Clinical Trials—The New Way Forward

July 14, 2011 · Leave a comment

Industry Insights from Paul Meade, M. Sc, MPH

A recent article in the Wall Street Journal announced that Pfizer is conducting a clinical trial in which patients are able to use their computers and smartphones to enter information about the study, rather then spend time visiting a clinic. It was only a matter of time before clinical trials entered the social media era!

Actually, this approach makes a lot of sense, not just for the investigator, but especially for the patient. The patient is recruited over the Internet, enrolls electronically, receives laboratory tests in the mail along with test drugs, and tracks responses through an application on his or her computer or smartphone. Having participated in a clinical study before where I had to repeatedly return to the clinic, keep a paper log of reactions, bring in my responses to the study site, and answer weekly phone calls from the study nurse, I can say wholeheartedly that it was a big inconvenience. And all of that grief for the incredible reimbursement of $60!

We live in an age of instant and ubiquitous communication. I am never very far or long away from a business-related e-mail, even when I am on vacation. In fact, this instant communication has really changed the face of vacations for most people, but that is another subject ... read more »


Clinical Trial Ethics

July 7, 2011 · 2 comments

Industry Insights from Paul Meade, M. Sc, MPH

According to an article published in the Archives of Internal Medicine, Dr Joseph Ross claimed a study conducted by Parke-Davis, before it was acquired by Pfizer, using gabapentin (Neurontin), as the drug under investigation, appeared to be a “seeding” trial. And while the author states that seeding trials are not illegal, he states that they are unethical. There are really two separate issues at stake here:  first, what is really an unethical trial, and second, what is really a “seeding” trial?

About 25 years ago, when a pharmaceutical company launched a new drug and wanted to get as many physicians as possible to have some experience in using this drug for appropriate patients, they would provide samples packaged in a box to resemble supplies you might receive if you were a clinical investigator. There would be cards to report on one’s experience with the new drug, such as efficacy and side effects. But these sample cards were rarely collected and reported back to the head office. The goal was really to have physicians become familiar with this new drug, and for their own information record some information. These were not formal clinical trials, not required by the regulatory authorities, and did not need the scrutiny of an Institutional Review Board. These ersatz trials became ... read more »


Successful Product Launches with the Right Thought Leaders

June 30, 2010 · Leave a comment

Industry Insights from Paul Meade, M. Sc, MPH

When a biopharmaceutical company introduces a new medicine to the market, it comes after years of research, years of clinical development, and some times even years of regulatory review. With the patent ticking away from the early days of discovery, recovering the cost of such an investment in time and money requires a rapid and successful product launch. Achieving rapid success requires careful planning and a tremendous amount of valuable advice. This sage advice usually comes from respected thought leaders with years of experience in their respective therapeutic areas of expertise.

>From the early discovery phase, key opinion leaders help guide a company’s basic research to ensure unmet medical needs are met in a meaningful and cost-effective way. After moving beyond the proof-of-concept stage and into clinical development, other thought leaders play a critical role in assisting with the design of clinical trials that will be implemented through a network of investigators. Throughout the clinical development phases, thought leaders help guide a company with the most important messages other physicians will hear about the strengths and weaknesses of such a new medicine. And finally, as this new product enters the marketplace and is prescribed by the medical community, thought leaders play an important role ... read more »


Thought Leader Select delivers KOL identification research to five leading pharma companies in the U.S. and Canada

April 14, 2010 · Leave a comment

April 15, 2010 (CHAPEL HILL, NC)—Thought Leader Select, a North Carolina-based firm dedicated to delivering solutions for key opinion leader (KOL) management for the biopharmaceutical industry, has announced the delivery of KOL identification projects for five leading North American pharmaceutical companies during the first quarter of 2010.

Five of the world’s largest pharmaceutical concerns contracted with Thought Leader Select in late 2009 to take advantage of the firm’s industry-leading deep profiling methodology for researching the skills and experiences of physician key opinion leaders across multiple therapeutic areas and disease states.  Each company had specialized needs for initiation and redevelopment of their respective rosters of key opinion leaders to assist them in a variety of deployment needs.

Thought Leader Select assisted a Canadian firm with the identification of physician key opinion leaders who specialize in influenza vaccines. The company plans to build a firm roster of KOLs in advance of a new influenza vaccine product launch.

A U.S. firm contracted Thought Leader Select to identify nurse practitioners and physician assistants, also known as non-traditional KOLs, in the therapeutic areas of gastroenterology, hepatology, and HIV/AIDS treatment, in order to better understand patient needs in these areas and gain scientific and clinical insights for new compounds.

Thought Leader Select identified Canadian physician key opinion leaders for another Canadian company, with emphasis on KOLs who specialize in heart ... read more »


The Trifecta of Mutually-Beneficial Relationships: KOLs, Pharma, and Patients—Part Five

March 30, 2010 · Leave a comment

Over the past several weeks, we’ve talked about how collaborations among key opinion leaders, clinical investigators and pharmaceutical and biotechnology companies benefit the companies, the KOLs or clinical investigators, and patients. The foundation of these mutually-beneficial collaborations is the objective, methodical approach to understanding KOLs’ and clinical investigators’ skills and experiences.

Many methods promise to illuminate the strengths of KOLs and investigators; however, key hallmarks of the best approaches include the following attributes:
· An objective review of accomplishments and areas of focus, including, but not limited to, a KOL’s/clinical investigator’s involvement in patient care, academic pursuits, medical publishing, basic and clinical investigation and areas of expertise.
· A keen understanding of the KOL’s/clinical investigator’s goals for his or her practice as well as his or her desires for partnering with industry.
· Commitment to involving KOLs and clinical investigators in activities that closely match their skills, experiences, goals and desires.

Thought Leader Select’s methodology, known as “deep profiling,” coupled with our leadership team’s 70+ years of combined experience working in and with the pharmaceutical and biotechnology industries has enabled our company to build an impressive record of success with assisting pharma with KOL engagement and deployment strategies. Our work results in more mutually-beneficial collaborations, for KOLs, pharma, ... read more »


The Trifecta of Mutually-Beneficial Relationships: KOLs, Pharma, and Patients—Part Four

March 25, 2010 · Leave a comment

Pharmaceutical & Biotechnology Companies Provide Early Knowledge-building Opportunities for KOLs and Clinical Investigators

Understanding the value that key opinion leaders provide pharmaceutical and biotechnology companies is clear, but how do companies benefit thought leaders and clinical investigators? By definition, KOLs are physicians, scientists and academics who devote time to studying and advancing their craft. Often, these academic pursuits are broadened by involvement in early-stage advisory board meetings and clinical investigations.

In the early stage of molecule development, pharmaceutical and biotechnology companies rely on KOLs to help shape how a new compound will be used in patients, to design clinical studies, and to determine pricing. Simultaneously, thought leaders gain early knowledge about new ways of treating patients with specific diseases and illnesses. They also learn about new treatment breakthroughs and therapies that provide greater value for patients.

Clinical investigators who participate in early-Phase II investigations are helping companies determine correct dosing, timing and other safety issues. At the same time, they too have a first look at new therapies as well as the opportunity to shape future treatment guidelines. Additionally, these investigators often present new clinical data to other scientists and physicians, which reveal possibilities for future research and investigation.
Opportunities for ... read more »


Industry Contraction Spurs New Partnership Opportunities

February 25, 2010 · Leave a comment

According to a February 2010 article in, pharmaceutical companies will continue to outsource more of their business to single-service providers. To capture more business, CROs will merge or focus on niche opportunities.

Thought Leader Select, a research firm providing sophisticated KOL deployment strategies to the pharma and biotech industries, has developed a unique opportunity to provide pharma companies – through their outsourced partnerships with CROs and other research outfits – predictive models for selecting clinical investigators. These models, known as Clinical Investigator Success Plans, match the skills, experiences, and preferences of clinical investigators with companies’ trial protocols to improve the success rates of their studies.

Companies can often trace clinical trial pitfalls to their investigators’ abilities to recruit the right patients in a timely fashion, according to Paul Meade, President of Thought Leader Select. “When companies understand the trial environments that best match the clinical investigator’s strengths, they will ultimately avoid setbacks that delay trials from meeting critical endpoints and also avoid over-spending on clinical research,” said Meade, a 25-year veteran of the pharmaceutical industry.

Read the full article here.

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