Finding the Patient Voice in Clinical Trials

The gold standard for evaluating risks and benefits of pharmacologic and non-pharmacologic therapies in an unbiased manner is a randomized, controlled clinical trial. However, despite the advancement of clinical trials, many lack one essential component to success: Patient voices. How can pharmaceutical companies claim to truly understand the risks and benefits of their therapies without fully engaging with the targeted patient base?

A survey conducted by the Clinical Trials Transformation Initiative and the Drug Information Association found that only 45% of 119 predominantly large pharmaceutical companies engage with patient groups. More surprising, 41% said they had no plans to engage with patient groups in the future. A thorough understanding of disease burden, risks, benefits, and therapeutic outcomes from the patients’ perspective should serve as a foundation for the development of clinical trials. However, the patient voice is often added after trial...

Health Disparities In Our Genes: An Asthma Story

Despite significant advances across many areas in healthcare, asthma continue to be a disease of nearly epidemic proportions. One in every 13 people has asthma and almost 6.3 million people who suffer from asthma are under the age of 18. African Americans and Hispanics suffer more frequently from asthma than Caucasians. Disturbingly, African Americans are three times more likely to be hospitalized and die due to asthma complications. Why? We know that several factors impact healthcare in minority populations. Among those variables, access to healthcare and insurance, income, language and literacy barriers, and environment are at the top of most lists. But is there something more? Is there something at the very core of our genetic make-up that impacts how we as individuals respond to different medications and treatments? As we have learned in many other disease states, such as oncology and cardiology, the answer is clearly yes. In asthma, that genetic difference leads to an alarming...

Increasing Diversity in Drug Clinical Trials

Historically, the recruitment of minorities in drug clinical trials has been a major issue. Possible barriers to the inclusion of minorities in clinical trials include physician triage, physician’s knowledge of clinical trials, patients’ fear or mistrust of the medical community, and trial participation burden. Overwhelmingly, clinical trial results lack representation of target patient populations, and in some cases, the very patient populations most likely to benefit from new therapies. Despite the underlying factors related to recruitment issues, adequate representation of minorities in clinical trials is essential for thorough understanding of a drug product before it is approved for use in the general population.

On May 27, 2016, AXUMIN (fluciclovine F 18) was approved by the FDA for the detection of prostate cancer recurrence. The majority of participants in the clinical trials were white (31%) and 65 years or older (66%). According to the CDC, black men have the...

Global Breast Cancer Market to Grow at 58.3% CAGR to 2023

According to a new market research report by Transparency Market Research, the global breast cancer therapeutics market was valued at $55.5 million in 2015 and is estimated to reach $7,853.1 million in 2023 at a CAGR of 58.3% from 2015 to 2023.

Breast Cancer Therapeutics: Pipeline Analysis Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2023 states that, among all the pipeline drugs in phase III, Puma Biotechnology's Neratinib is estimated to generate maximum revenue by 2023. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, or EGFRs, HER1, HER2, and HER4.

Pfizer's Palbociclib + Fulvestrant is reported to be...