Clinical Pharmacy Articles

The independent review of imaging and clinical data in oncology clinical trials is becoming increasingly important in supporting trial outcomes. The key to designing a successful independent review process centers on prospectively defining the methodology for the review.

Early in the development of an independent review process, several key documents are generated and signed off as agreements between a sponsor and imaging core lab. These documents include a project plan, Independent Review Charter, and the Investigator Site Manual.

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In late February, the European Union announced it was launching a review of its rules on pharma-covigilance. It is not surprising that the EU should decide a review of pharmacovigilance is necessary. This is a constantly evolving discipline requiring constant alertness to how well it is meeting the objectives set for it.

What is surprising is the way that the EU chose to justify it in the formal announcement. In a statement entitled "Strengthening Medicines Safety Monitoring," it said: "A public consultation shows that the current EU system of medicines safety monitoring (pharmacovigilance) needs rationalization and strengthening."

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The medical science liaison position was created almost 40 years ago, and some of us may think our industry has progressed with the value proposition of this continually evolving role. However, considering the many challenges of cross-functional collaboration between medical science liaisons and other pharmaceutical functions, we have a long way to go toward building a collaborative environment where teamwork does not clash with compliance. The relationship between field sales forces and field MSL forces is a particularly touchy subject. In some cases, "joint calls," "gaining physician access" and "returns on investment" have become dirty words when used in the context of a sales representative-MSL relationship.

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The rep's role in patient adherence

Jul 1, 2005
By: Jane Y. Chin
Pharmaceutical Representative

Former Surgeon General C. Everett Koop said it best: "Drugs don't work if people don't take them." Patient compliance, also known as patient adherence, is defined by the World Health Organization as "the extent to which a person's behavior -- taking medication, following a diet, and/or executing lifestyle changes -- corresponds with agreed recommendations from a healthcare provider." Noncompliance is a problem that crosses socioeconomic boundaries and can have serious consequences for patients.

On a short clinical call, a sales representative will have less than two minutes of clinical dialogue with the physician. This presents a challenging situation when a sales representative goes into a call with a predetermined clinical message. One may assume that short clinical calls are easier to prepare than that rare 15-minute appointment the representative may have with a doctor. The opposite is, in fact, true: The shorter the clinical call, the more science you need to know and the better-trained you must be at identifying exactly what you need to deliver and how you should deliver it.

Many types of drug interactions can occur within the human body. Having a good working knowledge of this complex subject represents a huge opportunity for pharmaceutical representatives both to educate their customers and to better present their products.

A drug interaction can be defined as an increase or decrease in the available amount -- and therefore the effect -- of a medication caused by another medication, food or chemical that is simultaneously present in the body.

Sites of interaction

There are four main sites of interaction in the body.

The Clinical Side: Don't go DEAF on a call

Handling study objections  Part 1

Oct 1, 2005
By: Jane Y. Chin
Pharmaceutical Representative

Trainers have told me that teaching sales representatives how to do a "clinical sell" remains their top priority. A critical part of teaching this is helping representatives communicate clinical data. In my last column, I suggested that on a short clinical call, representatives should cut the canned speeches, pick pertinent points and rank research results.

Representatives who execute these suggestions may soon be rewarded with a physician's objections to the clinical study they've presented. I say "reward" because when you engage physicians in a meaningful dialogue, an objection gives you more information on the factors they consider when making decisions than enthusiastic head-nodding (which may just mean they want you out of their office as soon as possible).

The Clinical Side: Genetics and details

Educating doctors on new innovations

Nov 1, 2005
By: Neil Berliner
Pharmaceutical Representative

Knowledge of the recent breakthroughs in our understanding of human genetics will be an increasingly valuable resource to provide to your physicians. This exciting bank of information is growing practically from week to week, and it has direct relevance to the medications that are currently available or coming out very soon.

What to learn

The Clinical Side: Assumptions and false comparisons

Handling study objections -- Part 2

Dec 1, 2005
By: Jane Y. Chin
Pharmaceutical Representative

In the October issue of Pharmaceutical Representative, I presented (using the acronym DEAF) two of the four actions sales representatives should avoid when discussing clinical data with physicians: defending the study and extrapolating from the study. In this month's column, I will discuss the final two actions: making assumptions and drawing false comparisons.

The trouble with assumptions

Some assumptions can get you into trouble, especially assumptions about what the physician wants to know when you are communicating clinical information. Here is one example of what I mean:

Doctor: So, what's new?

Whether you are a specialty representative in a primary care field or you're in a niche specialty pharmaceutical field, you are probably focusing your time on the specialists in your area. Specialists are protocol-driven physicians; they are usually at the cutting edge of their therapeutic area and treat "niche" patient populations or rare diseases. At the specialist level, medicine has become as much an art as a science. Dr. Clarence Foster, the director of kidney and pancreas transplant surgery at the University of California in Irvine, is a surgeon who is interested in knowing "who is raising the bar in transplant." For Foster, this may mean steroid-sparing procedures or working with living donors or with kidneys from 60-year-old donors -- in other words, highly experimental approaches to treating a disease.