autologous blood and marrow transplantation - Blog Science ...

732 Chapter 16: Summaries
Table 2. Continued from previous page
iv) Third party payers should welcome the opportunity to fund the clinical research
to improve outcomes for their customers in this difficult situation at academic
centers focusing on this particular problem.
Group's question
3) Private sector competition: Many community physicians are now giving high dose
therapy to their patients, which reduces referrals to our transplant centers. This is espe­
cially true of patients with high DFS probability, e.g., adjuvant breast cancer patients.
Should we do anything about this decentralization of medical technology?
Author's response
NO! Translation is a goal; decentralization is dissemination.
i) In the course of performing their assigned duties, academic physicians
a) train young doctors to be at least as good clinicians as their teachers and
b) explore new ideas to improve clinical outcomes for patients in specific
circumstances all the while rendering the best clinical care they know how
for their patients. Success in academic jobs means former trainees are in the
community practicing the new state-of-the-art medicine that their teachers
have developed.
ii) In a public health sense, transfer of technology into the community is a goal and
should only result from good science demonstrating efficacy and safety as well as
masterable technology.
iii) The extent to which decentralization occurs is a fundamental measure of how
valuable clinical research is.
iv) Community physicians doing transplants should be drawn into academic center
networks to participate in clinical research and to report data on outcomes.
Group's question
4) Phase III Trials. Considering that resources are always limited and that formal proof
(level one data) requires a prospective, randomized trial, should we not devote all of our
energies to performing phase III trials?
Author's response
QUALIFIED NO! There is a time for everything.
i) Phase III trials confirm or deny the hypothesis that a new treatment plan is better
than an old treatment plan, for instance.
ii) Phase III trials require considerable time and resources to plan, draft, gain all
approvals, initiate, monitor performance, collect and validate data, evaluate and,
finally, communicate results to the clinical science arena.
iii) Phase III trials do not make new discoveries.
iv) There are times when phase III trials are not appropriate but other phase trials
are (see Tables 3 and 4).
v) Finally, there are times when well designed phase III trials asking highly relevant
clinical questions and moved along as fast as humanly possible are out-of-date by
the time their results are communicated because biotechnology growth and
development have voided the need for the answer to the question the phase III
trial posed in the first place.