GLOBAL CANCER POLICY-MAKING
company to fill an order. These policies did not permit shipment during the “design” phase of the protocol. The National
of a batch of drugs to each country and essentially excluded Institutes of Health (NIH), USA, guidelines for preparing
obtaining the drugs directly from the company. Since this protocols, modified by INCTR’s Ethical Review Committee
company had “local suppliers” in nearly every country (ERC), were used to facilitate discussion of, and design of the
participating in the study, INCTR then began negotiating protocol document and informed consent forms. Because the
directly with local suppliers to purchase drugs at the lowest PIs were from different institutions in different countries and
price possible. Drug prices were often double the price were working in a multi-institutional study, a publication policy
significantly more expensive than those purchased directly and agreements about presentation of data were included in
from the drug company. the protocol. An oncology pharmacist from NIH reviewed all
It has also proved difficult to estimate consumption. drug administration procedures and a biostatistician from NCI
Estimates were based on the previous year’s patient but assisted in the preparation of the statistical methods section.
accrual varied from year to year at each site. At times The PIs agreed upon the choice of external scientific reviewers
purchased drugs expired before consumption and were not for the study, and after incorporating suggestions made by the
even used for any other cancer patients who might have reviewers, the protocol underwent review and approval by
benefited from the drugs even though INCTR’s policy was to INCTR’s ERC. The protocol was then submitted to the
ensure usage to avoid wastage. There were incidences of institutional review boards (IRBs) of the participating
premature exhaustion of stock that led to disruptions in institutions for approval.
treatment. When additional requests were made for “out of Prior to the commencement of patient accrual in 2004, an
stock” reasons, patient accrual and the documented drugs and implementation meeting was held at ORCI for all PIs and their
dosages administered were tallied by INCTR. Study sites were respective research team personnel, including the data
required to provide an accounting for study drugs managers. The protocol document and the study case report
administered to patients, but these frequently did not match forms (CRFs) were reviewed in detail. Instructions for the
what was reported as being consumed. Sometimes, drugs were completion of CRFs were provided. When new centres joined
given to other patients who did not have BL, who arrived in the study, their personnel were provided with similar training.
relapse, or who were not otherwise eligible for the study. Some Training in the use of the study database was provided in a
institutions could not account for consumption of INCTR workshop for the four original participating centres.
purchased drugs due to mixing study drugs with hospital stock
supplies of cytotoxics. Data management processes and data monitoring
The indefinite purchase of drugs by an external organization is The initial database designed for the study mirrored the study
unlikely to be a sustainable mechanism for the treatment of this CRFs and had built-in business rules to minimize data entry
very curable cancer. Although the cost of drugs varies among errors. Data was entered “off-line”. The internet was only
countries and often among suppliers within countries, first line required to transmit the data in compressed files to INCTR via
treatment costs approximately US$150 to US$200 per patient email. Once data was received from individual centres, it was
and second line treatment, US$500. Because the results are merged into INCTR’s master database containing data for all
1
excellent and have now been published , it seems timely to lobby centres. Over time, due to the number of patients enrolled and
governments to see that hospitals, particularly those funded by difficulties in sending large files or restoring data to the sites, it
governments, are provided with adequate supplies of these was decided to re-vamp the database (called TCBLA),
drugs to treat all children with BL. Indeed, the introduction of integrating updated technologies and database applications.
affordable health insurance, such as the plan implemented in The new TCBLA system was also designed by taking into
Rwanda7,8, might be a way to ensure that cancer care is provided, consideration that the internet is still often unavailable at the
particularly for the rural poor. sites. Instead of sending data files by email to INCTR, data can
now be “uploaded” to the central database server via a process
Research team personnel compliance with protocol-related called “synchronization” which requires minimal internet
procedures and data management connection time. This ensures that data entered by the sites are
Training and education in the basic principles of clinical securely stored and “backed up”. Therefore, data can be
research – not only for PIs, but also for their respective restored in the event of computer malfunctions or theft. This
personnel who were designated to be involved in the care of process also eliminates the transmission of computer viruses.
the protocol patients or in data management - was provided in When modifications to the system are required, these can be
the context of the protocol itself. Training began with the PIs transparently and automatically transmitted electronically to
30 CANCER CONTROL 2013