Patient recruitment and engagement standards

In the past it was absolutely crucial to do feasibility research on the clinical research sites that will run your clinical trial and this usually meant that patient recruitment was ensured. Many pharmaceutical companies who were sponsoring clinical trials, as well as their partners the clinical research organisations, were putting their efforts into estimating how successful their sites are likely to be.

They were gathering as much data as possible - global, local, whatever they have access to, to predict what their clinical trial process would look like. One of the key metrics was the number of patients they would have. And this is still relevant. In fact, clinical trial site selection is even more crucial, but in most cases the fact that the whole industry has proven that doesn’t ensure getting enough patients on board.

Patient recruitment and their engagement throughout the clinical trial has been one of the hot topics in the last couple of years. And not because we think it is so interesting (although it is) or because it is just a current topic. But not being able to recruit enough participants is one of the main reasons why nine out of ten clinical trials fail, causing losses every single day for the pharma companies that are sponsoring the clinical trials of between $600,000 and $8m. And this causes real difficulties - both for the industry and for all of us - patients, caregivers and potential patients. Promising treatments that could reach the market never do.

If it is causing so many difficulties, what are we doing about it? This is the question you might have asked yourself by now. Well, whatever we can. More and more, companies are investing in gathering data about patients and their behaviours. Third-parties invest in creating technologies for EHR matching to clinical trials. Organisations like the Alliance for Clinical Research Excellence and Safety (ACRES) are moving the industry forward by creating better standards for investigator sites. Regulations are being changed so that we can interact with patients through new channels like social media and apps.

And the reality: 50% of clinical research sites don’t recruit a single patient. The vast majority of clinical studies still rely on doctors and nurses to supply patients who fit certain trial parameters. The initial screenings only consider the potential subjects who frequent their practice, restricting the pool of participating patients. It often takes months, and even years, to recruit the requisite number of patients to render the trial results scientifically trustworthy. And only a few people are somehow aware that clinical trials exist and are not experiments.

This is one of the reasons the industry is screaming for better standards - to improve patient recruitment and engagement in clinical trials and also to speed up the clinical research processes. There are many efforts in this direction, but very few have developed into an actual result. I am part of this initiative as one of the working groups within ACRES (www.acresglobal.net) where we have created a group of top-level stakeholders from different parts of the industry and started a guideline on the new industry standards in this space. The standards describe:

*Processes by which potential study participants are informed about clinical trial opportunities

*Understanding the profile of patients for whom each clinical trial represents a viable treatment option

*Requirements for recruiting participants

*Guidelines for detection of potential issues in individual patients that may impact on recruitment (medical and legal questions, logistic difficulties, vulnerable patients, etc)

*Pre-qualifying potential participants

*Understanding and mitigating obstacles for ongoing participation in a study

*Guidelines for participant retention

*Guidelines for detection of potential issues in individual patients that may impact on retention.

Patient awareness is one of the most important topics of discussion and is extremely critical. A number of studies have revealed that awareness changes patients’ perceptions about clinical trials, enrolment and the risk/benefit ratio of getting involved. The Harris Interactive Survey shows that 85% of patients were either unaware or unsure that participation in a clinical trial was a viable option available at the time of their diagnosis. Moreover, 75% of said patients indicated their willingness to sign up if they were offered this possibility.

A complementary survey was conducted among a group of 100 patients who applied for trials through FindMeCure - the global database of clinical trials for patients, specifically focused on their information needs. The results divulged the main content channels the patients valued most, and these insights can help in creating appropriate information tools or marketing materials. Participating patients cited that information gleaned from these two sources greatly contributed to their decision to take part. This evidently demonstrates that access to better quality and quantity of information paves the way to greater results for patients.

But how do we ensure exactly the quality and quantity of information on the internet and social media? This was also one of the topics at the Patient Summit Europe this year. There were two roundtables with key figures representing the pharma industry and patient organisations. We were independently speaking about the future of digital platforms and how we can use them to better engage with patients. We all agreed that such platforms are invaluable for:

*Granting better access to patients

*Creating a more valuable connection between patients and healthcare providers

*Enabling patients to get support from others and share their experiences

*Educating patients

*Replacing the face-to-face interaction where possible and thereby saving time and money

*Monitoring patients’ conditions, tracking their behaviour and providing them with valuable content for managing their health.

All these purposes have two-sided benefits and there is no doubt that this is the future. But besides the potential, they are also hiding some real risks. The implementation of the internet and mobile devices can accelerate the speed of data collection with enhanced data quality and the ability to merge data using advanced Electronic Data Capture (EDC) systems. However, it is crucial that privacy and ethical protocols are enforced to allay any security or privacy concerns of patients.

With deploying technology, some of the questions that need to be addressed include:

*How can technology solve the problem of a lack of patients in clinical trials?

*Why do clinical trials continue to go unrecognised as an important and viable treatment option?

*What are the reasons and recommended adjustments pharma needs to incorporate to earn the trust of a higher number of patients?

*How to identify collaborators who can supply solutions?

Certainly, there is no one correct answer to all these questions. However, there is one first step that guides the securing of the quality of Internet information and ensures personal data security. And as trivial as it might sound, again, these are the standards. Yes, standards as regulations. Guidelines that will unify the information we are supposed to generate so that we can provide value instead of uncertainty. A description of what ‘right’ should mean.

And we all agree that in most cases regulations slow down innovation and execution. At the same time this is the only way we can ensure safety and quality, so it is all a matter of finding the right balance.