What’s Pharma’s Key to Success in 2021?

What's Pharma's Key to Success in 2021? By Kathleen Hoffman, PhD, MSPH What commercial and clinical trends can we expect to shape pharma and biotech as the pandemic continues into 2021? What can your company do to make 2021 a better year? In August, Deloitte surveyed 60 marketing leaders of biopharma companies and published the findings. Fully 80% of respondents expected changes in “consumer attitudes, behaviors, and spending” to have the biggest impact on their company over the coming year.1,2 This supports Deloitte’s 2019 report anticipating a “consumer-centered future of health,” including the consumer’s increased willingness to [...]

Top 5 Ways Online Patient Communities Can Reduce the Cost of Clinical Trials

Top 5 Ways Online Patient Communities Can Reduce the Cost of Clinical Trials By Jeff Terkowitz Trying to rein in clinical trial costs? You’re not alone. A JAMA research study of 138 trials for novel therapeutics found that clinical trial costs ranged from less than $5 million to $346.8 million, with a cluster of trials coming in between $12-33 million -- and that was for trials in 2015-2016.1 Let’s agree on two things: It hasn’t gotten any cheaper, and finding qualified participants is still an issue. Here are five ways online patient communities can reduce the costs [...]

Patients Enroll In Studies When They Have a Voice: Real World Study Succeeds with Patient Voice

Patients Enroll In Studies When They Have a Voice: Real World Study Succeeds with Patient Voice By Kathleen Hoffman, PhD, MSPH The most persistent hurdle in running a clinical trial is recruiting and keeping participants. More recently, the FDA added the expectation that the value of released drugs be supported with Real World Evidence (RWE). A recently-conducted multi-center prospective observational study accomplished both by using patients as partners throughout clinical design. The PROP-UP study was a designed to collect real world patient centered data on the harms and benefits of the new, highly effective, direct-acting antiviral [...]

Real World Voice Allows Patients to be Part of the Cure

Real World Voice Allows Patients to be Part of the Cure By Claire Harter “The patient wants to be a partner in cure, just as with their doctors they want to be a partner in care.” - John Linnell, COPD Patient Advocate, talking about health literacy, eyeforpharma virtual conference, 4/14/2020 Where and how can patients partner with pharma for a cure? Where can pharma go to learn from patients about the patient experience? One resource is Electronic health records (EHRs). As a resource, they provide critical information about patient diagnosis and treatment. But, EHRs reflect the [...]

No “One Size Fits All” Solution to Improve Clinical Trial Participation

No "One Size Fits All"Solution to Improve Clinical Trial Participation By Kathleen Hoffman, PhD, MSPH Clinical trial study designers are trying to find ways to increase participation and reduce dropout. According to three recent studies, the reasons patients give for not participating in clinical trials vary depending on a number of factors including the condition being studied, the gender or age of participants, and even minority status. Accommodating these differing needs in the study design would support enrollment and sustain participation, but it requires asking prospective participants what would lower the barriers for their specific condition [...]

Where Can I Get This ‘Real World Data’ You Speak Of?

Where Can I Get This ‘Real World Data’ You Speak Of? By Robert Gardner How far has the importance of Real World Evidence advanced as part of treatment development? When the attendees of a recent eyeforpharma webinar were asked, “Are you, or will you soon be using RWE for enabling new types of value or outcomes-based assessment within your own firm?” 35 percent responded that they already consider RWE “a universal and necessary standard,” with another 26 percent saying RWE is or will be used as evidence in developing “specialty and high-priced treatments.” A “universal and [...]

Patient Centricity: Joining Qualitative with Quantitative

Patient Centricity: Joining the Qualitative with the Quantitative By Kathleen Hoffman, PhD, MSPH Reams of market research and data can provide insight, but so can one patient in the room, telling you what really matters to them.1~Paul Tunnah, PharmaPhorum founder The FDA’s drug approval process requires developers to submit quantitative data demonstrating that the treatment is safe and effective after testing in a representative target population. But if you’re accustomed to using quantitative studies to attain approval, you might be feeling jaded about patient centricity guidances. As Tunna’s article says, “...everyone seems keener to shout about [...]

Rethinking patient engagement in clinical trials: Be part of the solution

Rethinking patient engagement in clinical trials: Be part of the solution By Kathleen D. Hoffman, PhD Seated in the waiting room of a large medical center, I overheard the bright eyed, young man behind the reception desk ask a new patient, “Would you like to learn more about participating in our research?” I smiled and thought, this is part of the solution. But it is a small part. I’ve been going to the same clinic for five years and today is the first time I’ve heard this question. I wondered if anyone would ask me - [...]

How R&D Teams Can Use Patient-Centricity for Clinical Trial Optimization

How R&D Teams Can Use Patient Centricity for Clinical Trial Optimization By Monica St. Claire In 2014, Tufts Center for the Study of Drug Development performed a comprehensive assessment of the use of social media and digital technology in clinical research. This forward-thinking study revealed that pharmaceutical, biotechnology companies and contract research organizations (CROs) had not implemented strategies to effectively utilize and capitalize on the patient and caregiver content available.1 Today, Inspire’s products and services address these clinical trial optimization essentials. Specifically, our tools provide pharmaceutical and biotechnology companies’ research and development (R&D) teams as well [...]