Howe's Law: Every man has a scheme that will not work.
Gordon's First Law: If a research project is not worth doing at all, it is not worth doing well.
First law of evolving system dynamics: Once you open a can of worms, the only way to re-can them is to use a larger can, giving you a bigger can of worms.
Ninety-Ninety Rule of Project Scheduling: The first 90% of the job takes 90% of the time, and the last 10% takes the other 90%.
The six phases of a project are:
1. Enthusiasm
2. Disillusionment
3. Panic
4. Search for the guilty
5. Punishment of the innocent
6. Praise and honors for the non-participants
Some people react to good or bad important news by going Mmmmmmmmmm, as if they already knew this or didn't care. This can be a useful technique to learn, or a ruse that you may want to challenge.
Thursday, December 17, 2009
The concept of a product's medical value has to be carefully and creativiely built and developed. Medical value is not a simple concept and various ways of expressing this must be evaluated.
Agreements between a pharmaceutical company and an investigator have morphed over the last 35 years from being a gentlemen's agreement and a single page letter to a rigid contract geared to protecting the institution, preserving academic freedom and rights of the company.
Data from several small trials or even from case studies, can be combined in a meta-analysis to achieve a whole that is greater than the sum of its parts.
A clinical professional assigned to focus on patient retention in a clinical trial should be proactive and try to prevent issues that may lead to patient withdrawal.
Agreements between a pharmaceutical company and an investigator have morphed over the last 35 years from being a gentlemen's agreement and a single page letter to a rigid contract geared to protecting the institution, preserving academic freedom and rights of the company.
Data from several small trials or even from case studies, can be combined in a meta-analysis to achieve a whole that is greater than the sum of its parts.
A clinical professional assigned to focus on patient retention in a clinical trial should be proactive and try to prevent issues that may lead to patient withdrawal.
Thursday, December 10, 2009
One will make better decisions about a drug's development using high quality clinical data from fewer patients than by basing the decision on mediocre data from a large number of patients.
Challenge yourself and others to reduce the number of inclusion criteria, even for Phase 2 trials where you want a homogeneous population of patients.
While a statistical interpretation of clinical data is done by a statistician, the clinical interpretation of clinical data is done by a clinician. Even if a single person is trained and experienced in both fields the two processes are different.
Analyses of clinical data usually refer to statistical analyses. A clinician is important for making suggestions (to a statistician) of which analyses to conduct, both in advance of the trial being completed and after the initial analyses are completed.
Unexpected or strange interpretations should always be carefully assessed, questioned, and reassessed before they are either accepted or challenged.
Challenge yourself and others to reduce the number of inclusion criteria, even for Phase 2 trials where you want a homogeneous population of patients.
While a statistical interpretation of clinical data is done by a statistician, the clinical interpretation of clinical data is done by a clinician. Even if a single person is trained and experienced in both fields the two processes are different.
Analyses of clinical data usually refer to statistical analyses. A clinician is important for making suggestions (to a statistician) of which analyses to conduct, both in advance of the trial being completed and after the initial analyses are completed.
Unexpected or strange interpretations should always be carefully assessed, questioned, and reassessed before they are either accepted or challenged.
Tuesday, December 1, 2009
One can improve the value of a product by focusing attention on how you refer to the product you are developing. The first point is to try and find another term than "drug" to describe the product. A few of the many alternative terms are: enzyme replacement, antidote, chemopreparative regimen, essential nutrient. Note that an enzyme replacement does not have to be an enzyme. The connotations of the chosen term may facilitate interactions with regulatory agencies and eventual marketing.
The closer that community based trials can approach the actual practice of medicine, the more willing practicing phsicians will be to accept the results of the trials and apply them to their own patients.
Active drug surveillance techniques can preempt accusations by a vocal consumer activist group that a company is not acting responsibly to investigate and study an issue or problem with one of its drugs.
If more than three people have to approve routine drug development proposals the company has an important issue to investigate as it is not being efficient.
The closer that community based trials can approach the actual practice of medicine, the more willing practicing phsicians will be to accept the results of the trials and apply them to their own patients.
Active drug surveillance techniques can preempt accusations by a vocal consumer activist group that a company is not acting responsibly to investigate and study an issue or problem with one of its drugs.
If more than three people have to approve routine drug development proposals the company has an important issue to investigate as it is not being efficient.
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