ICT
Lab Selection
Balance of Evidence Selecting a central laboratory partner for a clinical trial is too often based on subjective factors. But a more objective, project-specific evaluation will help ensure the most appropriate lab is picked The use of central laboratories (CLs) as an independent participant in clinical trials is a widespread practice, particularly given the requirements of regulatory authorities and study sponsors for high-quality, reliable laboratory data and the difficulties faced by local labs in organising the required tests in the country where the trial is being performed (1,2,3). CLs provide services ranging from conducting laboratory assessments and compiling lab test reports, to contracting courier services for delivering lab kits and biosamples to and from medical institutions where diagnostics and treatment of patients takes place (4).
Subjective Decisions Regardless of the important role of CLs in clinical trials – and the often substantial cost involved – it tends to be subjective, rather than objective, factors that influence the selection of a particular lab partner. In interviews with more than 50 sponsors, four reasons were commonly cited: ●● “A good recommendation from a person we know” ●● “One of our colleagues worked with this laboratory” ●● “We know a good specialist in this laboratory” ●● “We had a positive experience with the laboratory when working on a previous study” Another common approach is a sponsor’s mandatory request to use a specific CL with which it has worked before, in a kind of ‘preferred provider’ concept. The problem with this concept is the absence of guarantees that the chosen CL is the optimal choice for the particular study. Before a study starts, many sponsors perform projectspecific audits of pre-selected CLs. This approach is favourable to the preferred provider route since it provides an opportunity to obtain reliable and up-to-date information about the lab. However, it requires time and additional expense, as well as audits of several labs in order to optimise the selection. In addition, a lab audit performed by auditors who do not possess professional laboratory knowledge will not guarantee the high performance of the lab during the study. Furthermore, some consultants offer services to select CLs for clinical trials, but there is often a lack of appropriate criteria for ensuring objective and competitive selection.
62 ICT
l
May 2013
A Karelin, M Belotserkovsky, V Khokhlova and A Kumar at PSI
One way to address these issues and ensure a more objective selection of a CL is to use the algorithm set out in Figure 1 and explained here.
Initial Contact For the initial contact (Stage 1), CLs can be pre-selected using a company’s database, references or even an internet search. It is usually sufficient to contact three to five CLs but, as a general rule, the more complex the tests required, the more labs should be approached. For a preliminary contact, a short request about the available tests (with the indication of the study geomix) and general interest in the study is sufficient. Such interest is generally confirmed very quickly, so it is recommended that nonreplying CLs are not approached a second time as their lack of response tends to imply a lack of interest in the project. It takes no more than a week to gather initial information from all labs.
CL Feedback The second contact (Stage 2) is the most difficult and demanding. A CL’s early readiness to participate in a study may not necessarily prove to be the case further down the line. It is important to obtain the CL’s feedback on, for example, study design and logistics, the laboratory’s quality systems and some study-specific questions. Standard forms will enable all the necessary information to be collected in a single step. One suggestion is to use a project-specific pre-qualification questionnaire and a general lab pre-qualification questionnaire, which together contain about 30 questions covering all aspects. Any laboratory that can act as a CL can provide all the requested information quite quickly, within two to three weeks. Selecting a CL requires a cross-functional effort with independent participation from a project manager, who will oversee and approve the selection, as well as a lab specialist and a quality assurance auditor, to request and assess the information that comes in. It is recommended to appoint a qualified lab specialist to coordinate the process.