The increasing delays in approvals from authorities and lack of enrolment numbers pull a clinical research trial down in a huge way. The number of sites increases in the hope of achieving targets, the level of quality drops due to the smaller number of supervising personnel, the budget shoots up and the problems just keep on piling up.
All this is a common theme seen with many clinical research trials and this is what is collectively called a Scope Creep. Now, if you are about to start a clinical trial or need help with discovery informatics, then you must naturally be wary of such things.
To help you avoid such scenarios, here are four tips that you can apply in your project to get the results you want.
1. Identify realistic goals from each investigational site along with a timeline
Everyone and everything has a limit and this is exactly why you should always set realistic goals for the whole team working on the project. You should plan the workflows to be followed at the investigational sites in advance. You should have a thorough vetting process in place for all such sites and identify the key variables.
If you see the potential of a timeline-related problem creeping in, then you should include that in your initial flowchart so that you can make the necessary changes in other departments as well. There is no better way to tackle scope creep than meticulously planning everything in advance.
2. Spend more time initially to estimate potential site problems and time management issues
Continuing on the above point, you should always have a contingency plan in place to tackle a crisis. Sites seeing a drop in personnel or volunteers or a sudden change in the policy are all changes that no one can anticipate and hence people rarely have a backup plan. This is where you need to stand out by having a plan in place to solve such issues with ease.
Having all this planned out before the negotiations with your partners always helps. Furthermore, you should have enough leeway in your budget to accommodate such changes.
3. Establish a well-structured budget design
When you work with a Contract Research Organization in India, you have to sort out the budget well in advance as they are your top partners. While some quote a flat rate, some charge you on an hourly basis for every visit. While planning the budget, multiple facets like the cost of conducting a site initiation, closure visit and regular monitoring and so on have to be considered.
Through all this, you must keep the circumstances of both the sponsor and the trial in mind to formulate the ideal budget. If you have a well-structured work plan laid out, then you may opt for a CRO that charges you on an hourly basis and if not, then a flat rate is much better.
4. Have regular conversations to discuss the proceedings
Just like any workspace, honest conversations between two parties matter a lot during a clinical research trial as well. This goes for everyone involved – the chemistry CRO you will be working with, the investigation site staff, sponsor staff, and volunteers and so on.
Once you choose the all right partners for your cause, you should build good relationships with everyone and work as a cohesive unit to achieve the desired results within the scheduled time.
You should be able to challenge each other and find success in the most fruitful manner possible. The absence of healthy working relationships can lead to scope creep in no time.
For any clinical research trial to go well, there are dozens of factors that need to go right. The application of the above tips will surely help you achieve top results in the estimated timeline.