Mr. Alexander Alfimov graduated from St. Petersburg Military Medical Academy in 1987. After completion of military service as a navy physician he worked in the Moscow Institute of Urology. He defended his PhD in prostate cancer and started there as clinical investigators. Alexander joined the pharmaceutical industry in 1994 as a Medical Manager in Zeneca. Currently he holds the position of Chief Scientific Officer and is member of the Pharmaceutical Executive Committee in Novartis Pharma Russia, being responsible for medical affairs, clinical operations, scientific operations, pharmacovigilance and regulatory interface. Alexander was the impressive speaker of the Optimizing Clinical Trials in CEE and CIS region (13-144 February 2008 in Vienna) conference.
1. How to reach and maintain the right balance of investigator’s pool and co-operation with KOL investigators in order to build commercially successful future products?
Participation of national KOLs in clinical trials is crucial for fast product success on the market. Unfortunately very often top tier KOLs are not high recruiters and are not invited by CROs into sponsors’ projects. If you have only one or two international trials placed in the country, this will substantially delay the product’s growth after national registration.
Sponsor should review and approve investigator sites selected by CROs and propose important KOL sites if they are omitted.
If you have plenty of trials and they are in-house, it’s easy to identify in co-operation with local marketing department and invite proper KOLs as investigators. This will guarantee involvement of all required KOLs in at least one international trial.
However, composing investigators pool based only on KOLs may jeopardize patient recruitment. Therefore, you should also have in your investigators list enough trial sites with proven patient recruiting abilities and in addition discuss with potential low recruiters the use of professional patient recruiting service.
2. What are the key success factors for recruitment activities planning?
Local project team is lucky when recruitment activities are planned centrally at the protocol designing stage. If not, then additional activities for patient recruitment should be planned at country level.
Key success factors here are:
• Selection of proper patient recruiting tool. Some projects are responsive for patient advertisement, for others referral strategy is preferable.
• Collecting justified recruitment forecast from investigators. We should go little further than just asking the figure or seeking confirmation for proposed recruitment target. I mean we should ask potential investigator to provide the some evidence to confirm declared available patient’s number.
• Evaluation of investigators’ past performance.
3. How to build effective relationship with investigators? Is financial support a crucial motivating factor?
We face a strong competition between trial sponsors and CROs for patients and for investigator’s attention. If investigator put himself in the situation of having several similar projects at the same time, he will most probably prioritize recruitment based on compensation size. We provide equal compensation to all investigators and do not consider the grant increase as a competition tool. In this case we will focus on recruitment in other trial sites.
Now we face another type of competition, we have to compete for investigators attention.
Even when investigator does not have similar simultaneous trials, he/she may not pay enough attention to our project in such extend that recruitment starts to suffer. In this case building relations will help.
I suggest the following simple and effective methods: motivate monitors to meet PI at each occasion, increase your share of voice with the help of colleagues from other departments, and contact your investigators regularly in between studies period.
4. What are the opportunities for on-line patient recruitment in Russia?
Novartis has own internet site inviting patients on-line to take part in clinical trials. It is mainly oriented on US public. Although it contains information on Russian sites, our patients do not use it. We plan to work with local resources, for example www.clinical-trials.ru contains the comprehensive list of clinical trials approved by Russian authorities, objective and user-friendly information on clinical trials for patients and medics and options for on-line patient recruitment campaigns. National and local ECs will review patient-directed ads including on-line materials. We are just starting to work with this service and I think soon I will be able to share our experience with it.
5. Do you have experience with direct-to-patients-advertisement or do you plan to do in the future in Russia?
Direct-to-patient advertisement is starting to develop in Russia. We have a positive experience in one onychomycosis project and plan to incorporate method into recruitment strategies for selected trials.
6. What is your standpoint on cooperating with recruitment service providers in Russia?
I know only two professional recruitment service providers in Russia. Until now the main option to safeguard recruitment was moving to regions and involving new trial sites not engaged in clinical studies before. This is logical step, however it has certain limitations due to travel distances affecting monitors’ workload and need to invest into investigator’s staff training. I am sure that in parallel to expanding trial site base the new recruitment providers will appear in Russia. The current model when patient recruitment is the responsibility of only investigators brings to unpredictable recruitment. There are two types of high recruiters: the lucky investigators having centralized patient flow in their own institution and active investigators attracting patients from other hospitals. This second case represents the function that can be better performed by focused professionals to the benefit of sponsor, patients and investigators.
There is another important benefit for the sponsor. The dedicated patient, attracted by professional recruiters is less likely to withdraw from the trial.
7. What are the standard elements Novartis Russia is applying to stimulate recruitment process?
Stimulate recruitment means apply pressure on investigators. Unfortunately we have to do this and these activities are the same as in other companies. Namely: regular contacts, reminders, meeting, hiring additional co-coordinating staff, opening additional sites. As you see these measures not only bring tensions in relation with investigator, but also require additional budget.
8. How did you like the event? What was the key learning for you at the conference?
It was a great opportunity to absorb useful hints, ideas and understand trends in clinical trials. It was especially interesting for me to see how selection and interaction with CROs is developing.
