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 »

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Fast Facts from Thought Leader Select—Trends in HIV Reimbursement and Regulatory Involvement

September 14, 2010 · Leave a comment

Health care systems across the globe rely on the advice and counsel of health care professionals (HCPs) when making decisions on new therapies to approve appropriate levels of reimbursement for various pharmaceutical products. These regulatory and reimbursement advisers have various backgrounds, including health outcomes and economics, clinical pharmacy and medicine.

Within each medical discipline, certain physicians regularly advise government regulatory agencies and public and private insurers on which therapies meet unmet medical demands and have the lowest risk for adverse reactions as well as provide input into reimbursement considerations. Each key opinion leader (KOL) assessment conducted by Thought Leader Select includes an examination of KOL engagement in regulatory and reimbursement activities.

In an ongoing assessment of nearly more than 150 HIV key opinion leaders across the globe, Thought Leader Select has analyzed their participation in regulatory and reimbursement activities. Using keywords to link these KOLs with such activities, Thought Leader Select found that 33% of physicians regularly provide input into regulatory and reimbursement decisions. The 53 KOLs with regulatory and reimbursement involvement are split nearly in half according to their participation in general or HIV-related activities (see Chart 1). However, the majority of Thought Leaders studied are involved in public reimbursement efforts (see Chart 2). Common regulatory and reimbursement groups among studied ... read more »

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Fast Facts from Thought Leader Select—Trends in Diabetes Advocacy Involvement

August 2, 2010 · 2 comments

Key opinion leaders (KOLs) are health care leaders who make a high-impact footprint while advancing medical science. Thought Leader Select specializes in delivering objective, validated data on the skills and experiences of KOLs, so that pharmaceutical companies can seek their advice and guidance in the development of new medicines.

Over the past several years, Thought Leader Select has studied physician key opinion leaders who treat diabetes and analyzed their involvement in many areas, including clinical research, treatment guidelines involvement, publishing, reimbursement involvement and participation in advocacy efforts. In a recent assessment of nearly 500 diabetes KOLs across the United States, Thought Leader Select examined their participation in patient advocacy activities. Using keywords to link these KOLs with such activities, Thought Leader Select found that 62% of physicians regularly take part in patient advocacy efforts, such as participation in advocacy organizations, patient education or legislative efforts (see Chart 1).

Of the 301 KOLs with advocacy involvement, most take part in five or fewer activities, while only 3% of them boast 10 or more advocacy activities and/or awards. In addition to activities through the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) – especially the American College of Endocrinology’s Power of Prevention (POP) program – top advocacy initiatives and organizations include:

• Taking ... read more »

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Medical Experts Drive Approval Process, Ensure Drug Safety

June 1, 2010 · Leave a comment

In a recent post on Pharmalot, the pharmaceutical industry blog highlighted a recent survey that gauged American opinions on the speed and safety of the process for developing new medicines.  The survey, conducted by Eli Lilly and ResearchAmerica, measured a number of opinions Americans hold regarding the pharmaceutical industry and the FDA itself.

While over 70 per cent of the respondents trust the FDA approval process for new drugs, more than half say the process should be faster.  The most stunning numbers in the survey come from the questions regarding industry collaborations with universities and the government. Ninety-four  per cent of the respondents said that pharmaceutical companies, universities, and the government should work together to develop new medicines more quickly and safely, and 88 per cent said that it was a good idea for drug companies to collaborate with hospitals, universities, and other health institutions.

The Lilly/Research America survey gives even more weight, the weight of public opinion,that the pharmaceutical industry must continue to increase its collaborations with medical experts to ensure that new medicines are delivered safely and in a timely fashion.  Working with the right experts at the right points of development can save millions of dollars in development costs, and, more importantly, save more lives.

At Thought Leader Select, the collaborative synergy of the pharmaceutical industry and medical experts ... read more »

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