Effective communication of clinical trial benefits to potential investigators, study sites and patients can not only add “billions of dollars” to a company’s top-line growth but can have a critical impact on the bottom line during drug development, claims a new US report.
Clinical communications are a vital part of keeping studies on time and budget, say benchmarking specialists Best Practices, LLC. The starting point is a well-defined targeting strategy. This calls for rigorous segmentation and screening, using multiple sources to create a target list that weighs the complexity of the protocol against performance variations particular to the trial, such as drop-out probabilities or investigator experience and motivation levels.
Achieving clearly differentiated positioning for a trial requires in-depth market research to identify crucial motivational drivers behind investigators and study co-ordinators, notes the report on Finding and Keeping Top Clinical Investigators. Communications teams can then create tailored messages for delivery through the most effective communications channels, be they contract research organisations (CROs), patient recruitment organisations, regional clinical research associates, professional associations or advertising through traditional media and the internet.
Need to motivate study sites
Timely and frequent communications to inform and motivate study sites are also key, the report says. Communication problems among study sites, CROs and pharmaceutical companies are one of the main reasons for delays, cost overruns and misunderstandings in clinical trials. Specific barriers include lack of early input on the protocol, primarily from study sites; delayed protocol synopses after the confidentiality agreement has been signed; late payments; and delayed answers from CROs or pharmaceutical companies.
Trial sponsors can also reap “tremendous benefits” by teaming up with study sites and CROs to deploy multi-channel patient recruitment programmes, Best Practices believes. With ever-rising numbers of patients needed for regulatory approval, more complex protocol designs and increased patient wariness about study risks, the difficulty of managing large-scale trials has increased “dramatically”. With the deeper involvement of pharmaceutical companies in recruitment, the report points out, trial sites are building up knowledge and skills in patient demographic and psychographic analysis; message development, media planning and buying; and channel outreach strategies.
In addition, pharmaceutical companies are developing a portfolio of educational tools and motivational benefits to improve patient retention in trials. These are then customised to individual study sites and patient populations, giving study participants a broader understanding of the clinical trial process, for example, or information about the risks and rewards of treatment.
Optimising clinical communications can mean better-selected trial sites and patients who stick with the protocol until it is completed, Best Practices says – no small advantage in an environment where a drug with projected peak annual sales of US$1 billion can lose as much as US$2.5 million for every day that sub-optimal clinical trials delay product launch.