Life Sciences and medicine have evolved to their present status due to consistent and persistent clinical trials. This evolution of medicine is of supreme importance due to its role in ensuring and assuring human longevity and the quality of life that should happen with additional years. Clinical trials form the core of research and development that brings about medical advancement. A clinical trial is about checking out ways and means to prevent, detect or treat diseases, and it is also a way to upgrade existing methods. We also have decentralized clinical trials to discover and find treatments for conditions that are surfacing for unfathomable reasons. The latest is Covid-19, which might have originated in China, but its subsequent variants developed all over the globe.
Before that, we had Ebola (still existent), traveling from Africa to the rest of the world. With every disease that makes its presence felt, we have to have clinical trials or, better still, Decentralized clinical trials to find treatments, as geographical boundaries or limitations do not limit the latter. These treatments might be completely new drugs or new drug combinations, new surgical procedures, devices, or upgraded ways to use the already existing treatments.
Therefore, the aims and objectives of clinical trials are to ascertain, first and foremost, whether the treatment works. Then, whether the treatment works safely without harmful and detrimental side effects. The second aspect of these trials is also improving and enhancing the quality of life for people who require constant care. This might be due to chronic illness or disability. Under the head of the clinical trial, the experimental intervention is applied to one or more groups of participants. The results or development of the applied therapeutics is compared and contrasted with the one given by the control group ( it could be a standard intervention, placebo, or even nothing). The most critical component of clinical trials or decentralized clinical trials is the availability of volunteer patients. Without proactive patients, causality in disease and patient care cannot be determined, be it the required outcome, adverse effects, or side effects.
A more patient-centric approach must be applied and practiced if clinical trials are to be successfully executed. Since a volunteer patient plays a pivotal role in the whole process of trials and results, the needs and values of an individual must be kept within sight. A critical approach to the entire procedure is that the clinical trial will not be carried out on the patient but with the patient. Their involvement gives insight and clarity on a specific treatment or drug. They will guide the template for treatment, cure, and care incorporated within health care systems.
Here, the volunteer patient must be completely upfront about his medical condition and history with his coordinator. To help the sponsors reach a successful fruition of the applied experiment. They must adhere to and comply with the procedure chalked by the research staff conducting the treatment. Participating solely for financial gains or free treatment of their ailment should not be the exclusive objective of the volunteer patient. They must faithfully report every reaction and response they observe post the drug administration. The patient participating in the trial must strictly follow the researcher's directives. Abstinence from smoking and consuming alcohol is vital as this can seriously interfere with trial outcomes. This, then, is the responsibility and role of the volunteers. But to get this commitment from them, the sponsors and specialist intermediaries have to them with care and sensitivity. They should not be made to feel they are just a source of responses and data.
The success of clinical trials largely depends on the availability of a timely and sufficient number of volunteer patients. Lack of these could lead to either the timeline of the clinical trial being extended, resulting in a hike in costs and resources, or long, lengthy clinical trials that delay the drug's availability. Therefore, the time-relevance of the drug still needs to be met. Secondly, the integrity and validity of the trial results are also hinged on the trial's sample size. If the sample size is inadequate, then an error might occur with the outcomes; e.g., the difference between treatments is not discernible when there is a difference. The clinical trial is shelved or abandoned, and the investment is completely wasted.
Delay in drug trials and the consequent drug manufacture is a significant challenge in clinical research and development enterprises that could also be attributed to patient retention. Although the failure of a trial could be due to many reasons, one glaring cause is the withdrawal of patient participants. A considerable amount of focused effort and attention has been unable to recruit and retain research participants, and the latter often leave the study mid-way. Data tells us that one successful, marketable drug has 10-15 years and US$1 billion behind it. Despite this significantly colossal investment of time and money, the percentage of failures could be better. 90% of drug participants in clinical trials fail. The reason is that the drug candidates are never really able to complete the course of the trial and reach the stage where the drug is approved for human consumption and manufacture.
A drug could only benefit patients if it can treat and cure them of an ailment they are troubled with. When we regard a drug as beneficial, it translates into what the usage of that drug is aimed at and its ability to produce desired results (efficacy). The possibility and magnitude of side effects (safety) are coupled. For patient recruitment and retention, safety forms one of the essential principles to be kept within sight throughout the drug development life cycle. Clinical trials are a collaborative effort of people responsible for the various stages of the trial.
This includes sponsors, researchers, healthcare providers, drug administrators, and patient volunteers. All of the above have to work towards securing patient safety. They must be sensitive to patients’ needs, comforts, and preferences. Sometimes, the medical staff/professionals are not appropriately trained to handle the clinical trial patients. Consequently, this limited training often results in the shoddy handling of the patients, and they, in turn, withdraw from the trial, leaving it midway. Besides, a very ambitious, enthusiastic clinical trial dissipates in its conception stage.
The investigators/researchers decide whether their trial will be an explanatory (efficacy) or a management (effectiveness) trial. They need to be explained in detail to patients. Sponsors and researchers must decide upon the model and design of their clinical trial before embarking upon the recruitment drive. Patients prefer to enroll for pragmatic trials; surgical practices could be a little more complicated.
Creating a patient recruitment strategy in place and as a priority is key to promoting patient recruitment for clinical trials. This should include the population study, the appropriate recruitment method, and the cost before a clinical trial begins. Recruitment methods include media deployment ( television, radio, web, and popular sites), physician referrals, press releases, fliers, random emails, and cold calls. Outreach methods should be process-oriented, organized, efficient, and patient-centric.
The investigators need to consider the patient's point of view and give them a detailed explanation of all that is required to do. This will ensure that the patient is not loaded with an unnecessary burden. A survey might be conducted to determine the patient's concerns and preferences. The preference may veer toward observational trials, interventional trials for a treatment for side effects, and finally, for new treatments and drugs. One such survey found that patients with chronic ailments are more for investigational treatment than in trials for a new medicine or therapy.
A healthcare worker’s or a doctor’s referral is more weighty in effectively getting patients to volunteer or enroll for clinical trials. A CISCRP(Centre for Info & Study on Clinical Research Participation - Boston - Massachusetts) survey found that 64% of patients respond best to a referral about a clinical trial directly from their healthcare provider.
Recruitment is often adversely affected because patients need help understanding what is expected of them or the clinical trial. Suppose the medical literature specifically designed for medical practitioners is used here to convey patient information. In that case, they might be more receptive and ready to enroll for the clinical trial. Local networks with hospitals, healthcare providers, and sites that connect people can be used to spread awareness of the trial among patients.
Patient advocacy groups are a unique platform for developing patient engagement approaches. These groups are banks keeping information on patients, care workers, current research, availability of treatment options, and daily support systems. They have direct access to patients and can use their feedback to enhance the patient-researcher quotient. It is always advisable to connect with a patient-centric clinical trial recruitment company. These companies have a sympathetic patient engagement policy that works to eliminate impediments and delays in medical research. These companies also have an effective outreach plan to onboard patients for the proposed clinical trial.
Digital media campaigns are other dynamic means of going beyond the existing databases to reach patients regardless of geographical boundaries. An online-outreach campaign with interest, keyword, and SEO (search engine optimization) could efficiently target patients looking out for treatment options and care. A Clinical trial sponsor could use cookie tracking systems, online advertisements, and retargeting campaigns to keep appearing before the same patient multiple times to capture his attention and make him consider participating in the trial.
These clinical trials use technology, and the covid-19 pandemic has already brought home how much easier and safer these decentralized clinical trials are. Even if the trial is decentralized, the patient's presence is required, and partnering with a local lab can serve the purpose. So providing localized lab services removes obstacles in patients' active and quality participation.
Cold calling results in a lot of waste of time and money. Creating a database and contacting patients who are willing volunteers for clinical trials is always advisable. This can be pre-determined with the help of some specific services, such as lab tests and Electronic Health Record companies, that have access to patient data. Sponsors can thus reach a large population of patients who might be interested and eligible for the clinical trial.
Patient prevarication is another factor that can delay the start of the trial. They might be interested in coming aboard the trial, but formal signing is not their priority. So a follow-up is constantly needed to nudge them toward participation. For this purpose, texts, e-mails, and other site follow-up services are required to save money and reduce the patient drop-out rate.
Patient retention and post-patient recruitment are of utmost importance; these work hand-in-hand for the best results. There are many other ways to ensure patient engagement:
Along with the aforementioned poitns, a patient is "well engaged" if he has a happy experience dealing with on-site personnel. Therefore, conveniences provided to the recruited patient could go a long way in keeping him committed to the trial.
Therefore, companies or CROs planning a clinical trial should focus on the long-term availability of patients at the start of the study. This measure would significantly reduce their overall expenses and mobilize a broader range of suitable patients across multiple sites. A Medical Research Council UK recommendation suggests that it would contribute hugely to patient recruitment if local patient advocacy groups and organizations were roped in to give their input on the trial design. There is no single action that will resolve the issue of reluctant patients but a combination of several steps that companies can take to enhance patient recruitment and sweep away their resistance. A well-thought-out action plan is the call of the hour to increase patient enrolment and long-term retention.
Mahalo Health is a healthcare platform that provides the industry with a fully equipped platform to store patient data, interact with patients and monitor their health remotely. From decentralized clinical trials to digital therapeutics and remote patient monitoring, Mahalo Health has the perfect technological solution to supplement your healthcare practice and engage your patients in a satisfying diagnostic experience. Reach out to us today!
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