The clinical trial landscape has drastically changed since the last millennium, forcing all those involved to adapt and those resistant to change to quit. An era of paper case report forms (CRFs), faxed patient laboratory reports and post it notes has since evolved to the 21st century way of conducting trials – adapting from an era where clinical trials were very simple, regulations were clear, regulatory authorities were efficient, and sponsor companies provided more support in the conduct of trials. This evolution has left many to reminisce on the halcyon days where all stakeholders involved worked on inventing novel drugs that could better the lives of patients and cure them of dreadful, incurable diseases.
The 21st century has forced the Old Guys to adapt to new ways and methods while technology has since replaced antiquated models of conducting clinical trials.The current conduct involves using computers and expensive medical equipment which interprets results on behalf of investigators. Mobilephones have replaced the traditional ways of communicating; electronic CRFs have replaced paper CRFs, while onsite monitoring visits have been replaced by disruptive telephone calls, remote monitoring visits and long emails resulting in most investigators perceiving the change as unproductive, inefficient and cumbersome. Like every change in life, many have become resistant and struggled to adapt to this "Evolution" with some questioning whether it is this worthwhile to conduct trials at all.
Investigators long for those days where they were hands on, where monitoring was onsite and they would engage with monitors, working in unison to identify, correct site errors and discrepancies prior to an audit or inspection and ensure that their sites produce good credible data. For some, it is the longing for belonging and feeling like a part of the bigger picture. The replacement of the lavish overseas meeting with local meetings or teleconferences, the lack of opportunity to network with their international peers and very little possibility to engage with the sponsor companies on a personal level has left many feeling disconnected, that the industry is moving towards alienating stakeholders and forcing them to act as an individual instead of a collective.
It is often argued that sponsor companies leave much of the work to investigators, that terms like remote monitoring, targeted monitoring, reduced source data verification have been introduced to sugar-coat the reality that sponsors are doing less and investigators are doing more, that technology has removed the focus from conducting clinical trials in a real life setting. The practical conduct where a patient/investigator relationship existed is fast becoming so programmed leading to compromised data, reduced quality and has removed the human element, leaving investigators anxious and questioning if they are audit or inspection ready. On the other hand, sponsor companies are seen to be more profit driven, making sure they generate enough revenue before their patent period expires.
With all that said, how does one ensure that all stakeholders are engaged, that all embrace the change that comes with this "Evolution"? How do we ensure everyone involved realize the positive change this brings and see the benefit of evolving from the Old ways?
In my opinion education, consultation and making everyone comfortable with the "New Ways" is a start to safeguarding a smooth transition. Getting a buy in from the people who have long been in the game, finding out what works and doesn’t work could make all the relevant parties affected to feel like they have contributed to the change. A lot of investment will need tobe made onpeople working on the ground, making them understand that technology doesn’t take away the quality of data produced; instead it certifies that more measures arein order for good credible data to be produced, captured and analysed. Instead of seeing technology as the enemy, it should be viewed as the solution. Instead of seeing less physical contact with the monitors’, investigators should see this as industry’s way of recognising the need for them to conduct trials in a manner that doesn’t make them feel policed. This should be seen as a way industry empowers them to make clinical evaluations in the real investigator/patient setting.
In most cases, regulatory requirements may drive the need to have certain ways changed, how this is communicated also plays a vital role. Sponsor companies need to remind investigators of everyone’s roles and responsibilities as outlined in ICH-GCP and the fact that when change is made, local and international laws warrants the change. As with any change in life, when people feel engaged they are more responsive as compared to when change is forced on them. Everyone’s mind sets and the perceptions that this Evolution is tedious, time consuming and not so cost effective will also have to change to ensure smooth adaptation.
We all need to realize the reason why they conduct clinical trials in the first place – the need to bring novel medication to patients to help cure diseases and better the lives of patients. It is understandable that change can be difficult, but the need to conduct trials efficiently without compromising and exploiting patients, and ensuring ICH-GCP is followed is essential. If we keep to why we do trials in mind, it will be easy for us to embrace change.
The reality is that this "Evolution", the strict regulations, reduced source data verification, intense quality checks and ethical reviews are solutions put in place to ensure that all stakeholders own up and account for their responsibilities, that good credible data is produced, ensuring ethical conduct of carrying out trials.
*Sehlomola Mashatole has 8 years experience in the pharmaceutical industry and has worked for Clinical Research Organisations, Multinational Pharma and Biotech Companies. The views presented in this article are strictly those of the author and not of Amgen‘s