Early Phase Clinical Pharmacology Studies Obstacles
A significant and expensive hurdle in the successful execution of clinical trials is participation; recruitment and maintenance of adequate people, with the relevant health profile, to provide the required data gathering for drug programmes.
There are a number of key factors that contribute to robust and effective recruitment and retention effort:
- Covid-19. Ensuring that study processes and participation are efficient, thorough, and above all, safe, must be top of mind as clinical trials continue in the reality of Covid-19. Processes have to be adapted and redesigned accordingly, to respect all applicable guidelines. Sanitation and social distancing are vital elements of any activity, to ensure the health and safety of staff and potential participants.
- Study design. The design of your protocol, in particular the inclusion and exclusion criteria, will have a significant impact on recruitment success. Ensuring that the criteria adequately represent the target population and are precisely defined, while maintaining as much flexibility as possible, helps to maximise participation opportunities, and minimise screening failures.
- Recruitment strategies. A robust database of participants with complete medical profiles for accurate, targeted reach-out is a must. If you need patients or special populations, strategic partnerships and alliances with local hospitals and clinics allow for expanded access. Altasciences has a database of over 345,000 profiles and a self-serve participant portal where people can register themselves for trials that match their profile. They also have excellent relationships with local hospitals and specialists for challenging patient recruitment.
- Screening. Robust informed consent and continuous communication processes contribute to efficient screening practices. It is helpful to deliver the consent form prior to the visit, whenever possible, to allow sufficient time for reading, discussing with medical staff one-on-one and signing. Altasciences’ workflows are planned with potential high-failure procedures conducted early in the process, to minimise costs to clients and save time for participants. With continuous improvement projects in place to optimise wait times, efficiency and quality of participant experience is always top of mind.
- Retention. After the investment of recruitment and screening, keeping participants on trial, whether for an extended stay or return visits, is fundamental. At Altasciences, everything is designed to keep participants safe and comfortable. Participants are well informed and understand how essential their participation is to clinical research and drug development. In addition, the purpose-built facilities and services (high-speed wifi, TV and movies, books and other activities, appetising meals that are compliant with protocol requirements, well-appointed overnight areas, etc.) encourage participants to stay engaged.
At Altasciences, their record speaks for itself, with 95% full panels delivered year after year. A dedicated participant relationship management team is always available, managing the needs of sponsors and participants throughout every step of the study.
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