Meet the Orbiters – Sheena

Firstly, the purpose and cause of Orbit. This is something that strongly aligns with my values and I like helping people in need.

The last but most important factor that made me join Orbit was the feeling of connection with the team. Even during the interview, I felt that we vibed well and this is most probably because we all have similar values. True enough, when I went to Germany during my first week, we were working together so naturally as if we had already been colleagues for a year!

Q: Since joining Orbit, what is something that surprised you about Parkinson’s or chronic diseases in general?

Parkinson’s Disease isn’t a disease that is very well understood by the general public, and it doesn’t help that the mass media typically portrays the disease with only tremors. Most people are unaware that Parkinson’s Disease can even manifest as bradykinesia (slowness of movement) and even rigidity.

What saddens me the most is that many patients don’t have their symptoms well-managed because of the delicate nature of the medication regimen and the difficulty around continuous, objective symptom monitoring. Personalized treatment is definitely much needed for these patients.

Q: What makes you excited to come to work everyday?

That I am working on a product which I strongly believe in and that I’m working towards a cause which is very personal to me.

And of course, the awesome team! Even though I am the only one based in Singapore at the moment, I know that I have a bunch of teammates who are super fun and helpful, and that they are just a phone call/ping/text/email away.

Q: What is the biggest lesson you’ve learned, based on your past experiences running and monitoring clinical trials?

Many organizations are heading overseas to conduct clinical trials for various reasons. This can include less red tape, easier patient recruitment and of course lowered costs. However, with this shift comes increased security risks. Every country has a different level of security and as such, some countries may be more prone to factors such as corruption and bribery. Factors that needless to say go against the very nature of clinical trials. Therefore, it is absolutely critical to always perform due diligence on your partners and vendors and their partners and subcontractors. Are they intentionally working in an insecure environment? Or are they doing so unknowingly? Regardless, it is important to know who you are working with and maybe more importantly who your partners are working with to better secure the integrity of the clinical trial.

Q: What are some best practices to avoid setup issues when crafting study protocols?

There are many things to consider for sure, but I would say that the very first thing to consider, which some people tend to forget, is to identify in which country the study will be conducted even before writing the protocol. This is because there may be different country or region-specific limitations or requirements. For example, the standard of care may vary in different countries. Country X may require 2 hours of post-visit patient monitoring, where the patient will have to stay 2 hours after the treatment and can only return home after the doctor determines that there are no adverse side effects, but Country Y may require 24 hours. I have seen many cases where this was overlooked and people end up having to make updates to their protocols, which in turn causes reworks and delays to their downstream activities as well.

Another common issue would be the failure to consider the synopsis and schedule of events before drafting out the full protocol. Since many parts of the protocol would be referencing the synopsis and schedule of events, if we have these two elements firmed up, it will prevent unwanted inconsistencies across the protocol. On the other hand, if we were to update the synopsis and schedule of events after completing the other segments of the protocol, then any changes to the synopsis and schedule of events will have to be reflected across the entire protocol. Again, this causes unnecessary reworks and not to mention, the risk of missing any updates.

Q: When designing manuals for clinical trials, what are the important elements to keep in mind?

I think it’s important to truly understand the person who will ultimately benefit from the use of the product and/or device. Therefore, I find it useful to walk myself through the entire process in the shoes of the intended user groups whether those are patients, physicians, healthcare workers, etc. I visualize all the possible scenarios that could take place, both good and bad. I try to envision all the various situations and potential issues that different end-user groups may face while following these manuals. Walking through these situations allows me to draft more concise and clearer instructions.

It may also be good to discuss with the end-users to see if there would be any logistical or other limitations that may pose difficulties to them in abiding to the instructions. If the instructions turn out to be near impossible to follow, you will end up with deviations that may impact the results of your trials. For example, if your patient manual calls for a -150°C freezer, chances are most patients won’t have one readily in their homes. So even if you have the best manuals, if your end users are unable to carry out the instructions, it’s pretty much useless.

Now for the really tough questions