Getting the right results from a clinical trial starts with choosing the right site as its success is determined by the clinicians who recruit, enrol, treat and evaluate trial patients.
The experience of site staff, such as investigators or study coordinators, the availability of suitable patients and the ability to perform required clinical assessments are essential and have to be considered when selecting a site.
An often underestimated process, site selection requires due diligence on the part of the sponsor to ensure the clinical trial meets all consideration essential to the success of a study. The availability of specialised diagnostic and therapeutic equipment, a track record with previous, similar trials, the geographic location and regulatory history have to be taken into account in the same manner as contractual and budgetary restrictions and the anticipated rate of patient accrual.
Ahead of Arena International’s Achieving Operational Efficiency in Clinical Trials conference in Brussels in September 2011, Pharmaceutical-technology.com speaks to drug development company Advancell project manager Marta Rayo Lunar about exploring techniques that improve site selection, in order for a more successful clinical trial from the sponsor’s point of view.
Elisabeth Fischer: When is the right time to select a site for a clinical trial?
Marta Rayo Lunar: In theory, the site selection comes after the feasibility studies. When you have identified all your potential sites, you should decide the number of sites you want or need to open and select. In my opinion, the final site selection has to be made when the protocol synopsis or design of the study is clear. After that, you can slightly change or modify the plan but the principal point of the synopsis should be clearly defined because those things have to be tailored with the clinical site.
EF: What has to be considered when selecting a site?
MRL: Site selection always depends on the specific design of the study but that aside you first of all need to decide on the geographical territory and evaluate the potential sites available.
As a second step, you need to consider your target patient population as this might take you to some specific clinical sites and exclude others. If for instance, you conduct a paediatric trial, you have to select different sites than for dermatological trials. The patient population will help you explore possible sites.
Of course you need to ensure the sites fulfil the protocol requirements of the study. One approach to making the decision is to ensure they fulfil all the requirements and it’s recommended to have defined your requirements and your demands beforehand. Those requirements can change from trial to trial.
There are some general points you can always consider, as experience from previous similar studies has shown. You always have to ensure the site comes with sufficient resources and that resources are available to your study.
The staff available on the site very much matters to the process of a site selection. If there are staff available on the site, you have to evaluate their interest and motivation. If people are not motivated and not willing to participate then they won’t conduct a correct study.
EF: How does wrong site selection influence the success of a trial?
MRL: Wrong site selection will definitely have a huge impact on the success of a trial. If you select a wrong site you will most probably not reach your goals and you will end up with delays and higher, unplanned costs.
EF: How does site selection influence the recruitment of the right patients?
MRL: There is a direct connection between successful site selection and recruitment of the right patient. Once the site has been selected, one important part of the success is that all the staff from the site involved in the trial understand the protocol design, knows the targeted patient population, knows its characteristics as well as the specific study procedures.
If all of these things related to the protocol are well-understood, the investigators, who select and recruit the patients, will be able to recognise the right candidates.
Once they have the right patients in mind, the second step is inform them about the trial and convince them to participate. So the second step would be the relationship investigators have with the patients. When they have a close relationship with their patients, they will able to recognise the right person for the study and be able to convince them to participate and involve them in the study.
EF: How can pharmaceutical companies improve site selection?
MRL: Companies can improve site selection by working with a specialised team. In a first instance, they can involve people from the contract research organisation (CRO) and delegates from the sponsors. Improvements in site selection can be achieved by using regional experience.
In many cases, companies can get this experience from the CRO, using their network of relations to improve site selection. The important thing is everyone knows the requirements and the demand, which must be defined in process plan.
The point is it’s not easy to improve site selection any further because it always depends on the design of the trial. There are some tools that could be improved, especially on the information side. At the end of the day, we are working with people on the sites and there can be conflicts of interests between different parties such as the investigators, the clinical staff, the board of the site or the head of the department. You could create some very scientific and technical tools to improve the site selection but in the first place you need to deal with people.
Also professional networks might help to create forums in which professionals of clinical trials management can share experiences and exchange knowledge about site selection. It definitely would improve the site selection if we shared previous experience with those networks.
EF: What is the right strategy to forecast site budgets and minimise the potential for financial constraints?
MRL: The only way to forecast a budget for a study is to be as realistic as possible. At the end of the day everything that goes over budget is unsuccessful evolvement for the study. For example, if you don’t have the patients on time you need to maintain more time for a trial, which means you need to plan more time on the site, more personnel, which will cause extra costs and further delays.
Usually, the investigators estimate the availability of the study population based on the budget. So you need to be able to rely on some realistic and trustful figures in your budget.
It’s always good to cooperate with investigators in other things than choosing people because they know the site and are close to patients, which can help to estimate the budget in a realistic manner.
But even if you have a well-estimated and realistic budget, things can always happen and recent experience has shown the best way to minimise the potential for financial constraints – especially at the moment with the problematic and complicated economical situation in Spain and Europe -is to stick to your budget.
If you need to ask for some extra money in your budget you will suffer from constraints. So the best way is to include an item in your budget, such as a contingency plan, from the beginning on. Be realistic and not positive and include the possibility that something happens.
EF: What procedures can be put in place to increase capacity within sites for the effective use of resources?
MRL: It really depends on the design of the study but there are some general procedures that you can always put in place. One example is to use advertisements such as posters and flyers to promote your trial. You can advertise with professionals or patients but the content of the information should be really different from each other.
If you want to create this kind of tool for professionals, you can share your study with them but if you want to promote your study within patients you always need to be aware about ethical issues in different countries.
Considering today’s use of social networks, they also can be used to your advantage and help you to increase resources. Especially social network sites around clinical facilities or patient societies can be used to promote your study and actively look for patients.
You can also promote your trial in local media, for example in the hospital section of a newspaper. One procedure that really can increase the capacity of your site is to include a local hospital. Especially in some less populated areas. Finding a regional hospital that includes a clinical site can really increase the capacity.
Arena International’s Achieving Operational Efficiency in Clinical Trials takes place on 20 and 21 September 2011 in Brussels, Belgium.