Clinical research is making massive strides in the way we treat illnesses, extending length and quality of life for the patient. Making the breakthroughs possible are medical researchers who rely heavily on the willingness of men and women prepared to take part in research programmes.
Crucial to the work is identifying the right people to take part in trials and one of the companies leading the process is Quintiles, which is using ever-more sophisticated methods to identify the best subjects worldwide.
The company, which was associated with the development or commercialisation of all of the world’s top 100 best selling products or compounds in 2013, works across the full range of therapy areas from respiratory and cardiovascular to mental health, oncology, neurology and immunology.
A key part of its work is making people more aware of the massive impact which clinical trials are having on developing new medicines that can reduce death rates or improve quality of life for many conditions including cancer and heart disease, and also addressing some of the public disquiet about the process.
Quintiles employs more than 950 MDs, 900 PhDs and thousands of clinical educators and medical representatives among its network of 30,000 employees in 100 countries and selecting the right people to take part in research is at the heart of their work.
Senior Director, Health Engagement and Communication, Ruth Slater said: “Recruiting the right people can be a complex process. It is important that we profile the person taking part before they join a research programme to make sure that we have the right person.
“We have to determine what are their physical considerations, are they mentally prepared to go through the process, are they engaged enough to stick with the research. This is in addition to making sure that they are the right age and the right demographic so that we truly represent the community. There are a lot of questions to answer before we decide that they qualify for the research itself.
“A lot of our work is about identifying people early. Much of the clinical work being undertaken today is focused on prevention and spotting symptoms as early as possible so our work is geared towards identifying and enrolling people who fit into that category.
“That is true, for instance, in neurology research where identifying symptoms in conditions such as Alzheimer’s is important. The same is true of the vascular field.”
Finding the best subjects
To find the right people and connect them with opportunities to participate in clinical research, the company works in different ways, both digital and on the ground through networks of health organisations at work in communities. One of the most effective methods of connecting patients with research opportunities has been the MediGuard.org site, which is owned and operated by Quintiles. The primary purpose of MediGuard is to promote improved communication directly with patients or healthcare “consumers”to help people understand, and safely use, their medication. By providing up-to-date safety alerts/recalls, along with feedback and reviews from other members, the service is able to help people make more informed decisions regarding their health.
More than 2.6 million patients in the USA, UK, France, Germany, Spain and Australia have registered from MediGuard, making it one of the largest and fastest-growing health care communities in history and providing a pool of people who have opted-in to be contacted about research opportunities.
Ruth Slater said: “The people who use MediGuard are important because they have already indicated that they wish to learn more about their medication, so are the type of people who might also consider taking part in research. We are able to provide the very latest information on opportunities to take part in upcoming clinical research programmes directly to patients who are of a likely medical profile to be eligible to participate. This is done in a completely anonymous way, which means that patient confidentiality is achieved throughout the recruitment process, thus helping to maintain public confidence in digital recruitment processes.
“We recruit a lot of our subjects through advertising in the digital space. We also acknowledge, however, that there are people out there who do not engage with the digital world but very often they have friends or relatives who do.”
To emphasise the potency of digital recruitment, Quintiles points to not just MediGuard.org but also its site ClinicalResearch.com. Recruiting such people in a timely fashion is just one way that Quintiles helps customers to improve their probability of success, through faster and more productive clinical trials.
Understanding human behaviour key to recruitment
The ultimate aim is to deliver measurable results from data-rich programmes, capturing real-time clinical indicators and patient outcomes which feed into drug development programmes and post-approval safety and real world outcomes monitoring.
The company’s experience is drawn from helping to develop or commercialize 100% of the Top 100 best-selling products or compounds of 2013. From 2008 to 2014, Quintiles conducted more than 400 direct-to-patient studies in more than 30 countries and programs in the last 10 years has enrolled more than 9M patients in observational and quality improvement in more than 100 countries with more than 55,000 sites. In addition, it has supported more than 220 product launches in 20 countries since 2009.
One of the key areas on which the company concentrates is behavioural research because understanding the barriers which prevent people taking part in trials saves time and ensures more effective outcomes.
Despite the many successes regularly reported by research teams, many people remain unconvinced, or unaware, of the importance of clinical trials or indeed of opportunities to participate in clinical research. Quintiles believes that the lack of awareness about medical issues generally is caused by factors including a lack of understanding, poor literacy, and some people’s distrust of medicines and doctors.
Meta-analysis of more than 300 different patient surveys, conducted through Mediguard revealed that:
• Fewer than 10% of patients across all therapy areas have ever participated in a clinical trial
• Key reasons for lack of participation are that patients are unaware of clinical trials or have not been asked to participate
• An average of ~72% of patients express an interest in being contacted about local, relevant clinical trials
Ruth Slater said: “Real-world data has become so important and we are working to raise awareness of the importance of research across the world.
“A lot of our work is done in the US where much of the innovation in the field is being carried out and where there is an appreciation of the importance of research but we are working to broaden the opportunities for people both in the US and elsewhere in the world.
“Public understanding of the importance of research differs from country to country, culture to culture and we are working to spread the network and bring in people in the early stages of an illness, which is a key part of that work.
“However, we acknowledge that for some people there is a reluctance, even a fear factor, about taking part in medical research and we are trying to address that. With only one-half of patients who have chronic diseases adhering to treatment recommendations in developed countries1, adherence is a major issue.”
The result is that patients do not gain the full benefit of their treatment, resulting in a knock-on effect for the healthcare system, which experiences inefficient use of already scarce resources in the short-term and increased long-term costs.
There are consequences for the biopharma industry as well because its innovative products are not used effectively, leading to lower efficacy and diminished perceptions of the value of the product.
But the real impact is human, accounting for about 125,000 lives in America alone and at least 10 per cent of hospitalizations each year, with annual costs to the U.S. healthcare system of $100 billion to $289 billion.2
In the European Union, non-adherence is estimated to cause 194,500 deaths each year3, costing €1.25 billion5.
To counteract the lack of awareness, Quintiles supports initiatives which emphasise the success of medical research programme, including International Clinical Trials Day, which takes place every year on May 20, the day that James Lind began the first ‘fair test‘ clinical trial in 1747 into scurvy. Lind is considered the first physician to have conducted a controlled clinical trial of the modern era when, while working as a surgeon on a ship, he became appalled by the high mortality rate for scurvy amongst the sailors.
He conducted a trial of potential treatments, which led to him identifying oranges and lemons because of their high vitamin content although because they were expensive, it was nearly 50 years before the British Navy eventually made lemon juice a compulsory part of the seafarers’ diet, and this was soon replaced by lime juice because it was cheaper.
Trials have continued to prove their worth ever since including the first modern clinical trial was conducted by British epidemiologist Austin Bradford Hill who in 1946, conducted a study which identified streptomycin to treat tuberculosis. Their success has also been demonstrated through the impact of new medicines on survival rates in three major diseases.
US cancer deaths declined for the first time since 1930 in the early 2000s, with 369 fewer deaths in 2003 and 3,000 fewer deaths in 20044. Advances in diagnosis, radiation and surgery have all played a part but new drugs have transformed treatment and survival.
Before the first AIDS drug was approved in 1987, HIV/AIDS diagnosis was a virtual death sentence. HAART (Highly Active Antiretrovial Therapy), introduced in 1996, now makes HIV manageable. In 1993, before HAART, the average life expectancy from diagnosis for Americans with HIV was seven years5. Today, a 20-year-old adult who is receiving antiretroviral therapy can expect to live into his or her early 70s.6
Broad use of cholesterol-lowering drugs to reduce deaths from coronary heart disease is now recommended by the U.S., Canada, U.K. Europe, Australia and New Zealand. Meta-analysis of 17 clinical trials (21,303 patients) showed a 20% to 30% reduction in death among at-risk patients taking statins.7
Ruth Slater said: “We work hard to raise awareness so that people realise that taking part in research can benefit not only themselves but also benefit society. With some people, it’s not a case of being unwilling to be involved but rather not being aware of the benefits.”