Healthcare research manifolds a high value as it grasps the ability to deliver precise data related to disease trends and underlying risk factors, enabling clients to use this information about patterns of care, treatment costs, unmet patient needs, and more to develop and provide crucial pharmaceutical and medical device products.
Scientific research organizations (SROs) also conducting pharmaceutical market research provide a valuable adjunct to the clinical trials that precede launching of medical products. While clinical trials prospectively track a selected sample of patients to measure efficacy, adverse events, and other outcomes pre-launch, SROs can help during pre-launch by studying a nationally representative, retrospective sample of treating physicians and their patients to size the potential market through epidemiology or see how a condition is currently being treated before a client’s own drug launch, helping the company to answer unmet needs, attract investors, and find a marketing niche.
Post-launch, similar treating physician/deidentified patient records studies can capture real-world evidence of how the product is being used in the field, how quickly the new drug is being adopted, clinical utility, efficacy, dosing and titration trends, adverse events, how it compares with the competition, and much more.
Quasi-experimental research such as propensity score matching studies can take retrospective, observational, anonymized patient data and match two groups of patients, for instance, one receiving the client’s product and the other, a competitor’s product, by key characteristics to compare outcomes between patients with matched (highly similar) profiles.
All such research plays a vital role in recording and assessing familiarity of conditions and new treatments in clinical practice to improve strategies for best practices and ensure high-quality patient care. Collectively, scientific and clinical research organizations have helped the industry in developing important new therapies, enabling a notable improvement in the healthcare sector.
Clarity Pharma Research® LLC is an SRO serving pharmaceutical, medical device and biomedical companies with an established definition for quality that begins with identifying short- and long-term decisions, problems and opportunities for which a client is responsible.
Under the leadership of Dr Jack R. Gallagher, Founder, and Susan Carroll, Managing Director and Owner, the firm is dedicated to a sustainable corporate concept of “reciprocal personal well-being.” The company’s mission is to provide accurate, relevant, timely and cost-effective research and recommendations that enable its clients to make informed and optimizing decisions.
The development of an entrant to the atypical antipsychotic pharmaceutical market is a prime example of Clarity’s success in helping clients navigate through a landscape of awaiting fierce competition by working in tandem with the client’s in-house drug and brand development teams both before and after a drug’s launch into the marketplace. Clarity’s combination of qualitative interviews and quantitative, fact-based survey research played a central role in guiding the drug’s success. Pre-launch research provided insights to enable the drug to meet sales forecasts for the post-launch period. Post-launch, Clarity’s team and the client worked closely to leverage annual research into effective strategies, resulting in a product that maintained a high level of financial contribution to the client for many years.
An Inspiring Beginning
Dr Jack Gallagher founded the company after leaving the faculty of the University of Virginia Medical School, where he directed a multi-university research consortium and taught medical residents, fellows, and other graduate students how to evaluate, interpret and recognize flaws in published research, particularly what he calls the silent killer of survey research: biased samples. He also lectured on epidemiology at other universities. During that period, he realized that medical research in general, and pharmaceutical market research in particular, was rife with this usually undiagnosed slayer of study validity.
Thus, it became clear that a substantial market existed for a pharmaceutical market research supplier that is dedicated to and successful at minimizing such study validity-destroying biases. This realization provided him the source of inspiration for starting Clarity Pharma Research® LLC.
Clarity is a unique pharmaceutical market-research-focused organization that provides scientifically valid answers to vital strategic questions about the epidemiology, patient history, and treatment of patients with various medical conditions, particularly those with cancer and/or with rare conditions.
A testament to the quality of the company’s research is the fact that when a client wishes to share non-proprietary findings in the medical literature or at major conferences, the company’s studies meet the corresponding peer-review standards, as the organization has confirmed more than a hundred times through its medical journal publications and conference presentations.
The Pillars of Clarity
With a mission to foster the well-being of people and organizations, Dr Gallagher and Ms. Carroll aim to bring clarity to complex decisions. Talking about their journeys in the field of pharmaceutical research, Ms. Carroll said she started off with her master’s thesis at Indiana University, titled “Orphan Drugs, Orphan Patients.” This journey continued in 2007 when Ms. Carroll joined the Clarity team.
After assisting with the management of fieldwork on several large pharmaceutical market research projects, she progressed to interpreting study data collected, study design, and writing study reports. In 2010, she began directing several studies before becoming Managing Director of all studies in 2012. After serving as Managing Director for a decade, Ms. Carroll acquired the company from Dr Gallagher, who remains as Chief Scientist and Director of Analytics.
Though she did not realize it at the time, she was acquiring management, writing and research skills that also are vital to owning and managing a successful pharmaceutical market research company through her undergraduate and graduate degrees in journalism and later experiences as an editor at major national and regional publications.
When Dr Gallagher founded the organization, one of the first questions confronting him was, “How do you get study-target physicians to participate in a pharmaceutical market research study?” The answer to this question was particularly important, he said in a recent interview, because non-participation bias can be another silent killer of research validity. So, Dr Gallagher decided to do a little survey to find out. He started calling former physician students of his who were now treating patients.
He first asked if each physician would participate in a brief market research study that a pharmaceutical company was sponsoring. They all said that they did not have time for such a study. He then asked, if a modest honorarium were offered for their participation, would they do so? Each one said no. They all said, in effect, that they were too busy to participate in a market research study even if an honorarium were offered.
It kept Dr Gallagher wondering what it would take to get them to participate. All but one said that they would take time to participate in such a study if they could learn something from doing so. The answer was given by a former student who was a fellow in pediatric neurology when Dr Gallagher taught him and characterizes the answers given by all the other former students the scientist called. Dr Gallagher said the physician told him, “I am always interested in what others in my specialty are doing, and I would tend to participate if I knew that I would learn something that might help me in my practice.”
Dr Gallagher said the next step was to explore options for providing study-participating physicians with feedback or information that they would value without compromising proprietary information that a client would not want to share. He found that most prospective pharmaceutical clients with whom he spoke agreed that it would be desirable to find a way to share at least some helpful information with study-participating physicians. This has led to the writing and publication of many medical journal articles and medical presentations as part of Clarity’s offered services to clients.
Distinguished and Paramount Services
When talking about the services provided by Clarity Pharma Research® LLC, Ms. Carroll said, “We are totally devoted to providing research results that accurately represent the universe of target physicians and patients that we sample, whether national or multi-national.”
For a market research survey to accurately mirror its study universe, each participant’s probability of study selection must be known and study findings weighted accordingly to accurately reflect that individual’s relative contribution to study results, she said. Clarity is the only pharmaceutical market research company that consistently provides the degree of scientific rigor required to accomplish this challenging task.
According to Ms. Carroll, any pharmaceutical company should be able to ask a current survey research supplier to select a few deidentified, anonymized patients from a recent study and show that each one’s probability of selection was used to ensure that the patient’s responses were not over- or under-represented in the study findings. She further asserted, “We can do this for all of our survey sample-based studies and provide the corresponding documentation necessary to meet peer-review journal standards when a client desires publication on non-proprietary results.”
She also noted that the unseen elephant in the room, i.e., ubiquitous unrepresentative study samples, was highlighted by Dr Gallagher in his address to several hundred market researchers at the European Pharmaceutical Market Research Association Annual Conference in London during 2013 as he pantomimed leading an elephant into the room through an outside door.
The organization also stands out from other firms in this space by avoiding or minimizing another potentially validity-killing flaw in survey-based observational studies: non-participation bias. Dr Gallagher pointed out earlier that he finds patient-care physicians are much more likely to participate in studies from which they might learn something of value for their respective practices.
In many cases, a client intends to share information from the company’s studies through presentations at medical conferences, publications in medical journals or marketing materials, and through detailing. The organization then lets potential study participants know this during their decision-to-participate process. Most of the company’s studies are double-blinded, meaning that neither the client nor the participating physician knows the other’s identity, further minimizing survey bias.
Fostering Clarity and Understanding
Understanding and helping satisfy client business needs are the company’s underlying motivations. It is a team of committed practitioners of the adage: “If you want to be heard, you have to listen,” Ms. Carroll said. This often requires helping clients prioritize their needs and research expectations. For example, the company has developed a scale to help clients do this, which goes from “absolutely essential to meeting study objectives” to “nice to have if you had the time and money.”
Performing an Optimal Role
Clarity Pharma Research® LLC is proud of playing a key role in the success of its clients, big and small. The company has helped many smaller companies optimize their limited resources. These efforts include start-ups still in clinical-phase development, companies it has helped through devising a new and cost-effective epidemiological methodology that answers the questions investors ask first: How many?
Addressing budding entrepreneurs who wish to venture into the healthcare industry, Ms. Carroll advised, “Like many, I believe that you have to develop the right product or service at just the right time and then work relentlessly with determination.”
Further, she mentioned Dr Gallagher’s presentations at medical and drug development conferences and quoted him as saying, “Opportunities in the scientific research industry, particularly healthcare and medicine, are beyond snail pace but are about to blast into outer space.”
The Future Roadmap
While addressing the question of scaling Clarity Pharma Research® LLC’s services, Ms. Carroll said, “We are excited about the exploding opportunities in our business space, and we are developing and continually revising our plans to capitalize on the changing and increasingly favorable landscape.” She also said the company is planning to continue focusing much of its efforts on rare conditions and various types of cancer. The organization is enhancing its sales structure to identify and directly reach key decision-makers in the research buying process through various social media.
Continued sharing of non-proprietary study results in the scientific literature and at medical or drug development conference presentations in collaboration with clients, particularly keynote engagements, will become even more vigorous. For example, the company will continue to share Dr Gallagher’s and Ms. Carroll’s presentations at various medical and drug discovery conferences around the world.
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