Soothing Recruitment and Retention Headaches the Logistical Way: Rare Disease Clinical Trials


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Soothing Recruitment and Retention Headaches the Logistical Way: Rare Disease Clinical Trials

Part 3 of 3

By Franc Jeffrey

Rare Disease Trials
Subjects taking part in rare disease trials can often be travelling from many countries or indeed long distances within a country to just a handful of sites.  Advance planning of subject logistics is key to keeping control of costs.  It is wrong to assume that travel between countries that are close in proximity will result in the best value for money.

The travel management service can help with budgeting in these cases.  Very often relocation can be a more cost-effective option than regular cross border travel.   Relocation can also be less of an ordeal to the subject than a gruelling travel schedule that can last a couple of years.  A travel management service with clinical expertise will have the ability to help with relocation services.

A common error when planning trial logistics can be underestimating the size of a country. Certain studies, including rare disease studies, may only have three of four sites that are suitable for testing in any given region.  It is easy to assume that domestic travel is relatively straight forward and cost effective, this is often not the case.

Pre-empting problems
During the life of a study, one of the largest benefits that a service such as this brings is that all members of the team dealing with subjects are trained to listen carefully to every subject and report their concerns or potential reasons for missing study visits before it actually happens.  The list of reasons for dropping out of a study are not things that usually spring to mind. For example, one subject could not wear a seatbelt due to the pressure it placed on them.  The car company used for airport transfers explained that if the subject did not wear their seat belt the driver would be fined should they be stopped by the police.  After a consultation it was agreed that the sponsor (with the approval of the IRB) would pay any fine in the event of the driver being stopped.

In another case, a family with two children took part in a rare disease paediatric study would travel by plane and then rent a car to get to their nominated site for infusions.  On arrival at the airport the car rental company allowed the family to choose any car of a certain size, with the theory that the renter would get to try any car they liked.  While the appeal of any car would bring a smile to many faces, in reality this procedure meant the family then had to wait for child seats to be fitted, which added a delay to an already stressful journey.  On finding this out we were able to seek permission to deviate from the study travel policy and utilize a car rental vendor who would have the car pre-fitted with child seats when they arrived, thus reducing stress and helping study retention.

The benefits of outsourcing these crucial aspects of clinical trials are numerous.  Ultimately the sponsors retain control of costs and receive meaningful reporting.  The CRO has a greatly reduced amount of administration, removing the hassle of organising subjects travel and reimbursing expenses, allowing them to concentrate on their primary role.

Additionally improved budget control and cost savings can help the sponsor reduce expenditure through providing a study schedule that ensures travel can be effectively planned in advance.  In turn, this ensures smooth travel arrangements, which leads to improved continuity in studies, happier and motivated subjects and a reduced risk of missed appointment visits or subjects leaving a study early, which are both an inconvenience and an expense to the sponsor.