVax, in preventing recurrence of breast cancer.  The target patients have previously achieved remission thanks to standard-of-care therapies but are node-positive (cancer cells have been found in the lymph nodes).  The vaccine is ideal for patients who express low to intermediate HER2 levels, a protein that is over-expressed in many forms of cancer.  The vaccine trains the body’s immune system to attack cells expressing HER2 that could trigger relapse. Continue reading

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 therapies (generally orphan drug candidates) that recruit affected patients into Phase 1 trials, the sponsor company must understand and account for post-trial care while planning trial duration and cost. Continue reading

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 expirations — and the accompanying lost revenue — place great strain on all areas of the company.  Much of that burden falls to clinical development teams charged with ushering investigational medicines to market.  Phase I is an important step for investigational compounds on the journey to regulatory approval.  But Phase 1 trials are not as straight forward as they once were. Continue reading

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 their competitors’ large-scale Phase III trials, but also with their own company’s later-stage studies. Continue reading

Companion Diagnostics: A Growing, Beneficial Trend for Pharma

The drug industry’s reliance on companion diagnostics (CDx), particularly among large companies, has grown in recent years. According to the BasePair Group, CDx Partnerships with pharma have more than doubled between 2011 and 2012. Cutting Edge Information found in its study, “Companion Diagnostics and Biomarker Development: Partnership Strategies and Benchmarks” that 38% of surveyed companies had plans to launch a CDx in the next year. Continue reading

Accelerating Phase 4 Clinical Trials a Matter of Improving Enrollment

Phase 4 clinical trials not only serve to gather valuable data surrounding drugs’ safety, tolerability and real-time effectiveness, but also to test potential new indications, develop stronger marketing profiles, gain payers’ favor and prove superiority over competitors’ products. While many phase 4 trials are conducted at the requirement of regulatory agencies, many are conducted simply to help boost products’ profiles. Needless to say, these trials can be particularly pertinent to the success, or failure, of a product regardless of the reason. Continue reading