Clinical supplies & logistics Hope
linical trials are the backbone of medical advancement, paving the way for new treatments and potential cures. Despite this, many patients in urgent need of novel therapies face the challenge of accessing treatments that are still undergoing testing or have yet to be approved in their country. Access programmes for clinical trials, also known as early access, compassionate use, or expanded access programmes (EAPs), are designed to bridge this gap. These programmes not only hold promise for patient recovery but also offer substantial benefits for a wide range of stakeholders in the healthcare ecosystem. Ever since the Investigational New Drug (IND) application was established in the US in 1987 in
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understanding and
The benefits of access programmes for clinical trials extend beyond patient recovery and treatment. Providing patients with treatments or drugs that have not yet been approved in their country is advantageous not just for patients, but for all stakeholders involved. Phoebe Galbraith speaks to Sheela Upadhyaya to explore how the benefits of access programmes can be maximised and how best to design a programme to meet everyone’s needs while managing outcomes and uncertainties.
response to the AIDs crisis and growing demand for drugs in development, EAPs have evolved significantly worldwide.
This reflects a growing commitment to patient- centric healthcare. When no other options are available to patients with serious or life-threatening diseases, these programmes provide pathways for patients to access drugs in development when there are no other alternatives.
Compassion and commercialisation Typically, EAPs consist of several key components: patient eligibility criteria to ensure that those who genuinely need the treatment and have no other
Clinical Trials Insight /
www.worldpharmaceuticals.net
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