Clinical Research Trials

Clinical Research Trials

Clinical Research Trials (CRT) provide a rewarding opportunity for physicians to participate in medical
science and become thought leaders among their peers. Participation in research trials enables
physicians to provide innovative treatment options for their patients, while adding to their expertise.

Conducting clinical trials educates physicians on leading edge treatments, medications and devices while
providing an advantage to their patients. This also means patients can take advantage of treatments
that may not be found elsewhere, enhancing patient loyalty and attracting new patients.

Currently, only about 15% of physicians participate in research trials as they are unaware of the benefits
or how to access trial opportunities available. Partnering with a Site Management Organization (SMO)
gives physicians access to hundreds of different trials that are being conducted at any given time.

Clinical trials provide an additional revenue for physicians with the average physician generating
$200,000 or more per year for participating in just 2 trials.

Services provided by the SMO are all encompassing, helping to minimize any additional burden that
running additional programs in an office could bring.

Physician and Practice Benefits

  • Recognition as a thought leader
  • Grow your practice with new patients
  • Inside track to cutting edge medicine
  • Reduce dependency on health insurance and reduce administrative burden
  • Free advertising for your practice
  • Get paid directly by the pharmaceutical company providing a new revenue stream
  • Full program support for CRT integration

Patient Benefits

  • Enables providers to offer alternate therapies not yet freely available
  • Enhances physician expertise in managing patient care
  • Remuneration to the patient for participation
  • Access first to breakthrough treatments

How Does It Work?

doc and patient

Clinical trials have long been needed for assessment of efficacy and side effects of medications. Trials
occur in 4 different phases:

Phase 1) First in Human (FIH). This phase begins to collect safety data and is done on a small number of
healthy patients.

Phase 2) Proof of Concept. This is where the drug is studied to see if it works. Researchers will still be
measuring for safety, but their prime concern is toward efficacy. Patients will usually have a disease or
condition that the drug is being tested to treat. This phase can last for a few weeks up to 2 years.

Phase 3) Tests for efficacy on a larger scale. The target patients will have the specific disease or
condition the drug is being tested for and will require anywhere from 3,000 to 10,000 patients over a 1
to 5 year time span.

Phase 4) Post marketing study. This is where the drug has been released to market and has been FDA
approved. This phase of testing is optional for drug companies and is typically done for further
marketing, though in rare instances, the FDA will request Phase 4 testing.

Most opportunities for physician practice clinical trials will lie in Phase 3.

Opportunities exist for physicians of suitable practice size to participate as a Clinical Trial Investigator.
The physician can apply and complete appropriate paperwork to register their interest and once
approved will be offered ongoing opportunities for a range of trials. Typically, physicians are encouraged
to apply for multiple trials to increase their likelihood for acceptance.

Trials available are varied and can include behavioral, cancer, Parkinson’s, allergy, gastroenterology,
renal, heart failure, endocrinology and more. There is something for any practice specialty.

How Do I Get Started?

There is no cost to getting started.

The physician must submit a resume, the partner agreement and a summary of investigator data.

Once accepted, the investigating physician will designate a practice Point of Contact. Selecting the right
person in the practice to do this is critical to the success of the program.

The practice will then begin to receive emails on open and available studies that pertain to the practice
specialty.

Submit for as many studies as possible to get the first study ASAP.

Your representative will follow up weekly with the office to check on progress and assist in securing a
trial.

Your SMO will provide assistance in patient recruitment and enrollment.