In the past five years the evolution of adoptive cellular transfer (ACT) for the treatment of lymphoma, leukaemia and myeloma patients has grown exponentially.
However, the successful development of cell therapies is dependent on the growing number of academic medical or hospital centres which are able and willing to participate in clinical trials. So what can sites expect and commit to when participating in ACT trials?
ACT studies are classified in the genetically modified organism (GMO) category, which has bespoke requirements. Additional time is required for the regulatory set-up period and it is essential to have a team on hand that is familiar with navigating the constantly evolving GMO regulations. As competition for ACT studies grows, and established centres of excellence experience resource constraints within their own regulatory groups, there will be an evolving drive and opportunity for community hospitals to engage in ACT clinical development. These institutions will need to equip themselves with regulatory expertise.
The intensive and demanding logistics of conducting ACT trials necessitates a high degree of organisation within institutions and sophisticated inter-departmental cooperation. Each commercial sponsor is likely to have its own audit requirements, although standardisation or universal accreditation of ACT studies remains an aspiration.
Considering the numerous and still evolving risks of ACT therapies, the importance of data management cannot be understated. ACT studies generate large amounts of data over a short period of the treatment cycle and as such, robust, validated electronic medical record systems are required. Data quality becomes a challenge with the large volumes of data, estimated to be up to 10 times that observed in other oncology studies. The site’s data coordinators must have sufficient time to enter data expeditiously as sponsor companies and regulators are constantly looking for updated safety information.
ACT will continue to make significant inroads into both haematological and solid malignancies with increasingly sophisticated and diverse cell constructs. Whilst the good news is that this is providing increased access for patients to treatments across a broader range of health care facilities, there is also increased competition for study site resources. Being prepared with regulatory intelligence, scalable logistics, resource commitments, as well as dedicated data management teams will present challenges that surpass those of other oncology clinical trials.
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This blog is an edited version of “Act Now – Cancer Trials at The Leading Edge” which appeared in Scrip Informa Pharma Intelligence on 26th November 2018. To view the full article, please visit https://scrip.pharmaintelligence.informa.com.