Early, comprehensive feasibility studies and robust contingency plans are now firmly on the checklist for pharmaceutical companies wishing to optimise recruitment and retention of patients for clinical trials.
With many studies continuing to demand ever-larger numbers of patients, the cost of running trials has swollen to nearly 30% of companies’ drug development budgets. Any delays on the path to regulatory approval and launch can only add to this burden, yet 75% of clinical studies still do not stick to their timetable, notes a KeywordPharma report on Accelerating Patient Recruitment in Clinical Trials. Slow patient recruitment, and poor patient retention once trials are underway, are major factors in throwing trials off course.
Such is the importance of feasibility studies that most contract research organisations (CROs) and some clinical trial sponsors now operate a separate feasibility group, adds the report from a conference held by SMi in London. These studies should begin several months before planning for final site-selection, taking in more countries and sites than are strictly necessary to complete the trial programme, delegates were told.
They should also include a feasibility questionnaire for each prospective site, covering issues such as how many would meet the inclusion criteria; which patient databases are available for review; whether the site has adequate staffing to perform study-specific procedures; and how long regulatory or ethics committee approval takes in a particular country. The results from detailed feasibility studies may then be used to develop trial-specific recruitment plans, forming the core strategic framework for the final clinical trial.
Even with the most diligent feasibility studies, in around 50% of cases the level of patient recruitment is below expectations, the report observes. Hence the need for a strong, clearly defined and workable contingency plan. This may include opening trial sites in additional countries (some Eastern European markets may be particularly amenable) or identifying back-up sites in countries that are already part of the study.
The report delves into a number of related areas such as selection and training of investigator sites, working with partner sites or investigator hub sites that provide a one-stop shop for CROs and pharmaceutical sponsors, and the range of strategies and tools available to track or boost patient recruitment and benchmark site performance.
In advertising for trial participants, there is a shift away from traditional opportunism towards evidence-based strategies. For example, a number of companies are exploring technologies such as computerised clinical assessments as a means of qualifying trial candidates who respond to advertising campaigns.
The communication channels through which patients learn about upcoming trials vary widely from country to country, the report stresses. In Europe, for instance, 75% of patients learn about clinical trials from their doctor or referrals, whereas the corresponding proportion in the US – where patients are much more likely to hear about trials through the media – is 46%.
The challenges of retaining patients in trials are on a par with those facing recruiters. General negative perceptions about the pharmaceutical industry and its study practices have not helped: the SMi conference was held right in the wake of TeGenero’s disastrous Phase I trial at Northwick Park Hospital in London. There is a strong suspicion that participants are treated as ‘guinea pigs’, especially in developing countries, and a fear of being given inferior treatment or placebos.
Among the strategies proposed for improving patient retention rates are a ‘retention toolbox’ used by CRO Quintiles, which might include health promotions, ‘lunch and learn’ meetings or even spa treatments and gym memberships for patients that reach a certain milestone in the study; or patient healthcare clubs, with appointment reminders, e-mails and regular newsletters.
As the report notes, companies conducting clinical trials are “finding imaginative and evidence-based ways to recruit and retain patients in the face of a progressively more difficult competitive and public-image environment."
A complimentary copy of the report, sponsored by RSA and USP Clinical, is available for download from Keyword Pharma.