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As cancer immunotherapies continue to emerge, the need for rigorous evaluation to assess the safety and efficacy of these products in clinical trials is critical. Doing so in the early phase setting requires a foundational focus in such areas as NME selection, protocol development, patient population, and investigator and site selection.

Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.

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Data on the relationship between investigator characteristics and cardiovascular clinical trial patient recruitment are extremely limited in scientific literature. An analysis of ALLHAT, the largest antihypertensive clinical study ever conducted, identifies key investigator and site characteristics that can strengthen subject enrollment.

Japan is increasingly a region where opportunities for global registration studies abound, supported by government policies as well as the medical community and its local population. However, incorporating Japan as an integral part of your global trial execution strategy does not come without its unique challenges.