The British Broadcasting Corporation (BBC) recently reported on the initial success of an ongoing, international study, conducted by Bristol-Myers Squibb. The randomized, double-blinded Phase 3 study enrolled 945 patients, each with previously untreated, advanced melanoma. Continue reading
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
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
Patient recruitment is one of the biggest challenges facing companies involved in oncology clinical development. For example, a recent study by Cutting Edge Information finds that only 43% of surveyed companies achieved planned Phase 2 oncology enrollment. Recruitment problems can greatly delay clinical trials – sometimes by as long as 20 months – and these delays cost the company and deny oncology patients much-needed treatments. If only there were some avenue through which companies could reach large communities of patients just perfect for their trials. Continue reading
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
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
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.
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, the Verastem mesothelioma treatment, represents an increasing focus on targeting cancer stem cells (CSCs) as researchers examine their potentially crucial role in tumor treatment. Continue reading
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
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 the past decade —1,057 of them Phase 2 trials. Continue reading