http://www.phrma.org/publications/publications/2004-06-30.1035.pdf (excerpts)
This document is effective from October 1, 2002.

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents
research-based pharmaceutical
and biotechnology companies. Our members discover, develop, manufacture and market
new medicines and vaccines
to enable patients to live longer and healthier lives.
The development of new therapies to treat disease and improve quality of life is a
long and complex process. A critical part of that process is clinical research, the
study of a pharmaceutical product in humans (research participants).

We conduct clinical trials in accordance with applicable laws and regulations, as
well as locally recognized good clinical practice, wherever in the world clinical
trials are undertaken. When conducting multinational, multi-site trials, in both the
industrialized and developing world, we follow standards based on the Guideline for
Good Clinical
Practice of the International Conference on Harmonization.

c. Training of Investigators. Investigators and their staff are trained on the
clinical trial protocol, pharmaceutical product,
and procedural issues associated with the conduct of the particular clinical trial.

d. IRB/EC Review. Prior to commencement, each clinical trial is reviewed by an
IRB/EC that has independent decisionmaking
authority, and has the responsibility and authority to protect research
participants.

? The IRB/EC has the right to disapprove, require changes, or approve the clinical
trial before any participants are enrolled
at the institution or investigative site for which it has responsibility.
? The IRB/EC is provided relevant information from prior studies, the clinical trial
protocol, and any materials
developed to inform potential participants about the proposed research.

e. Informed Consent. We require that clinical investigators obtain and document
informed consent, freely given without
coercion, from all potential research participants.

f. Clinical Trial Monitoring. Trials are monitored using appropriately trained and
qualified individuals. The sponsor will
have procedures for these individuals to report on the progress of the trial
including possible scientific misconduct.
? These individuals verify compliance with good clinical practices, including (but
not limited to) adherence to the
clinical trial protocol, enrollment of appropriate research participants, and the
accuracy and complete reporting of
clinical trial data.
? If a sponsor learns that a clinical investigator is significantly deficient in any
area, it will either work with the
investigator to obtain compliance or discontinue the investigator’s participation in
the study, and notify the relevant
authorities as required.

h. Privacy and Confidentiality of Medical Information. Sponsors respect the privacy
rights of research participants and safeguard the confidentiality of their medical
information in accordance with all applicable laws and regulations.

Clinical investigators and institutions should not be compensated in company stock
or stock options for work performed on individual clinical trials.

Availability of clinical trial results in a timely manner is often critical to
communicate important new information
to the medical profession, patients and the public.

We design and conduct clinical trials in an ethical and scientifically rigorous
manner to determine the benefits, risks, and value of pharmaceutical products. As
sponsors, we are responsible for receipt and verification of data from all research
sites for the studies we conduct; we ensure the accuracy and integrity of the entire
study database, which is owned by the sponsor.
a. Communication of Study Results. Clinical trials may involve already marketed
products and/or investigational
products. We commit to timely communication of meaningful results of controlled
clinical trials of marketed products or investigational products that are approved
for marketing, regardless of outcome. Communication includes publication of a paper
in a peer-reviewed medical journal, abstract submission with a poster or oral
presentation at a scientific meeting, or making results public by some other means.

Some studies that sponsors conduct are of an exploratory nature (early-phase or
post-marketing). These are
often highly proprietary to the sponsoring company,and due to their limited
statistical power, serve primarily
to generate hypotheses for possible future trials.

Sponsors do not commit to publish the results of every exploratory study performed,
or to make the designs of
clinical trial protocols available publicly at inception, as in a clinical trials
registry. If the information from an
exploratory study is felt to be of significant medical importance, sponsors should
work with the investigators
to submit the data for publication.

In all cases, the study results should be reported in an objective, accurate,
balanced and complete manner, with a discussion of the strengths and limitations of
the study.

c. Related Publications. For a multi-site clinical trial, analyses based on
single-site data usually have significant statistical
limitations, and frequently do not provide meaningful information for health care
professionals or patients and therefore
may not be supported by sponsors. Such reports should not precede and should always
reference the primary presentation or
paper of the entire study.

d. Investigator Access to Data and Review of Results.

As owners of the study database, sponsors have discretion to determine who will have
access to the database.
Generally, study databases are only made available to regulatory authorities.
Individual investigators in multi-site clinical
trials will have their own research participants’ data, and will be provided the
randomization code after conclusion of the trial.
Sponsors will make a summary of the study results available to the investigators. In
addition any investigator who participated in the conduct of a multi-site clinical
trial will be able to review relevant statistical tables, figures, and reports for
the entire study at the sponsor’s facilities, or other mutually agreeable location.

g. Provision of Clinical Trial Protocol for Journal Review.
If requested by a medical journal when reviewing a submitted manuscript for
publication, the clinical trial sponsor
will provide a synopsis of the clinical trial protocol and/or pre-specified plan for
data analysis with the understanding
that such documents are confidential and should be returned to the sponsor.

Are there ever times when it would not be appropriate to publish results from a
hypothesis-testing clinical trial?

There are some situations where publication of results from a hypothesis-testing
clinical trial would not be appropriate, and
which have nothing to do with whether the study is “positive” or “negative” with
regard to the performance of the sponsor’s product.

Examples are provided below.
1. Studies occur in which the data are found to be invalid. There is an implicit
assumption that the data collected in a clinical trial will be “valid,” but
sometimes this turns out not to be the case.

For example, there might be an erroneous laboratory assay or equipment malfunction,
or disruption of study sample shipment
rendering test data using these samples unreliable. Publication of results based on
invalid data is inappropriate as
it could adversely affect physician and patient decisions (invalid results could
appear positive for the product or intervention, for
example). However, sponsors want to be clear that valid results which do not support
the hypothesis being tested, or which are
contrary to the sponsor’s preferred outcome, should be published, because they are
meaningful. In other words, negative
results do not mean invalid results.

2. A study may not answer the question(s) for which it was designed.
For instance, a study may be ended prematurely and the amount of data gathered is
insufficient to draw conclusions
(e.g., when preclinical data become available after a trial has been initiated and
the sponsor must terminate the trial well
before its planned conclusion). This is an example of a “failed” clinical trial.
Frequently these types of studies are not accepted
for publication by medical journal editors, but the sponsor should review the data
with the study investigators to determine
whether they warrant submission for publication or are otherwise meaningful.

The Principles refer to “communication” of trial results, either by publication in a
peer-reviewed journal, presentation
at a medical meeting, or making results public by some other means.

Why don’t the Principles just say that sponsors commit to publish all clinical trial
results in
peer-reviewed medical journals?
While publication of study results in a peer-reviewed medical journal (such as the
New England Jounal of Medicine, JAMA or Lancet) is the preferred method of
communication, this is not always possible.
These journals are independent and, with the assistance of recognized experts in the
relevant fields (peer reviewers), make their own determination about what to
publish, and when. Some medical journals accept less than 10% of the manuscripts
submitted to them.
Manuscripts may be rejected for a variety of reasons, including lack of interest,
lack of novelty, or inconclusive results.
Consequently, the Principles provide some alternatives for the communication of
clinical trial results. For instance, clinical trial
data can be made public through presentation of the results at a professional
scientific meeting, which involves oral presentations

During the clinical trial, sponsors are obligated to record and evaluate all safety
information they receive from investigators or from any other source. If a sponsor
receives adverse event information that suggests a potential significant safety
concern for the sponsored trial, the sponsor must notify all investigators in the
trial and the health authorities in an expedited fashion. For example, in the U.S.
and some other countries, sponsors must report unexpected serious adverse events
within 15 days, and life-threatening adverse events within 7 days.

Most Phase III and adjuvant trials are randomized.
You don't get to choose.
http://www.cancerguide.org/trials_phase3.htm
J

That's entirely wrong.
The whole point of a placebo controlled trial is that it isn't known whether
the new therapy is better (or worse) than placebo.