Clinical Trials Operations Planning

Clinical trials cost too much, take too long, and are too risky. They make up over half the cost of new drug development and can reach or exceed $400M. The length of time to conduct clinical trials can take as long as 4-5 years. Only about a third of drugs that enter clinical testing ever progress to large-scale phase III studies.

According to the Center for the Information & Study on Clinical Research Participation reports, nearly 75 percent of studies are delayed from a month to six months. At an estimated cost of $35,000 a day, one month trial delay equates to $1,050,000. A six-month delay means over $6M. Protocol complexity, missed enrollment targets, inefficient site-based monitoring, mid-study changes, and lack of collaborative process management are potential causes for these delays. Bottom line is, delays are extremely costly.

Solutions that can help minimize the cost, time, and risk of clinical trials are extremely valuable for improving new drug development productivity.

Technology Multipliers offers two simulation and analysis solutions to aid in clinical trial design and operations planning: 1) Clinical Trials Process Simulation (CT-PS), and 2) Clinical Trials Supply Chain Simulation (CT-SCS). The combined business value of our Clinical Trials Operations Planning solutions are:

  • Increased confidence in successful outcomes,
  • Reduced risk of poor study design due to projecting unrealistic trial completion dates, patient recruitment, site selection, and resource requirements,
  • Elimination of unnecessary delays,
  • Increased supply chain efficiency,
  • Ensuring the trials stay on track as a result of mid-study adjustments.

Clinical Trials Process Simulation (CT-PS)
Benefits:

  • accurately predict patient recruitment rates
  • optimize site selection combination
  • estimate protocol completion dates
  • forecast trial costs and FTE requirements
  • compare alternative site selection and patient recruitment scenarios
  • ongoing trial monitoring (compare actual versus projected)
  • mid-study adaptations and forecasting of future patient recruitment

Inputs:

  • Center recruitment characterization
  • Number of sites per country
  • Number of patients required
  • Site recruitment requirements
  • Fixed and variable costs
  • Forecasted trial milestones and study end date

Outputs:

  • Total estimated cost of the trial
  • Realistic estimates of milestone timelines for FSFV, LSLV, and close-out dates
  • Accurate projection of site recruitment rates

Clinical Trials Supply Chain Simulation (CT-SCS)

Certain clinical trials may benefit from the use of simulation for supply chain planning. When medications are expensive or scarce, studies contain complex stratifications, or studies are likely to change during the trial period, CT-SCS can help evaluate the supply chain strategy to minimize the time, cost, and risk.

Benefits of CT-SCS include:

  • accurately forecast clinical supply requirements,
  • determine optimal packaging configurations,
  • plan for mid-study adaptations and forecast future supply and packaging requirements,
  • evaluate productivity gains provided by technologies such as BPM (Business Process Management) or IVR (Interactive Voice Response).

Inputs:

CT-SCS requires inputs that have impact on the supply chain and drug availability. They include:

  • subject recruitment rates and withdrawal rates,
  • country and site activation, and ramp-up profiles,
  • randomization method,
  • subject visit profiles, pack types, expiration dates,
  • country-depot-site supply chain network,
  • lead times for deliveries,
  • supply chain algorithms for re-order process.

Outputs:

  • daily levels of stock at each site and distribution center,
  • number of deliveries required to meet medication demand at the sites,
  • if medication is not available due to supply delays, the number of patients affected and the wait times,¬†amount of supply left at the sites at the end of the study.

For more information about our Clinical Trials Operations Planning, please contact Technology Multipliers.