How Site-Level Recruitment Forecasts Could Improve Clinical Supply Planning
By Alan Salter
The effort to make clinical trials take less time and cost less money has a purpose beyond the study budget. For patients waiting for better treatment options, avoidable delay can have a very personal cost.
Recruitment is one place to examine that opportunity. If a study team could more reliably predict when eligible patients would enroll at each site and what reaching those goals would cost, it could make earlier decisions about recruitment support and the supply needed to serve those participants.
The hypothesis is worth exploring: better site-level recruitment forecasts, acted on effectively, could improve enrollment goal attainment and reduce avoidable changes downstream. Where recruitment is holding back the study, those improvements could also help bring reliable evidence forward. For therapies that ultimately prove safe and effective and receive the necessary approvals, that may contribute to earlier patient access.
Make The Forecast Useful At The Site Level
A total enrollment target gives the study a destination. Planning the work requires a clearer view of how individual sites are expected to reach it.
That view should connect the approved protocol and eligible population with local recruitment conditions, the cost of outreach, and the site's ability to support candidates through screening and enrollment. This work can begin within sites the sponsor has already selected.
The enrollment milestone needs to be clearly defined. An inquiry, a screened candidate, an enrolled participant, and a treatment start are different events. The relevant definition should follow the protocol, and the forecast should show how people are expected to progress between stages.
Location matters because the population a site serves, travel demands, and available recruitment channels can affect that progression. A useful forecast would show expected enrollment by date, the likelihood of reaching the site's target, and a range for recruitment cost, with the assumptions visible. Site teams and prospective participants can help test whether those assumptions reflect practical conditions. ICH E8(R1) encourages input from investigators, site staff, and patients in study design, including insights into recruitment feasibility and participation burden.1
Use The Prediction To Improve Recruitment Decisions
Better prediction becomes useful when the team can act on it. A site expecting sufficient inquiries but limited screening capacity may need a different response from a site struggling to reach eligible candidates.
That distinction could shape how outreach is directed, what information prospective participants receive, and how the site manages follow-through. Recruitment communication needs to help people understand the study accurately, while the receiving site needs the capacity to respond and support the next steps.
Funding decisions could then reflect the cost and likelihood of achieving the enrollment goal. Cost per inquiry remains an activity measure. Cost per participant reaching the defined enrollment milestone gives the team another view of whether that activity is producing the result the study needs.
The aim is to identify where additional effort could help and where a different approach is needed. Decisions should continue to support the protocol and the intended study population. An apparently inexpensive recruitment channel has limited value if it fails to reach the people the study needs to include.
Give Clinical Supply An Earlier Picture Of Demand
For clinical supply teams, the value lies in knowing where and when treatment demand is likely to appear.
Consider an illustrative study with two already selected sites. One is seeing eligible candidates progress faster than expected; the other is receiving inquiries but taking longer to complete screening. The study's overall target may remain unchanged, while the timing and location of supply demand move.
If the team sees that pattern early enough, it can review site allocations, upcoming packaging commitments, and shipment timing before the next decision becomes difficult to change. Product may need to arrive sooner at the first site, while a planned delivery to the second may deserve another look.
The response depends on shelf life, approved labeling, available stock, and distribution lead times. Changes must remain within the study's quality and approval processes. ICH E6(R3) addresses timely investigational product provision alongside safeguards for participant safety, product integrity, and blinding where applicable.2
Faster enrollment can also bring spending and product requirements forward. Clinical supply teams and other trial service providers need enough notice to support that acceleration. The forecast creates an opportunity to prepare; the operating response determines whether the opportunity becomes useful.
Translate Predictability Into Time And Cost Benefits
More dependable enrollment could reduce the need for repeated recruitment recovery exercises. It could also help avoid some urgent shipments, unused inventory, and supplier changes caused by a late understanding of demand.
Those improvements would have different effects on cost. Some could reduce total spending. Others could keep the study within its existing budget or allow funds to support another trial or development activity. Bringing expenditure forward to support faster enrollment may still require additional near-term funding.
The effect on the overall timeline also needs to be understood. If recruitment is on the study's critical path, earlier enrollment completion could bring subsequent milestones forward. Required treatment, follow-up, data review, and regulatory assessment still have to take place.
That makes more predictable attainment valuable even when the final completion date cannot move. The team can make commitments with a clearer understanding of the demand and timing it is asking others to support.
Test The Hypothesis Against Actual Performance
A credible forecasting approach should show whether its predictions hold up on future activity. Matching historical data is an initial step; the operating question is whether the forecast helps the team make better decisions before results are known.
Compare predicted enrollment timing and cost with actual performance at each site. Review how uncertainty ranges behave, where forecasts repeatedly miss, and whether missing or delayed data affected the result. Keep the cost definitions consistent, including which recruitment and site-support expenses are counted.
Then examine the outcomes separately. Did sites reach enrollment goals more reliably? Did the team need fewer recovery actions? Were supply changes identified earlier, and did avoidable costs fall? Faster enrollment following a new forecast does not, by itself, establish that the forecasting approach caused the improvement.
This distinction helps the team identify what is working and what needs to change. It also gives procurement and supplier management a sounder basis for discussing performance, commitments, and value.
Keep The Broader Patient Benefit In View
The larger opportunity is to reduce avoidable delay and cost in the work needed to evaluate new therapies.
When more efficient recruitment shortens a development program, it may help effective treatments reach patients sooner, subject to successful study results, regulatory approval, and practical access. Depending on the therapy, earlier access could mean better quality of life or longer life. Recruitment efficiency contributes by reducing avoidable delay in generating the evidence needed for those decisions.
Lower trial costs would also reduce one component of the investment required to develop a medicine. Spread across the same number of future doses, that would represent a lower development-cost burden per dose. It could create room to support affordability, but the price a patient pays also depends on pricing, coverage, and access decisions. Development savings do not automatically become lower medicine prices, a distinction consistent with the Congressional Budget Office's analysis of pharmaceutical pricing.3
Finally, a shorter successful development timeline could allow the pharmaceutical company to earn revenue sooner, subject to approval and launch readiness. That is another potential benefit of reducing avoidable delay, with the patient opportunity remaining the reason this work matters.
References
- International Council for Harmonisation. ICH E8(R1) General Considerations for Clinical Studies. Final guideline, Oct. 6, 2021. Section 3.3.3. Read source
- International Council for Harmonisation. ICH E6(R3) Guideline for Good Clinical Practice. Final guideline, Jan. 6, 2025. Annex 1, section 3.15. Read source
- Congressional Budget Office. Research and Development in the Pharmaceutical Industry. April 2021. Discussion of expected revenues and drug pricing. Read source
About The Author:
Alan Salter is a consultant specializing in procurement, supply chain and business transformation. His experience includes clinical partner management at Takeda, where he worked across R&D, procurement and supplier teams to improve governance, planning and operational execution. He has also held roles at GE, Black & Decker, and C.R. Bard. He began his career as a U.S. Navy Supply Officer. In his work, he leads complex changes across functions and suppliers, making responsibilities and dependencies clear and ensuring seamless delivery. He holds a BA in Economics from Miami University in Ohio and is Six Sigma and Lean Certified.