Clinical Trials Development

One of the biggest challenges for delivering a successful clinical study is to identify the patient segment that is closely aligned with the likely label for your innovative drug or technology in development. This is important for selecting the clinical sites needed that can deliver the required number of patients at the agreed recruitment rate.

This can be a challenge if the criteria of the sub-populations are very narrow or there is several companies conducting studies for similar treatments.  A good understand of where these potential patients are located can be a significant advantage and crucial to a Clinical Research organisation (CRO) or pharmaceutical company who is in competition with other companies for patients with the same profile.

With the Epiomic™ database, you will be able to determine quickly the patient segment, based on important attributes, age, gender or co-morbidities linked to the treatment, for a particular disease. 

With a 25 year outlook, you will be able to determine the total potential patient pools for the disease over the length of the study. Using the same profile, you can then look between the 6 major markets to see which country can yield the most patients which will inform the location and number of clinical sites required.

Nephropathy Example

Situation

A company is developing a pre-clinical product that has the potential to ameliorate (and potentially reverse) kidney damage. The utility has only been defined by the science only so far as ‘patients with nephropathy’.

There is a need to define a trial population for the initial studies, determine rates of progression/mortality and downstream events so the product can achieve a viable market price.

Solution

Generating patient segment/population: 

Drawing from published literature, databases & registries, patient segments are defined for:

  1. Microalbuminuria
  2. Macroalbuminuria
  3. Chronic kidney stage III (eGFR<70)
  4. Chronic Kidney stage IV
  5. Chronic Kidney stage V/end –stage renal failure
  6. Patients receiving renal replacement therapy
  • Dialysis
  • Transplant

Key Outputs

Since the analysis can be run on any of the target segments, it is possible to determine the optimal patient segment for the trial (e.g. Segment most likely to yield a positive Health Economic outcome because of a higher downstream cost). In this case, stage IV CKD due to high mortality but also high cost associated with renal replacement therapies. Small benefits here have high impact on cost saved.

Since patient segments are quantified at a total country level, better estimates on patient recruitment rate and overall clinical trial time can be determined with a level of confidence. This can reduce the clinical trial costs and the time.

Key advantages to having Epiomic database information:

1. The ability to determine the likely recruitment rate based on the regional and overall population impacted by the condition
2. Potentially identify regional patient ‘hot spots’ and correlate them with the clinical centres of excellence where the trials can be conducted and potentially generate a higher recruitment rate
3. To identify a patient segment that could generate a shorter end-point for the study reducing the overall cost and length of trial
4. The capacity to feed into a Health Economic Outcomes Research (HEOR) study where you are trying to identify required thresholds, regulatory hurdles and treatment gold standards.