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Clinical Trials - The New Normal Post Covid-19


by Asad Balal

Normally on a Friday, I would be working till around 5pm and planning my weekend ahead. The loss of activities normally include spending time with my family & friends, binge watching a new series on Netflix, spending time watching Football (Soccer for those in the US) along with other sports, doing some housework (Hoovering, Ironing & Gardening) & of course eating some delicious food!!

This weekend under the current situation I will be reading & researching about Clinical Operations, Research & Affairs across the globe. This is something I am passionate about and once you get me started… I will not stop.

The last 5-7 weeks have been a bit of struggle within most industries across the world but it has affected the world of Clinical Trials in a way that none of us could ever imagine it.

REMOTE MONITORING: Over the last couple 3-4 weeks I have spent a lot of hours speaking to CRA’s, Monitors & Site management staff who have shared the same opinions as me when it comes to clinical monitoring on sites. Unless you are doing a COVID-19 study, most Clinical Trials are on hold, cancelled or delayed unless the companies have access to remote monitoring. From past experience only a few companies across the globe specialise in remote monitoring. Clinical staff who are normally travelling to sites are now helping out where they can by doing feasibility activities whilst being at home. The coming months we will see an increase in adapting to remote monitoring, but I often hear monitors are not the same as being on site and the information will never be as efficient. Let’s see how things progress but this is definitely one to keep an eye on. 

DOING IN-HOUSE CLINICAL TRIALS THEN OUTSOURCING: I have had the opportunity to speak and liaise with just over a 100 VP’s, Head’s & Director’s of Clinical Operations in the past month. The conversations have been mind blowing to understand how the COVID 19 situation will have an impact on sponsor companies when it comes to undertaking new clinical trials. At the moment most biotech, pharma & clinical stage companies tend to outsource their clinical trails to CRO’s across the globe but this could change in the coming months & years as companies look to be more cost efficient. Some Individuals mentioned to me that they can have their inhouse Clinical Project or Trial Managers, line managing Freelance/ Contract CRA’s across the globe and only outsource Data Management/ Bio-Statistics to a specialist consultancy or a more data focused CRO. Some companies do it already and it does prove to be a cheaper option.

INCREASE DEMAND FOR CONTRACTORS: It’s been a tough time for most freelance & contract individuals across the globe as local governments are not helping them the same way as they would be full time permanent employees. I think that having hours worked, hours paid, individuals across the globe on your clinical trials may prove to be the way forward for all Pharma, Biotech, Clinical Stage & Device companies. So many start-up to medium companies have made a lot of people redundant over the last 3-4 weeks Internationally because the realisation sunk in of not having enough work for full time employees available. If you have contractors who are paid on work undertaken basis, then this could prove to be more cost efficient and if another situation like COVID-19 arises, then you could be in a better position to manage the financial burden. This doesn’t apply to all positions in a company, only particular jobs.

CLINICAL RESEARCH ORGANIZATIONS – ADAPTABLE TO CHANGE: Over the past few days I have delved further into the CRO world to see how they are coping with the current COVID-19 epidemic for their sponsor trials. It’s been a tail of two stories, some CRO’s have been productive and are carrying on things normally across certain countries globally but some are really struggling with a lack of work for their internal employees which has led to redundancies and also cuts on clinical contractors. It’s heart-breaking as I know so many people working for these CRO’s and its no fault of their own that this has happened. Going forward I think some of the small to medium size CRO’s will have a lot of success with new sponsor business as the big CRO’s tend to sometimes take on too much work and don’t prioritise sponsor studies which sometimes gives them a bad image in front of decision makers at Sponsor clients. That being said I’m looking forward to seeing how the CRO world will evolve in 2020/2021.

As mentioned above, once you get me started on Clinical, I can talk for hours and hours without stopping. On a side note, I wanted to mention that these are tough times for everyone involved but I’m sure together as one we can overcome this great obstacle and make the world a better, healthier & safer place for the current & future generations.

In conclusion, I just wanted to remind everyone who is reading this, “The world is full of nice people so if you can’t find one, be one.