| |
To design a clinical
trial for TMD, a collaborative group of individuals - albeit with
different specific roles -- must be brought together.
- The principal
investigator (PI) is the leader of such a group, and usually
is an experienced scientist who is familiar with randomized
trials and the clinical condition such as TMD.
- A quantitative
scientist, such as a biostatistician or epidemiologist is
the person to help guide the PI with the design of the trial,
especially with the key issues of how to measure the outcomes,
determine an adequate sample size, the statistical methods to
be used in the analysis, and how the data collected will be
analyzed.
- Data managers
have as their primary job ensuring the integrity of the data
that is being collected.
- The clinical
providers in the trials, usually dentists in this case,
(but also psychologists, physical therapists, dental hygienists,
etc.) are valuable in the planning stages, and can shed light
on the feasibility and implementation of the interventions that
are being considered, besides the clinical relevance of the
primary research question.
- Other personnel
may not be involved at the design stage, but will be involved
with conduct, such as patient recruitment, data entry, etc.
In Orofacial Pain Centers,
such as at the University of Washington, the orofacial pain research
group comprises multiple people with both unique and overlapping
tasks who work together as a team, including persons with dual
roles, such as PI/clinicians, epidemiologist/clinicians, clinical
managers/research hygienists. Both specificity and overlap of
skills help to minimize errors and maximize the utility of the
group.
As an illustrative
example, Table 4.1 below provides a listing of the key scientific,
clinical, and data management personnel (and, for general reference
only, the full-time equivalent personnel in each category), who
comprise the Orofacial Pain Research Group at the University of
Washington for the conduct of RCTs in TMD.
Although it is possible
for a single investigator to design, conduct, and analyze a clinical
trial, it is rarely done today because of the comparative advantage
of assembling multiple people with specialized knowledge who can
work together as a team to accomplish the overall goals of the
study. In a later section below, we return to a discussion of
pragmatic aspects of conducting a multicenter randomized control
trial.
Table
4.1 Personnel Comprising a Team for Conducting TMD
Clinical Trials Research (Illustrative
example: University of Washington Orofacial Pain Research
Group, 2002)
|
|---|
Personnel
| Extent
of Effort
(as full-time equivalents)
|
|---|
| Epidemiologist
Investigator | 1.0 |
| Biostatistician
Investigator | 0.5
- 1.0 |
| Clinical
care provider - Investigators (Oral Medicine faculty
trained as TMD specialists) | 1.5
(5 - 6 dentists) |
| Health
Services Researcher Investigator | 1.0 |
| Behavioral
Medicine Specialists Investigators (Clinical Psychologists) | 1.5
(3 - 4 psychologists) |
| Clinical
Research Manager | 1.0 |
| Data
Manager | 1.0 |
| Clinical
research support staff (Recruiting, enrolling, data
entry/cleaning, administrative) | 2.0 |
|
|