It’s no secret that conducting a clinical study continues to be a challenge. Not many trials are finished on time and within budget for a multitude of reasons. That said it is expected the industry deliver trials according to the plan, while bringing new medicines into the market quickly, but efficiently as possible.
So how can a sponsor devise a realistic plan for a clinical trial? There are a number of steps that can be established prior to the start of the study. Here are three things to consider:
1. Recruitment period and recruitment plan
When developing a recruitment plan, it’s important to set high level benchmarks for the enrolment period. This is crucial as both the inclusion and exclusion criteria, and the study procedure will determine the success of the recruitment period.
A thorough feasibility analysis should be carried out to gauge how well it’s going. The analysis should preferably be carried out in-house by the sponsor company, although parts can be outsourced to a CRO. That said by doing it in-house, the staff will have a greater understanding of the number of available patients. Once the feasibility analysis is complete, the results must be factored into the enrolment plan. Some of the factors that should be considered are as follows:
– Competitive studies;
– Patient retention;
– Average recruitment speed of patients per months and site;
– Number of countries, proposed countries;
– Number of sites;
– Anticipated dates for the following milestones:
1. First patient, First visit
2. Last patient, First visit
3. Last patient, Fast visit
4. Clinical study report
Source: Ulrike Grimm
2. Overall study plan
On top of timelines, milestones, objectives and scope, the study plan must account for the trial budget and the resource plan.
The trial budget in particular typically factors in the total of all offers received over the course of the bidding process. What’s more, the budget should also account for the change orders that will occur throughout the course of the study. The conventional wisdom is that change orders are inevitable, so there needs to be enough leeway in the planned trial budget.
Close scrutiny of resource needs is important as oftentimes it’s easy to misjudge what activities need to be carried out in-house when large parts might be outsourced to a vendor. Therefore it’s important to draw on previous studies (similar in size and scope) to anticipate the amount of internal resources that will be needed.
3. CRO management
CRO management is a process that begins from the selection stage. Typically, the RfP (Request for Proposal) is drawn up and sent to prospective partners. Selection of a CRO will be determined based on, not only the sponsor’s budget, the CRO’s level of expertise, their experience working in a specific therapeutic area, and the team. It goes without saying that a strong working relationship between the sponsor and the CRO will have a significant bearing on the outcome of a trial. An insight into how well the teams from both sides of the aisle will work together can normally be gleaned from the bid defence meetings.
Over the course of a trial, it’s natural sponsors will witness high turnovers within a CRO. Therefore, it’s always beneficial to determine insurance policies from the outset. Furthermore, have in place points of contact on both sides to communicate the various issues that crop up during the study. Regular meetings between the sponsor and CRO should be established in the beginning.
Developing a comprehensive strategy covering all facets in the clinical trial will pay dividends in the end. Be sure to closely track the progress of the trial once it’s underway. By simply covering all bases that will allow the study team to be one step ahead when managing unforeseen circumstances.
*Adapted from Operational Excellence in Clinical Trials by Ulrike Grimm