Work hard to avoid clinical trial protocol amendments as they consume a great deal more resource than one imagines in staff time to prepare, review (internally and by IRBs and FDA and sometimes by the investigators), and implementation. Some vendors offer systems to minimize the number of amendments a company will need by subjecting protocols to multiple internal checks of consistency and comparisons with other protocols that have been conducted.

Mega trials require shorter protocols, shorter case report forms and less monitoring. Companies often monitor these (and other) trials more than needed.

Reimbursing for patient travel, babysitting, meals, parking or transportation and other incidentals is acceptable in most, but not all, countries for all patients in clinical trials.

Double blinding a clinical trial (i.e., the investigator and patient) is rarely sufficient today to maintain a sufficient blind. It is also necessary in most cases of randomized controlled trials to blind the clinical monitors, the sponsor's statisticians (except for one), and the staff who are conducting special procedures (e.g., EKGs, eye exams, MRIs).

Single-blind trials are virtually equivalent to open-label trials.

Double-blind trials vary along an entire spectrum from those that are truly double- blind to those that have become totally un-blinded. It is often imprtant to determine where on that spectrum a specific trial is located. This can often be determined by questioning the investigator and patients about the treatment they believe was given and the reasons for their choice. Surprises often occur in reviewing these data.

Open-label clinical trials often mislead a company as the data obtained have a much greater likelihood of being positive than if the same trial was done in a double- blind manner. This may lead to a company wasting years of effort and millions of their money until they recognize that the drug really did not demonstrate efficay in a true double-blind study.

About 80% of open-label trials are positive whereas only 20% of double-blind trials show positive results when the exact same question is evaluated in an almost identical study.

The ability to pose the most clear, most focused and appropriate research, marketing, business or other questions to address is an extremely valuable skill for everyone to develop. Those who can do this well should become known within and outside their organization for this skill, and their advice and input sought.

Professional talks and presentations are not like mystery novels where you build to a glorious and possibly surprise climax and conclusion. Share the conclusions up front with your audience or listeners. Tell them what you will tell them, then tell them, and then tell them what you told them.

Learn what it means to service your customers. Everyone without exception has customers (even the Chairman of the Board), so identify all of them and then listen carefully to them.

For those who use consultants, even on an occasional basis, identify a group of core consultants in each area and function where you may need their assistance.

There are two major ways used to discuss the overall costs of bringing a new drug to the market. First, the cost of all failures and all successes over a period of time are totalled, averaged and then presented as the cost of a single success. The other approach is to solely determine the discovery, development and other costs of only one specific drug that is brought to the market. Both ways are important to understand as each has its own specific and legitimate uses.

When words like "compliance" and "risk" are used, does everyone reading the text or listening to the presentation understand which definition is being used? These and many other words have a variety of definitions, particularly for those with different perspectives and positions.

According to regulations, new drugs do not have to be better than currently marketed drugs in their degree of safety or efficacy. However, some regulators forget this and have to be reminded. If safety or efficacy is not quite as good as a marketed drug the other component must greatly exceed current therapy for the benefit to risk ratio to be positive in comparison to currently approved therapy.